CAMBRIDGE, Mass.--(BUSINESS WIRE)--Magenta Therapeutics (NASDAQ: MGTA), a clinical-stage biotechnology company developing novel medicines to bring the curative power of stem cell transplant to more patients, today announced final clinical results from its earlier completed Phase 1 clinical trial as well as development updates for its MGTA-145 stem cell mobilization therapy, including commencement of enrollment in a Phase 2 clinical trial in multiple myeloma, and its plans for a Phase 2 clinical trial in allogeneic stem cell transplant for patients with acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) and myelodysplastic syndrome (MDS). The company also previously announced a clinical collaboration with bluebird bio to evaluate MGTA-145 for mobilizing and collecting stem cells in adults and adolescents with sickle cell disease (SCD). Additional preclinical results were also presented at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, taking place virtually from December 5-8, 2020, on the Magenta conditioning platform, including MGTA-117 program, which is a targeted antibody-drug conjugate (ADC) to prepare patients for stem cell transplant.

MGTA-145 Advancement to Phase 2 Development in Blood Cancers

The company announced that enrollment has started and is ongoing in a Phase 2 clinical trial of MGTA-145, used in combination with plerixafor, to mobilize and collect stem cells for autologous stem cell transplantation of multiple myeloma patients at Stanford University. Magenta expects that this trial will provide patient-level data on stem cell mobilization and collection, characteristics of the mobilized graft and engraftment in patients with multiple myeloma.

Additionally, through a collaboration with the National Marrow Donor Program/Be The Match, a global leader in facilitating allogeneic hematopoietic stem cell transplantation, Magenta plans to initiate a Phase 2 clinical trial in early 2021 using MGTA-145 to mobilize and collect stem cells from allogeneic donors for transplant in patients with AML, ALL and MDS. Allogeneic stem cell transplant provides a potentially curative therapeutic option for patients with these diseases. This clinical trial will evaluate stem cell mobilization, collection, cell quality, engraftment and the potential for reduced Graft-versus-Host Disease (GvHD), which is of particular importance in the allogeneic transplant setting.

MGTA-145 in Sickle Cell Disease

Magenta Therapeutics recently announced an exclusive clinical collaboration with bluebird bio to evaluate the utility of MGTA-145, in combination with plerixafor, for the mobilization and collection of stem cells in adults and adolescents with SCD.

The data from this clinical trial could provide proof-of-concept for MGTA-145, in combination with plerixafor, as the preferred mobilization regimen for patients with SCD. bluebird bios experience with plerixafor as a mobilization agent in SCD aligns with Magentas combination therapy approach, utilizing MGTA-145 plus plerixafor with potential for safe, rapid and reliable mobilization of sufficient quantities of high-quality stem cells to improve outcomes associated with stem cell transplantation.

MGTA-145 Presentations at ASH

Magenta presented final clinical data from its MGTA-145 stem cell mobilization Phase 1 clinical trial in healthy volunteers at the ASH Annual Meeting. All primary and secondary endpoints were met in the study completed earlier this year.

The results demonstrate that a single dose of MGTA-145, in combination with plerixafor, rapidly and reliably mobilized high numbers of stem cells in a single day without the need for G-CSF for potential use in diseases that can benefit from autologous and/or allogeneic stem cell transplantation. The additional data also offer further confirmation that MGTA-145, in combination with plerixafor, was well tolerated and provides a rapid and reliable method to obtain large numbers of hematopoietic stem cells. Transplant of these cells in preclinical models resulted in enhanced, durable engraftment, in addition to highly immunosuppressive properties, leading to reduced GvHD.

Results from this study provide a robust dataset and proof of concept that MGTA-145, in combination with plerixafor, provides rapid and robust mobilization of stem cells and that these cells have better engraftment potential, are able to be gene modified and engraft and reduce GvHD in preclinical models compared to cells mobilized with other available agents. The data reinforce the availability of compelling opportunities for development in both the autologous and allogeneic transplant settings, said John Davis Jr., M.D., M.P.H., M.S., Head of Research & Development and Chief Medical Officer, Magenta Therapeutics.

The data were presented by Steven M. Devine, MD, Chief Medical Officer of the National Marrow Donor Program/Be The Match and Associate Scientific Director of the CIBMTR (Center for International Blood and Marrow Transplant Research).

Conditioning Program (MGTA-117 and CD45-ADC) Presentations at ASH

Magenta also provided updates on its conditioning platform at the ASH Annual Meeting, including MGTA-117 and CD45-ADC programs. Preclinical data from a study of MGTA-117 demonstrate that it is an effective, potent conditioning agent for transplant with anti-leukemic activity, significantly decreasing tumor burdens, leading to delayed tumor growth and increased median survival rates in animal models of AML. Ongoing GLP toxicology and GMP manufacturing progress continue to be supportive of advancing MGTA-117 towards an IND filing in AML and MDS.

Additionally, preclinical data from a study of Magentas CD45-ADC, a CD45-targeted conditioning agent designed to remove the cells that cause autoimmune diseases to enable curative immune reset, demonstrated the ability to achieve successful outcomes as a single agent in the most challenging disease model through fully mismatched allogeneic hematopoietic stem cell transplant, where only radiation or combinations of toxic chemotherapies are available, potentially providing patients the option of a reduced toxicity conditioning regimen. The company continues to evaluate this program preclinically.

About MGTA-145

MGTA-145 is being developed in combination with plerixafor to harness complementary chemokine mechanisms to mobilize hematopoietic stem cells for collection and transplantation. This new combination has the potential to be the preferred mobilization regimen for rapid and reliable mobilization and collection of hematopoietic stem cells to improve outcomes in autologous and allogeneic stem cell transplantation, which can rebuild a healthy immune system for patients with blood cancers, genetic diseases and autoimmune disorders.

MGTA-145 has the potential to replace the current standard of care for patients and allogeneic donors who currently rely on the use of granulocyte-colony stimulating factor (G-CSF) alone or in combination with plerixafor, which can take up to five days or longer to mobilize sufficient numbers of stem cells, often resulting in significant bone pain and other side effects.

About Magenta Therapeutics

Magenta Therapeutics is a clinical-stage biotechnology company developing medicines to bring the curative power of immune system reset through stem cell transplant to more patients with blood cancer, genetic diseases and autoimmune diseases. Magenta is combining leadership in stem cell biology and biotherapeutics development with clinical and regulatory expertise, a unique business model and broad networks in the stem cell transplant world to revolutionize immune reset for more patients.

Magenta is based in Cambridge, Mass. For more information, please visit http://www.magentatx.com.

Follow Magenta on Twitter: @magentatx.

Forward-Looking Statement

This press release may contain forward-looking statements and information within the meaning of The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as may, will, could, should, expects, intends, plans, anticipates, believes, estimates, predicts, projects, seeks, endeavor, potential, continue or the negative of such words or other similar expressions can be used to identify forward-looking statements. The express or implied forward-looking statements included in this press release are only predictions and are subject to a number of risks, uncertainties and assumptions, including, without limitation risks set forth under the caption Risk Factors in Magentas Annual Report on Form 10-K filed on March 3, 2020, as updated by Magentas most recent Quarterly Report on Form 10-Q and its other filings with the Securities and Exchange Commission. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this press release may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. Although Magenta believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur. Moreover, except as required by law, neither Magenta nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

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Magenta Therapeutics Announces Commencement of First Phase 2 Clinical Trial of MGTA-145 for Stem Cell Mobilization, Oral Presentation of MGTA-145...

Recommendation and review posted by Bethany Smith

JERUSALEM, Dec. 8, 2020 /PRNewswire/ --NeuroGenesis, a clinical-stage biopharmaceutical company advancing innovative cell therapies to combat myelin-related neurodegenerative diseases, and Hadassah Medical Center announced today highly positive results from a placebo-controlled Phase 2 clinical trial, headed by Prof. Dimitrios Karussis, together with Dr. Petrou Panayiota and Dr. Ibrahim Kassis from Hadassah Medical Center in Jerusalem, assessing the impact of NG-01 autologous proprietary subpopulation of mesenchymal stem cells (MSCs) on patients with progressive multiple sclerosis (MS).

The results, recently published in Brain, a prestigious peer-reviewed journal published by Oxford University, and highlighted in the "Editor's Choice", show that:

"The treatment was well tolerated and the trial met all of its primary endpoints," said Professor Dimitrios Karussis, lead principle investigator and Director of MS Center at Hadassah Medical Center, Jerusalem. "The patients' improvement was in many cases quite remarkable and included regain of motor function and noticeable effects on their cognitive abilities."

Prof Karussis added, "Although we currently have several good treatment options for relapsing remitting MS, we fall short in providing effective treatment for progressive MS that could substantially suppress the progression of disability. This trial provides encouraging results and suggests a potential for a new approach that may not only slow down the progression of the disease but even induce improvement and promote repair mechanisms in progressive MS."

The technology is now further developed by NeuroGenesis, following a license from Hadasit, Hadassah Medical Center Technology Transfer Company.

Neurogenesis' technology entails collecting bone marrow from the patient. Then by utilizing a proprietary process, a unique subpopulation of bone marrow cells is identified, cultured and enhanced towards remyelinating biofactory cells (NG-01) that also possess neurotrophic immunolatory and neuroprotective properties. The NG-01 cell population is injected directly into the central nervoussystem (through the cerebrospinal fluid), where the cells home-in on the damaged area, take up residence and produce significant amounts of neurotrophic factors.

"Progressive MS is a chronic, debilitating disease with no satisfactory treatment to improve or reverse established disability," said Tal Gilat, CEO of NeuroGenesis. "We are therefore extremely pleased to witness the significant positive effect of our NG-01 cells. Following recent interactions with the FDA, we look forward to confirming and expanding these findings in a large multi-center MS trial, and continuing advanced studies in additional indications such as ALS."

About the Phase 2 trial of NG-01

The Phase 2, randomized, double-blind, placebo-controlled, clinical trial assessed the safety, tolerability and efficacy of transplantation of NG-01 in people with progressive MS. The study enrolled 48 participants with progressive MS which were randomized into 3 groups, receiving either an intrathecal or intravenous NG-01 injection, or a placebo injection.

The two predetermined primary endpoints of the trial were: (i) the safety of the intrathecal and intravenous NG-01 treatments assessed by incidence of adverse events versus those in the placebo-treated group; and (ii) the differences among the three groups in the Expanded Disability StatusScale(EDSS) score changes and the proportion of patients with treatment failure, as evidenced by an increase in EDSS (disease progression) score, at 6 and 12 months. Overall, the study duration was 14 months.

About Multiple Sclerosis

Multiple sclerosis (MS) is an autoimmune disease that causes damage in the myelin and the nerve cells of the central nervous system (demyelinating plaques in brain and spinal cord), resulting in cumulating neurological disability. The destruction of the myelin (the covering that protects nerves and promotes the efficient transmission of nerve impulses) causes secondary damage to the nerve cells and progressive atrophy. MS often causes sensory disturbances in the limbs, including a prickling or tingling sensation (paresthesia), numbness, pain, and itching. Motor problems are common in people with MS. Affected individuals may have tremors, muscle stiffness (spasticity), exaggerated reflexes (hyperreflexia), weakness or paralysis of the muscles of the limbs, difficulty in walking, and poor sphincter control. The condition is also associated with visual problems, such as blurred or double vision or partial or complete vision loss. There is no known cure for multiple sclerosis.The existing treatments are mostly aimed to reduce the incidence of relapses of the disease and slow down the rate of neurological deterioration.

About NeuroGenesis

Neurogenesis is developing cell therapy for neurodegenerative diseases based on a unique approach for sustained delivery of high levels of remyelinating growth factors using the patient's own stem cells. The technology for this unique approach was licensed from Hadasit, theTechnology TransferCompany of Hadassah Medical Organization in Jerusalem, Israel. The Company's lead product is NG-01 for the treatment of progressive Multiple Sclerosis, (in which a placebo-controlled Phase 2 study has been completed and recently published). NG-01 were also tested in two successful Phase 2a trials in ALS patients. Up to today, more than 150 progressive MS and ALS patients from around the world have been treated with Neurogenesis'products via clinical trials (Phase 1 and Phase 2) and compassionate use treatments.

About Hadassah and Hadasit

For more than a century, Hadassah has set the standard of excellence for medical care and research in Israel. Our doctors and scientists are on the frontlines, uniquely positioned to pinpoint ever-evolving medical needs. Their experience and ingenuity have yielded new ideas with huge potential in all areas of medicine, including therapeutics, diagnostic medical devices, and digital health. Hadasit is the technology transfer company of Hadassah Medical Center in Jerusalem. We transform the cutting-edge research coming out of Hadassah into marketable medical technologies. We turn ground-breaking ideas into viable products and services that can change the world and better humanity.

NeuroGenesiscontact:Tsipi HaitovskyGlobal Media LiaisonNeuroGenesis+972-52-5989-892[emailprotected]

Hadassah contact:Hadar ElboimspokeswomanHadassah Medical Organization+ 972- 2-6776079[emailprotected]

SOURCE NeuroGenesis

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Hadassah Medical Center and Neurogenesis Announce Groundbreaking Results from a Phase 2 Study in Progressive Multiple Sclerosis treated with NG-01...

Recommendation and review posted by Bethany Smith

The following article features coverage from the ASH 2020 virtual meeting. Click here to read more of Oncology Nurse Advisors conference coverage.

Patients who received venetoclax with azacytidine for the treatment of higher-risk myelodysplastic syndrome (HR-MDS) had high overall survival rates and clinically meaningful improvements of dyspnea and fatigue through 48 weeks. These findings were presented during the American Society of Hematology (ASH) 62nd Annual Meeting and Exposition.

Jacqueline S. Garcia, MD, coauthor of this study, explained the mechanism of this therapy. Apoptosis is normally under tight control by the interaction between pro-survival and pro-biotic proteins. In HR-MDS, myeloblasts overexpress BCL-2 and blasts are generally highly prone to pro-apoptotic proteins. Azacytidine indirectly decreases other apoptotic proteins, which sensitizes cells to venetoclax. Venetoclax is a BCL-2 inhibitor, which induces death. Thus, these drugs have the potential to irreversibly commit the cell to death.

Patients (N=78) with HR-MDS who were not candidates for intensive chemotherapy were recruited for this ongoing, open-label, dose-escalation, phase 1b study. Study participants received venetoclax 400 or 800 mg for 28 days followed by an escalating dose (100, 200, and 400 mg) for 14 days in a 28-day cycle with azacitidine 75 mg/m2 subcutaneously or intravenously administered on the first 7 days of each cycle. Participants were assessed for adverse events and efficacy.

Patient group was 75% men, median age 71 years (range, 26 to 85) and 56% had very high-risk disease.

Of the 31 patients with baseline marrow data, the most frequent mutations were located in tumor protein p53 (TP53; 35.5%), additional sex combs like 1 (ASXL1; 19.4%), and stromal antigen 2 (STAG2; 16.1%).

All participants experienced at least 1 adverse event during the study. The most commonly observed events were constipation (54%), nausea (55%), and neutropenia (83%). Adverse events grade 3 or higher were experienced by 96% of patients and included febrile neutropenia (49%) and thrombocytopenia (42%). Few infections were observed, likely due to the antibiotic prophylaxis.

At 30 days, the mortality rate was 1% and 1.3% experienced disease progression. A total of 16 patients received post-study transplants (bone marrow, 7 patients; stem cell, 9 patients).

The objective response rate was 79%; in which 39.7% entered into complete remission, 39.7% into marrow complete remission, and 14.1% had stable disease.

The median duration of response was 12.9 months (range, 12.1 to 16.8), and among those who achieved complete remission, the median duration of response after remission was 13.8 months (range, 6.5 to 20.9). The median time to complete remission was 2.6 months (range, 1.2 to 19.6).

Physical function through 48 weeks was generally maintained and fatigue, dyspnea, and global health quality of life were improved among patients who received 400 mg of venetoclax for 14 days.

This study was limited by its small sample size and short duration; however, this study was still on-going, and a phase 3 trial has begun.

These results indicated venetoclax with azacitidine was efficacious, allowing for maintenance of physical functioning for up to 48 weeks among patients with HR-MDS who were not candidates for intensive chemotherapy.

Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.

Reference

Garcia JS, Wei AH, Borate U, et al. Safety, efficacy, and patient-reported outcomes of venetoclax in combination with azacitidine for the treatment of patients with higher-risk myelodysplastic syndrome: a phase 1b study. Presented at: American Society of Hematology (ASH) 62nd Annual Meeting and Exposition; December 5-8, 2020. Abstr 656.

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Venetoclax/Azacitidine Combination Efficacious for the Treatment of Older Patients With Higher-Risk Myelodysplastic Syndrome - Oncology Nurse Advisor

Recommendation and review posted by Bethany Smith

NEW YORK--(BUSINESS WIRE)--Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT) (Rocket), a clinical-stage company advancing an integrated and sustainable pipeline of genetic therapies for rare childhood disorders, today presents updated interim data from its Fanconi Anemia (FA) and Leukocyte Adhesion Deficiency-I (LAD-I) programs at the 62nd American Society of Hematology (ASH) Annual Meeting. The data are highlighted in two oral presentations.

We are highly pleased with the data presented at ASH demonstrating ongoing evidence of efficacy and durability using Process B in both FA and LAD-I as we move towards potential registration, said Gaurav Shah, M.D., Chief Executive Officer and President of Rocket. Follow-up data from the Phase 1 and 2 trials for FA continue to support RP-L102 as a potential hematologic treatment option in the absence of cytotoxic conditioning. In five of the seven patients treated as of October 2020, there was evidence of engraftment. In addition, stabilization of peripheral blood counts in two of the three patients with at least 12-month follow-up, which declined substantially in these patients prior to gene therapy, suggests a halt in bone marrow failure progression. We look forward to reporting longer-term follow-up on these patients in the first half of 2021.

Dr. Shah continued, Additionally, we continue to see encouraging evidence of efficacy for RP-L201 for the treatment of LAD-I. Patients have shown sustained CD18 expression of 23% to 40%, far exceeding the 4-10% threshold associated with survival into adulthood. These data, on top of our exciting results from our lentiviral program for PKD, show our steady progress across three of our five gene therapy programs. We are proud of this progress and are committed to advancing our investigational gene therapies through development for patients and families facing these devastating disorders.

Key findings and details for each presentation are highlighted below. To access the presentations at the conclusion of the oral presentation, please visit: https://www.rocketpharma.com/ash-presentations/

Gene Therapy for Fanconi Anemia, Complementation Group A: Updated Results from Ongoing Global Clinical Studies of RP-L102The data presented in the oral presentation are from seven of the nine patients treated as of the cutoff date of October 2020 in both the U.S. Phase 1 and global Phase 2 studies of RP-L102 for FA. Seven patients had follow-up data of at least 2-months, and three of the seven patients had been followed for 12-months or longer. Key highlights from the presentation include:

Presentation Details:Title: Gene Therapy for Fanconi Anemia, Complementation Group A: Updated Results from Ongoing Global Clinical Studies of RP-L102Session Title: Gene Editing, Therapy and Transfer IPresenter: Agnieszka Czechowicz, M.D., Ph.D., Assistant Professor of Pediatrics, Division of Stem Cell Transplantation, Stanford University School of MedicineSession Date: Monday, December 7, 2020Session Time: 11:30 a.m. - 1:00 p.m. (Pacific Time)Presentation Time: 12:15 p.m. (Pacific Time)

Phase 1/2 Study of Lentiviral-Mediated Ex-Vivo Gene Therapy for Pediatric Patients with Severe Leukocyte Adhesion Deficiency-I (LAD-I): Results from Phase 1The data presented in the oral presentation are from three pediatric patients with severe LAD-I, as defined by CD18 expression of less than 2%. The patients were treated with RP-L201, Rockets ex-vivo lentiviral gene therapy candidate. Patient L201-003-1001 was 9-years of age at enrollment and had been followed for 12-months as of a cutoff date of November 2020. Patient L201-003-1004 was 3-years of age at enrollment and had been followed for over 6-months. Patient L201-003-2006 was 7-months of age at enrollment and was recently treated with RP-L201. Key highlights from the presentation include:

Rockets LAD-I research is made possible by a grant from the California Institute for Regenerative Medicine (Grant Number CLIN2-11480). The contents of this press release are solely the responsibility of Rocket and do not necessarily represent the official views of CIRM or any other agency of the State of California.

Presentation Details:Title: Phase 1/2 Study of Lentiviral-Mediated Ex-Vivo Gene Therapy for Pediatric Patients with Severe Leukocyte Adhesion Deficiency-I (LAD-I): Results from Phase 1Session Title: Gene Editing, Therapy and Transfer IPresenter: Donald Kohn, M.D., Professor of Microbiology, Immunology and Molecular Genetics, Pediatrics (Hematology/Oncology), Molecular and Medical Pharmacology, and member of the Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research at the University of California, Los AngelesSession Date: Monday, December 7, 2020Session Time: 11:30 a.m. - 1:00 p.m. (Pacific Time)Presentation Time: 12:30 p.m. (Pacific Time)

Conference Call DetailsRocket management will host a conference call and webcast today December 7, at 6:00 p.m. EST. To access the call and webcast, please click here. The webcast replay will be available on the Rocket website following the completion of the call.

Investors may listen to the call by dialing (866) 866-1333 from locations in the United States or +1 (404) 260-1421 from outside the United States. Please refer to conference ID number 50038102

About Fanconi AnemiaFanconi Anemia (FA) is a rare pediatric disease characterized by bone marrow failure, malformations and cancer predisposition. The primary cause of death among patients with FA is bone marrow failure, which typically occurs during the first decade of life. Allogeneic hematopoietic stem cell transplantation (HSCT), when available, corrects the hematologic component of FA, but requires myeloablative conditioning. Graft-versus-host disease, a known complication of allogeneic HSCT, is associated with an increased risk of solid tumors, mainly squamous cell carcinomas of the head and neck region. Approximately 60-70% of patients with FA have a Fanconi Anemia complementation group A (FANCA) gene mutation, which encodes for a protein essential for DNA repair. Mutation in the FANCA gene leads to chromosomal breakage and increased sensitivity to oxidative and environmental stress. Increased sensitivity to DNA-alkylating agents such as mitomycin-C (MMC) or diepoxybutane (DEB) is a gold standard test for FA diagnosis. Somatic mosaicism occurs when there is a spontaneous correction of the mutated gene that can lead to stabilization or correction of a FA patients blood counts in the absence of any administered therapy. Somatic mosaicism, often referred to as natural gene therapy provides a strong rationale for the development of FA gene therapy because of the selective growth advantage of gene-corrected hematopoietic stem cells over FA cells.

About Leukocyte Adhesion Deficiency-ISevere Leukocyte Adhesion Deficiency-I (LAD-I) is a rare, autosomal recessive pediatric disease caused by mutations in the ITGB2 gene encoding for the beta-2 integrin component CD18. CD18 is a key protein that facilitates leukocyte adhesion and extravasation from blood vessels to combat infections. As a result, children with severe LAD-I are often affected immediately after birth. During infancy, they suffer from recurrent life-threatening bacterial and fungal infections that respond poorly to antibiotics and require frequent hospitalizations. Children who survive infancy experience recurrent severe infections including pneumonia, gingival ulcers, necrotic skin ulcers, and septicemia. Without a successful bone marrow transplant, mortality in patients with severe LAD-I is 60-75% prior to the age of 2 and survival beyond the age of 5 is uncommon. There is a high unmet medical need for patients with severe LAD-I.

About Rocket Pharmaceuticals, Inc.Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT) (Rocket) is advancing an integrated and sustainable pipeline of genetic therapies that correct the root cause of complex and rare childhood disorders. The companys platform-agnostic approach enables it to design the best therapy for each indication, creating potentially transformative options for patients afflicted with rare genetic diseases. Rocket's clinical programs using lentiviral vector (LVV)-based gene therapy are for the treatment of Fanconi Anemia (FA), a difficult to treat genetic disease that leads to bone marrow failure and potentially cancer, Leukocyte Adhesion Deficiency-I (LAD-I), a severe pediatric genetic disorder that causes recurrent and life-threatening infections which are frequently fatal, Pyruvate Kinase Deficiency (PKD) a rare, monogenic red blood cell disorder resulting in increased red cell destruction and mild to life-threatening anemia and Infantile Malignant Osteopetrosis (IMO), a bone marrow-derived disorder. Rockets first clinical program using adeno-associated virus (AAV)-based gene therapy is for Danon disease, a devastating, pediatric heart failure condition. For more information about Rocket, please visit http://www.rocketpharma.com.

Rocket Cautionary Statement Regarding Forward-Looking StatementsVarious statements in this release concerning Rocket's future expectations, plans and prospects, including without limitation, Rocket's expectations regarding its guidance for 2020 in light of COVID-19, the safety, effectiveness and timing of product candidates that Rocket may develop, to treat Fanconi Anemia (FA), Leukocyte Adhesion Deficiency-I (LAD-I), Pyruvate Kinase Deficiency (PKD), Infantile Malignant Osteopetrosis (IMO) and Danon Disease, and the safety, effectiveness and timing of related pre-clinical studies and clinical trials, may constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995 and other federal securities laws and are subject to substantial risks, uncertainties and assumptions. You should not place reliance on these forward-looking statements, which often include words such as "believe," "expect," "anticipate," "intend," "plan," "will give," "estimate," "seek," "will," "may," "suggest" or similar terms, variations of such terms or the negative of those terms. Although Rocket believes that the expectations reflected in the forward-looking statements are reasonable, Rocket cannot guarantee such outcomes. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, Rocket's ability to monitor the impact of COVID-19 on its business operations and take steps to ensure the safety of patients, families and employees, the interest from patients and families for participation in each of Rockets ongoing trials, our expectations regarding the delays and impact of COVID-19 on clinical sites, patient enrollment, trial timelines and data readouts, our expectations regarding our drug supply for our ongoing and anticipated trials, actions of regulatory agencies, which may affect the initiation, timing and progress of pre-clinical studies and clinical trials of its product candidates, Rocket's dependence on third parties for development, manufacture, marketing, sales and distribution of product candidates, the outcome of litigation, and unexpected expenditures, as well as those risks more fully discussed in the section entitled "Risk Factors" in Rocket's Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, filed November 6, 2020 with the SEC. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and Rocket undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

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Rocket Pharmaceuticals Presents Positive Clinical Data from its Fanconi Anemia and Leukocyte Adhesion Deficiency-I Programs at the 62nd American...

Recommendation and review posted by Bethany Smith

GERMANTOWN, Md., Dec. 7, 2020 /PRNewswire/ -- Precigen Inc., a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, today announced at the 62nd ASH Annual Meeting and Exposition (Abstract 2864) clinical progress and new data from the ongoing Phase 1/1b clinical study of PRGN-3006UltraCAR-Tin patients with relapsed or refractory (r/r) acute myeloid leukemia (AML) and higher risk myelodysplastic syndrome (MDS) (clinical trial identifier: NCT03927261).

AML is a rapidly progressing disease with poor prognosis and high unmet need. Precigen's UltraCAR-T platform is designed to overcome limitations of currently available chimeric antigen receptor (CAR)-T therapies by utilizing an advanced overnight non-viral gene delivery manufacturing process at a medical center's cGMP facility without the need for ex vivo expansion. Current CAR-T cell therapies are limited due to, inter alia, the prolonged interval between apheresis to product infusion and an exhausted phenotype of T cells resulting from lengthy ex vivo expansion. As announced in November 2020, UltraCAR-T cells for the PRGN-3006 study are now manufacturedovernight using Precigen's proprietary UltraPorator device. PRGN-3006 UltraCAR-T is a multigenic autologous CAR-T simultaneously expressing a CAR specifically targeting CD33; membrane bound IL-15 (mbIL15) for enhanced in vivo expansion and persistence; and a kill switch to conditionally eliminate CAR-T cells for an improved safety profile. CD33 is over-expressed on AML blasts with lesser expression on normal hematopoietic stem cells.

An investigator-initiated, non-randomized Phase 1/1b dose-escalation study to evaluate the safety and maximal tolerated dose of PRGN-3006 UltraCAR-T is currently ongoing in collaboration with the H. Lee Moffitt Cancer Center & Research Institute (Moffitt). The study population includes adult patients ( 18 years) with r/r AML and hypomethylating agent (HMA) failure, higher risk MDS or chronic myelomonocytic leukemia (CMML) patients with 5% blasts. To test the hypothesis that expression of mbIL15 on PRGN-3006 can promote UltraCAR-T cell expansion and persistence without the need for lymphodepletion and improve the overall safety profile, studysubjects receive the PRGN-3006 infusion either without prior lymphodepletion (Cohort 1) or following lymphodepleting chemotherapy (Cohort 2). A multicenter expansion of the trial is planned.

Key findings:

A case study of the patient with the longest follow-up as of the data cutoff was also presented. This patient received, one day after gene transfer and without prior lymphodepletion, a very low dose, approximately three hundred thousand UltraCAR-T per kilogram (3 x 105 UltraCAR-T/kg) for a total of only 24 million UltraCAR-T. She is a 69 year old female with secondary AML (sAML) and four prior lines of therapy, including induction chemotherapy (IC), allogenic hematopoietic stem cell transplantation (allo-HSCT), HMA plus venetoclax (HMA+VEN), refractory to all therapy post allo-HSCT. The patient had approximately 40% peripheral blasts and 47% bone marrow blasts at baseline.

Case study findings:

"There is an urgent need for novel therapies for relapsed or refractory AML patients as the median overall survival for this patient population is less than six months. Current CAR-T approaches for AML have faced challenges due to long manufacturing durations resulting in subsequent delays in treatment," said David A. Sallman, MD, of Moffitt and lead investigator for the PRGN-3006 clinical study. "We are encouraged by the initial data, including safety and manufacturing success from patients treated with autologous UltraCAR-T cells, which were manufactured on-site with almost instant turnaround. We are excited by the expansion and continued persistence of PRGN-3006 UltraCAR-T cells in the patient case study for over seven months post-infusion without prior lymphodepletion and are looking forward to higher doses in the lymphodepleted and non-lymphodepletion cohorts."

"Currently commercialized CAR-T therapies have not demonstrated the persistence needed to drive sustained, durable responses," said Helen Sabzevari, PhD, President and CEO of Precigen. "The results from Dr. Sallman's patient case study are particularly encouraging as the patient received a very low dose of cells without any ex vivo expansion or activation and no lymphodepletion, which highlights the importance of membrane bound IL-15 in expansion and persistence of these cells and, we believe, differentiates the UltraCAR-T platform from other CAR-T's. In particular, expansion and persistence of UltraCAR-T cells in the patient's blood through seven months post-infusion show promise for the durability of PRGN-3006. We look forward to providing additional details for the PRGN-3006 study at our upcoming clinical update call this month."

About Acute Myeloid Leukemia (AML)AML is a cancer that starts in the bone marrow, but most often moves into the blood.1 Though consideredrare, AML is among the most common types of leukemia in adults.2 In 2019, it was estimated that 21,450 new cases of AML would be diagnosed in the US.2 AML is uncommon before the age of 45 and the average age of diagnosis is about 68.2 The prognosis for patients with AML is poor with an average 5year survival rate of approximately 25 percent overall, and less than a 5 percent 5year survival rate for patients older than 65.3 Amongst elderly AML patients ( 65 years of age), median survival isshort, ranging from 3.5 months for patients 65 to 74 years of age to 1.4 months for patients 85 years of age.3

About Myelodysplastic Syndrome (MDS)MDS are diseases of the bone marrow generally found in adults in their 70s.4 Incidence in the US is not known for sure, but estimates range from 10,000 each year and higher.4 Using International Prognostic Scoring System (IPSS-R), median survival for MDS patients can vary from less than one year for the "very high" IPSS-R risk group to more than eight years for the "very low" IPSS-R group.4

About PRGN-3006 UltraCAR-TPRGN-3006 UltraCAR-T is a multigenic autologous CAR-T cell treatment utilizing Precigen's non-viral Sleeping Beauty system to simultaneously express a CAR specifically targeting CD33, which is over expressed on acute myeloid leukemia blasts with lesser expression on normal hematopoietic stem cell populations and minimal non-hematopoietic expression; membrane bound IL-15 for enhanced in vivo expansion and persistence; and a kill switch to conditionally eliminate CAR-T cells for animproved safety profile. PRGN-3006 is being evaluated in collaboration with the Moffitt Cancer Center in a nonrandomized, investigatorinitiated Phase 1/1b dose escalation study to evaluate the safety and maximal tolerated dose of PRGN3006 UltraCAR-T (clinical trial identifier: NCT03927261). The study population includes patients with relapsed or refractory acute myeloid leukemia or higher risk myelodysplastic syndrome. The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) for PRGN-3006 UltraCAR-T in patients with AML.

Precigen: Advancing Medicine with PrecisionPrecigen (Nasdaq: PGEN) is a dedicated discovery and clinical stage biopharmaceutical company advancing the next generation of gene and cell therapies using precision technology to target urgent and intractable diseases in our core therapeutic areas of immuno-oncology, autoimmune disorders, and infectious diseases. Our technologies enable us to find innovative solutions for affordable biotherapeutics in a controlled manner. Precigen operates as an innovation engine progressing a preclinical and clinical pipeline of well-differentiated unique therapies toward clinical proof-of-concept and commercialization. For more information about Precigen, visit http://www.precigen.com or follow us on Twitter @Precigen and LinkedIn.

TrademarksPrecigen, UltraCAR-T, UltraPorator and Advancing Medicine with Precision are trademarks of Precigen and/or its affiliates. Other names may be trademarks of their respective owners.

Cautionary Statement Regarding Forward-Looking StatementsSome of the statements made in this press release are forward-looking statements. These forward-looking statements are based upon the Company's current expectations and projections about future events and generally relate to plans, objectives, and expectations for the development of the Company's business, including the timing and progress of preclinical studies, clinical trials, discovery programs and related milestones, the promise of the Company's portfolio of therapies, and in particular its CAR-T therapies, and the Company's refocus to a healthcare-oriented business. Although management believes that the plans and objectives reflected in or suggested by these forward-looking statements are reasonable, all forward-looking statements involve risks and uncertainties, including the possibility that the timeline for the Company's clinical trials might be impacted by the COVID-19 pandemic, and actual future results may be materially different from the plans, objectives and expectations expressed in this press release. The Company has no obligation to provide any updates to these forward-looking statements even if its expectations change. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. For further information on potential risks and uncertainties, and other important factors, any of which could cause the Company's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in the Company's most recent Annual Report on Form 10-K and subsequent reports filed with the Securities and Exchange Commission.

References1 American Cancer Society. What is Acute Myeloid Leukemia (AML)?2 American Cancer Society. Key Statistics for Acute Myeloid Leukemia (AML)3 Thein, M., et al., Outcome of older patients with acute myeloid leukemia: an analysis of SEER data over 3 decades. Cancer, 2013. 119(15): p.2720-74 American Cancer Society.Key Statistics for Myelodysplastic Syndromes

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Precigen Presents New Data Supporting the Safety, Clinical Activity, Expansion and Persistence of PRGN-3006 UltraCAR-T at the 62nd ASH Annual Meeting...

Recommendation and review posted by Bethany Smith

NEW YORK, Dec. 10, 2020 (GLOBE NEWSWIRE) -- BeyondSpring (the Company or BeyondSpring) (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, today announced the new data from its Phase 3 PROTECTIVE-2 Study 106 demonstrating that plinabulin in combination with pegfilgrastim offers greater protection against chemotherapy-induced neutropenia (CIN) than the standard of care, pegfilgrastim alone. The study not only met the primary and key secondary objectives, as previously disclosed on Nov. 16, 2020, but also demonstrated that the combination was 53% more effective than pegfilgrastim alone in reducing the incidence of profound neutropenia (absolute neutrophil count or ANC < 0.1 x 10E9 cells/L), 21.6% vs. 46.4%, respectively, p=0.0001, in patients with breast cancer undergoing chemotherapy with TAC (docetaxel, doxorubicin, and cyclophosphamide). Profound neutropenia (PN) is a well-known risk factor to increase the rates of infection, febrile neutropenia (FN), and hospitalization among patients undergoing chemotherapy. Of clinical importance, the combination has shown to reduce the odds of having FN by 41% in comparison to pegfilgrastim, based on reduction of profound neutropenia.

It is clinically meaningful to reduce FN risk by 41% in the combination, compared to pegfilgrastim alone, which is the only major breakthrough advancement in CIN prevention in the last 30 years. The CIN protection from plinabulin added to pegfilgrastim, particularly in the first week of chemotherapy when 75% of CIN-related complications occur before the effect of pegfilgrastim kicks-in in Week 2, fills the treatment gap in current standard of care, said Douglas Blayney, M.D., Professor of Medicine at Stanford Medical School, and global PI for the plinabulin CIN studies. The combination of plinabulin with pegfilgrastim represents a major advancement in offering protection against CIN, with the potential to reduce FN risk, in the care of cancer patients.

The data were presented via a poster at the 2020 San Antonio Breast Cancer Symposium (SABCS): Superior and Clinically Meaningful Protection Against Profound Neutropenia with the Plinabulin/Pegfilgrastim (Plin/Peg) Combination versus Peg In Breast Cancer Patients ReceivingTAC Chemotherapy. Profound neutropenia, an exploratory endpoint representing the most severe form of CIN, is associated with significant risk to patients and may require antibacterial or antifungal prophylaxis [Flowers JCO 2013]. It is attributed to both febrile neutropenia (48%) and infection (50%) [Bodey Cancer 1978]. In BeyondSprings PROTECTIVE-2 studies, patients with profound neutropenia had close to nine times the risk of FN compared to patients with no profound neutropenia. The new data presented at SABCS included:

This trial is a global, multicenter, randomized, double-blinded study in patients with breast cancer undergoing myelosuppressive chemotherapy with TAC (docetaxel at 75 mg/m2, doxorubicin at 50 mg/m2, and cyclophosphamide at 500 mg/m2) for the evaluation of protection against CIN, comparing plinabulin (40 mg) in combination with pegfilgrastim (6 mg) in 111 patients to pegfilgrastim alone (6 mg) in 110 patients. On Day 1, they received TAC and plinabulin or placebo, and on Day 2, they received pegfilgrastim. Topline data from the Protective-2 Phase 3 trial were reported on November 16, 2020 highlighting that the study met its primary endpoint as well as key secondary endpoints.

It is well recognized that CIN is directly related to chemotherapys ability to kill rapidly dividing cells. Unfortunately, fast dividing neutrophils in the bone marrow are adversely affected regardless of the chemotherapy type. As a result, we believe these outcomes are universally applicable to any chemotherapy, and are independent of cancer types, added Gordon Schooley, Ph.D., BeyondSprings Chief Regulatory Officer. As both the U.S. FDA and China NMPA recently awarded BeyondSprings Plinabulin CIN program with Breakthrough Therapy Designation status based on the interim phase 3 data of PROTECTIVE-2, and the Company now completing the PROTECTIVE-2 trial with positive and consistent results to the interim, we are well on track to submit our NDA for CIN in Q1 2021. The improved CIN prevention benefit of the Plinabulin/G-CSF combination would have the potential for CIN prevention of the myelosuppressive effects of different chemotherapeutic agents in millions of patients with multiple tumor types.

Ramon Mohanlal, M.D., Ph.D., BeyondSprings Chief Medical Officer and Executive Vice President, Research and Development concluded, Plinabulin represents a new treatment paradigm for CIN prevention, an area wherein G-CSF has established efficacy, but with short-comings due to its delayed onset of action, next day dosing requirement, bone pain induction, and platelet count reduction. Plinabulin has a fast onset mechanism of action, without causing relevant bone pain or thrombocytopenia, and can be given on the same day as chemotherapy. Plinabulin added to G-CSF offers superior prevention of CIN, and has the potential to avoid life-threatening infections and to improve short-term and long-term survival. Plinabulins anticancer activity from its immune-enhancing mechanism of action, together with its CIN preventive effects, has the potential to become a universal add-on to anti-cancer treatments in general.

The above data are available on BeyondSpringswebsite in the Posters section.

About PlinabulinPlinabulin, BeyondSprings lead asset, is a differentiated immune and stem cell modulator. Plinabulin is currently in late-stage clinical development to increase overall survival in cancer patients, as well as to alleviate chemotherapy-induced neutropenia (CIN). The durable anticancer benefits of Plinabulin have been associated with its effect as a potent antigen-presenting cell (APC) inducer (through dendritic cell maturation) and T-cell activation (Chem and Cell Reports, 2019). Plinabulins CIN data highlight the ability to boost the number of hematopoietic stem / progenitor cells (HSPCs), or lineage-/cKit+/Sca1+ (LSK) cells in mice. Effects on HSPCs could explain the ability of Plinabulin not only to treat CIN, but also to reduce chemotherapy-induced thrombocytopenia and increase circulating CD34+ cells in patients.

About CINPatients receiving chemotherapy typically develop chemotherapy-induced neutropenia (CIN), a severe side effect that increases the risk of infection with fever (also called febrile neutropenia, or FN), which necessitates ER/hospital visits. The updated National Comprehensive Cancer Network (NCCN) guidelines expanded the use of prophylactic G-CSFs, such as pegfilgrastim, to include not only high- risk patients (chemo FN rate>20%), but also intermediate-risk patients (FN rate between 10-20%) to avoid hospital/ER visits during the COVID-19 pandemic. The revision of the NCCN guidelines effectively doubles the addressable market of patients who may benefit from treatment with plinabulin, if approved, to approximately 440,000 cancer patients in the U.S. annually. Plinabulin is designed to provide protection against the occurrence of CIN and its clinical consequences in week 1, for early onset of action after chemotherapy. CIN is the primary dose-limiting toxicity in cancer patients who receive chemotherapy treatment.

About BeyondSpringBeyondSpring is a global, clinical-stage biopharmaceutical company focused on the development of innovative cancer therapies. BeyondSprings lead asset, plinabulin, a first-in-class agent as an immune and stem cell modulator, is in a Phase 3 global clinical trial as a direct anticancer agent in the treatment of non-small cell lung cancer (NSCLC) and Phase 3 clinical programs in the prevention of CIN. The U.S. FDA granted Breakthrough Therapy designation to plinabulin for concurrent administration with myelosuppressive chemotherapeutic regimens in patients with non-myeloid malignancies for the prevention of chemotherapy-induced neutropenia (CIN). BeyondSpring has strong R&D capabilities with a robust pipeline in addition to plinabulin, including three immuno-oncology assets and a drug discovery platform using the protein degradation pathway, which is being developed in a subsidiary company, Seed Therapeutics, Inc. The Company also has a seasoned management team with many years of experience bringing drugs to the global market. BeyondSpring is headquartered in New York City.

Cautionary Note Regarding Forward-Looking StatementsThis press release includes forward-looking statements that are not historical facts. Words such as "will," "expect," "anticipate," "plan," "believe," "design," "may," "future," "estimate," "predict," "objective," "goal," or variations thereof and variations of such words and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are based on BeyondSpring's current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, difficulties raising the anticipated amount needed to finance the Company's future operations on terms acceptable to the Company, if at all, unexpected results of clinical trials, delays or denial in regulatory approval process, results that do not meet our expectations regarding the potential safety, the ultimate efficacy or clinical utility of our product candidates, increased competition in the market, and other risks described in BeyondSprings most recent Form 20-F on file with the U.S. Securities and Exchange Commission. All forward-looking statements made herein speak only as of the date of this release and BeyondSpring undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.

Media Contacts

Investor Contact:Ashley R. RobinsonLifeSci Advisors, LLC+1 617-430-7577arr@lifesciadvisors.com

Media Contact:Darren Opland, Ph.D.LifeSci Communications+1 646-627-8387darren@lifescicomms.com

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BeyondSpring Announces New Positive PROTECTIVE-2 Phase 3 Registrational Trial Results at the 2020 San Antonio Breast Cancer Symposium - BioSpace

Recommendation and review posted by Bethany Smith

Thats how Valerie Mitchell of Joliet is expressing the pre-holiday news that her son Owen Buell, 2, is showing no evidence of disease in regards to the neuroblastoma hes been fighting all year.

We are really happy, Mitchell said. I still cannot believe he is cancer-free. Everyone is really overjoyed about it, especially being around Christmastime.

On Friday, Owen had a number of scans including CT MRI, MIBG and an echocardiogram, along with bone marrow and hearing tests. Mitchell said. All scans came back clear, she said.

He fought as hard as he could and beat cancer, Mitchell said.

But Owen must remain cancer-free for the next five years before the word remission can be used, she said. In addition, Owen also has more treatments ahead of him: six months of immunotherapy, which Mitchell said will be extremely painful and hard on the body.

Owen will need a five to six-day stay in the hospital each month and a pain pump just to receive the treatments, Mitchell said. But the treatment is necessary to eliminate any remaining cancer cells in Owens body; otherwise new tumors or spots of cancer may form.

Were all really tired, Mitchell said. But we can push through knowing that hes going to be cancer-free. Its just one more step and then he should be good.

When Owen was diagnosed in February, he had two tumors and 21 spots of cancer, Mitchell said. His father Brian was working a job and a half at the time and he and Mitchell shared the family van.

Since then, Owen has undergone many scans, a central line placement, five rounds of chemotherapy, surgery to remove tumors, a stem cell harvest, two stem cell transplants that required a three-month hospital stay, 12 rounds of radiation and 10 days of being intubated in the hospitals intensive care unit, Mitchell said.

Owen now also has damage to one kidney and high blood pressure, Mitchell said. The COVID-19 pandemic made treatments even harder on Owen and his family, she added, especially since Owen's brothers Elliott and Bentley, age 4.were just 7 and 4 when Owen was diagnosed.

We didn't have the help everyone was offering in fear Owen would catch this virus, Mitchell wrote on her Facebook page. We couldn't go anywhere in between treatment to cheer Owen up. We couldn't bring him into the store to pick out a new toy or get him out of the house. He couldn't go swimming; he couldn't go to any arcades; he couldn't even have his father or siblings by his side undergoing surgery or chemo. It wasn't/ isnt fair that Owen had to suffer as much as he did. But we are happy he is still here.

Mitchell said the family celebrated Owens good news with pizza, cake and silly string. And she said Owen is going to go crazy with happiness when he sees all the Christmas gifts toys theyve bought for him.

In the meantime, Owen is enjoying the holiday season like any other 2-year-old.

Hes already playing with the Christmas tree bulbs, Mitchell said.

Donate to the "Help for baby Owen Buell and his Family" GoFundMe page at bit.ly/3n0MThy.

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Joliet 2-year-old gets pre-holiday gift: tests that show he's cancer-free - The Herald-News

Recommendation and review posted by Bethany Smith

GAITHERSBURG, Md., Dec. 07, 2020 (GLOBE NEWSWIRE) -- NexImmune, a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to employ the bodys own T cells to generate a specific, potent and durable immune response that mimics natural biology, today announced that City of Hopes Monzr Al Malki, M.D., delivered an oral presentation at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition featuring initial data from the Phase 1/2 trial of NEXI-001 in AML. Entitled Preliminary Results of the First-in-Human Study of NEXI-001, a Multi-Antigen Specific CD8+ T Cell Product, in Acute Myeloid Leukemia (AML) Patients with Relapsed Disease after Allogeneic Hematopoietic Cell Transplantation (Allo-HSCT) Demonstrate Early Signs of Safety, Tolerability and Robust Immune Responses, the presentation included responses following a single infusion of the experimental therapy.

These data represent safety and tolerability results from the first five patients treated and reflect a median of four months of follow-up with infusion doses ranging from 50-200 million total T cells. As noted by Dr. Al Malki in his presentation, there have been no cases of acute Graft versus Host Disease (aGvHD), Cytokine Release Syndrome (CRS), immune cells-associated neurological syndromes (ICANs), or infusion related reactions (IRRs) reported to-date, nor have there been any treatment-related adverse events (AEs) observed.

Biomarker data characterizing initial immunologic responses for the first three patients analyzed were also shared. Absolute lymphocyte counts, or ALC, were followed over time after the administration of lymphodepleting therapy, and showed a rapid return to baseline levels for each patient assessed (range 3 to 35 days). In addition, data on T cell reconstitution after lymphodepletion demonstrated that a single infusion of NEXI-001 T cells triggered a broad, rapid and robust immune response, inclusive of both CD8+ and CD4+ T cell types. TCR analysis showed the presence, persistence, expansion and migration of individual NEXI-001 T cell clones from the peripheral blood to the bone marrow of each patient. Finally, the immune phenotype of individual T cell subtypes in each NEXI-001 product were maintained in the peripheral blood of each patient at all time points measured, up to two months. These included sustained populations of T stem-cell-like memory and T central memory subtypes.

Early results from this Phase 1/2 trial suggest that infusion of the NEXI-001 product is well-tolerated and capable of triggering early, robust and persistent cell-mediated immune responses, said Dr. Al Malki, the trials lead investigator and associate clinical professor in City of Hopes Department of Hematology & Hematopoietic Cell Transplantation. The initial data are encouraging, and we look forward to dosing more patients with longer follow-up in order to more fully characterize the clinical potential of this exciting new cell therapy.

Relapse after allo-HSCT is the leading cause of death in patients with AML and represents a significant challenge for treating physicians. There are no approved therapies, and current treatment options are limited. Donor lymphocyte infusions (DLIs) represent the current standard of care but are associated with modest Graft versus Leukemia (GvL) responses and high rates of life-threatening GvHD-associated toxicities. There is significant need for new cellular therapies with potential to enhance the benefits of GvL while decreasing the incidence of GvHD-related toxicities.

Han Myint, M.D., Chief Medical Officer at NexImmune, added, While still early in this trial, we believe the initial data reported, combined with the unique and consistent composition of each NEXI-001 product, may offer a cell therapy with potential to decouple the benefits of GvL from the toxicities associated with GvHD, which would be transformative for both allogeneic stem cell transplant patients and the physicians that provide care for them.

About the Phase 1/2 NEXI-001 Clinical TrialThe first clinical trial with NEXI-001 is a prospective, multi-center, open-label, single-arm, dose-escalating Phase 1/2 study that aims to enroll between 22 to 28 patients. The primary objective is to assess the safety and tolerability of a single infusion of NEXI-001 T cells in patients with AML who have either minimum residual disease (MRD) or relapsed disease after a human leukocyte antigen (HLA)-matched allo-HSCT. Secondary objectives include signals of immunologic responses and preliminary anti-tumor activity. Additional analysis will assess the in vivo persistence, proliferation, functionality and TCR repertoire of NEXI-001 T cells as measured in blood and bone marrow samples.

This study includes two phases. The initial Safety Evaluation Phase determines the safety and tolerability of a single infusion of NEXI-001 at escalating dose levels. In the second part of the study, the Dose Expansion Phase, investigators further define safety and will also evaluate the initial efficacy of NEXI-001 T cells at the dose established in the Safety Evaluation Phase. Once a Recommended Phase II Dose has been determined, safety, tolerability and initial clinical response will become the objectives of the expansion phase of the trial, which is expected to begin in [the first quarter] of 2021.

NEXI-001 products contain populations of CD8+ T cells directed against HLA 02.01-restricted peptides from the WT1, PRAME and Cyclin A1 antigens, each of which is commonly over-expressed on AML blasts and leukemic stem cells. Each NEXI-001 product is composed of T cell memory subtypes that combine anti-tumor potency with long-term persistence. Of significance to this Phase 1/2 trial, each patient-specific experimental cell therapy product also contains very low proportions of T cell subtypes with potential to cause GvHD-related toxicities.

About NexImmuneNexImmune is a clinical-stage biotechnology company developing unique approaches to T cell immunotherapies based on its proprietary Artificial Immune Modulation (AIM) technology. The AIM technology is designed to generate a targeted T cell-mediated immune response and is initially being developed as a cell therapy for the treatment of hematologic malignancies. AIM nanoparticles act as synthetic dendritic cells to deliver immune-specific signals to targeted T cells and can direct the activation or suppression of cell-mediated immunity. In cancer, AIM-expanded T cells have demonstrated best-in-class anti-tumor properties as characterized by in vitro analysis, including a unique combination of anti-tumor potency, antigen target-specific killing, and long-term T cell persistence. The modular design of the AIM platform enables rapid expansion across multiple therapeutic areas, with both cell therapy and injectable products.

NexImmunes two lead T cell therapy programs, NEXI-001 and NEXI-002, are in Phase 1/2 clinical trials for the treatment of relapsed AML after allo-HSCT and multiple myeloma refractory to at least three prior lines of therapy, respectively. The Companys pipeline also has additional preclinical programs, including cell therapy and injectable product candidates for the treatment of solid tumors, autoimmune disorders and infectious diseases.

For more information, visit http://www.neximmune.com.

Media Contact:Mike BeyerSam Brown Inc. Healthcare Communications312-961-2502mikebeyer@sambrown.com

Investor Contact:Chad RubinSolebury Trout+1-646-378-2947crubin@soleburytrout.com

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Preliminary Results from NexImmune's Phase 1/2 Trial of NEXI-001 in AML Presented at 62nd ASH Annual Meeting and Exposition - GlobeNewswire

Recommendation and review posted by Bethany Smith

Were all familiar with the usual culprits that lead to skin aging, like not wearing a daily SPF, smoking, lack of hydration, genetics, stress, etc. But in the realm of internal and external factors that can zap your skin of its youthful bounce and glow, theres one important factor that isnt discussed nearly enough: inflammation.

While you might think of this condition only as it relates to a sprained ankle or a particularly aggressive zit, inflammation actually touches our daily lives in a multitude of ways. Its the result of those well-known aging factors (again, like stress and UV rays), but its not always a singular response, like redness or irritation. Says board-certified dermatologist Dr. Joshua Zeichner, Inflammation leads to free-radical damage in the skin, activation of matrix metalloproteinases, and [recruitment of] inflammatory blood cells. Collectively, this leads to damage to skin cells themselves along with destruction of supporting tissue like collagen and elastin. This explains why chronic inflammation can lead to weakening of the skin, premature wrinkling, and sagging.

Brands are starting to take note of how inflammation plays a central role in the aging process, particularly as it relates to the look and feel of our skin, and have dubbed this sequence of events as inflammaging. The beauty industry loves a trendy marketing term, sure, but in this case, there is some real data to back it up.

As Amir Nobakht, MD, MBA, and co-founder of Heraux, explains, Inflammation is supposed to be a temporary response to stress, activating stem cells to regenerate the skin after stress and injuries. However, if inflammation persists, the increased burden on stem cells accelerates the aging process as they are constantly in overdrive. This link between chronic inflammation and aging is referred to as inflammaging.

Together with his business partner Ben Van Handel, PhD, and a stem cell biologist at the University of Southern California, they founded their brand Heraux (which consists of a singular targeted serum with their proprietary molecule, HX-1) to address the signs and symptoms of this detrimental process and modulate the inflammatory pathway in the skin. Full disclosure: This editor has used their serum for as long as its been available, with no plans to stop anytime soon.

So why is this inflammation issue notable if you already know that things like smoking and tanning are bad for you? Well, unfortunately, inflammation is a rather stealthy foe, which can pop up in your skin without any visible indication that its happening. Dr. Nobakht emphasizes, Once [inflammation] is visible on the skin, that indicates a more severe response. This can include redness, rough texture, irritation, and even a burning sensation (think post-sunburn). Again, your skin is experiencing inflammation by its very nature as a barrier between the external and internal in our body. Inflammaging occurs when your skins ability to buffer inflammation is exceeded by the stressors present.

Essentially, the aging process is a slow, silent onethis we knowbut is exacerbated and accelerated by all the choices we make and the inflammatory responses they generate. Once your skin has weathered years and years of this type of inflammation, your defenses are weakened, and those signs of aging, like fine lines, hyperpigmentation, and sagging, inevitably appear.

As bleak as this may sound, there are things you can do to help slow the overall inflammaging progression and prevent premature signs of skin aging. Dr. Zeichner recommends a healthy lifestyle with a balanced diet and plenty of exercise to start, followed by a skin-care routine that incorporates daily sunscreen, gentle cleansers, antioxidant-rich products (think of antioxidants like fire extinguishers that put out inflammation caused by free radicals), a generous helping of moisturizer (particularly at night), and products that promote collagen production like retinoids and bakuchiol.

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How to Minimize Inflammation and Prevent Your Skin from Inflammaging - Coveteur

Recommendation and review posted by Bethany Smith

Dec. 8, 2020 16:00 UTC

DUARTE, Calif.--(BUSINESS WIRE)-- City of Hope doctors participated in research presented at the American Society of Hematology (ASH) virtual meeting, Dec. 5 to 8, that are helping advance the treatment of blood cancers, including one study which demonstrated allogeneic stem cell transplants do have a survival benefit for older adults with myelodysplastic syndromes (MDS) compared with current standard of care.

The study is the largest and most definitive trial to demonstrate the benefits of an allogeneic stem cell transplantation for older adults with MDS, and is just one of numerous studies that City of Hope doctors help lead with the aim of finding more effective treatments of various blood cancers.

This years ASH conference truly showcases City of Hopes leadership in finding more effective treatments for blood cancers, said Stephen J. Forman, M.D., director of City of Hopes Hematologic Malignancies Research Institute. Whether its finding innovative treatments to make it possible for more older adults with cancer to receive stem cell transplants, or pursuing therapies that are more effective with fewer side effects, City of Hope doctors continue to lead innovative research in blood cancers and other hematological malignancies.

City of Hope doctors are leading novel clinical trials for patients with leukemia, lymphoma and other blood cancers.

Multicenter clinical trial led by City of Hope makes stem cell transplant possible for older adults with myelodysplastic syndromes

Allogeneic hematopoietic cell transplantation, or stem cell/bone marrow transplants, for blood cancers that have recurred or are difficult to treat can put the disease into long-term remission and provide a potential cure. The therapy establishes a new, disease-free blood and immune system by transplanting healthy blood stem cells from a donor into a cancer patient after destroying the patients unhealthy bone marrow.

City of Hope and other institutions started this therapy in 1976, primarily for younger patients with blood cancers. The therapy involves using high-dose chemotherapy and/or radiotherapy to make room for a person to receive new stem cells; serious side effects can also occur after transplant. Because of these and other considerations, for many years, older adults with blood cancers have not been considered for transplants.

City of Hope has been leading the way to make transplants possible for more older adults with various cancers.

A new study presented at ASH demonstrates transplants are now a possibility and beneficial for patients with myelodysplastic syndromes (MDS). Approximately 13,000 people in the United States each year are diagnosed with MDS, an umbrella term describing several blood disorders that begin in the bone marrow.

Co-led by City of Hopes Ryotaro Nakamura, M.D., director of City of Hopes Center for Stem Cell Transplantation, the study is the largest and first trial to demonstrate the benefits of an allogeneic stem cell transplantation for older adults with MDS as opposed to the standard of care currently provided to these patients. The multicenter trial for patients aged 50 to 75 with serious MDS compared how long transplant patients survived with those who didnt receive a transplant, as well as disease progression and quality of life. The transplant therapy used reduced-intensity conditioning, which delivers less chemotherapy and radiation before transplant and relies more on the anti-tumor effects of the therapy.

Between 2014 and 2018, the study enrolled 384 participants at 34 cancer centers nationwide. It included 260 patients who were able to find a donor for a transplant, as well as 124 patients who did not find a donor for a transplant.

After three years, nearly 48% of MDS patients who found a donor for transplant had survived compared with about 27% of those patients who didnt have a donor for transplant and received current hypomethylating therapy, a type of chemotherapy that is current standard of care for MDS. Leukemia-free survival which is relevant because myelodysplastic syndrome can develop into leukemia was also greater in transplant recipients after three years nearly 36% compared with about 21% for those who did not have a transplant.

There was a large and significant improvement in survival for patients who had a transplant, Nakamura said. The benefit margin in overall survival was over 20% (21.3%) for patients who had a transplant.

In addition, quality of life was the same for both transplant and nontransplant patients. There were no clinically significant differences when taking such measurements as physical and mental competency scores.

This is an extremely exciting study because it provides evidence that stem cell transplant is highly beneficial for older patients with serious MDS and will likely be practice-changing for this group, Nakamura said. Before, many doctors wouldnt even consider a transplant for this group of patients, but our study demonstrates that these patients should be evaluated for a transplant, which could potentially provide a cure for their disease.

The trial is part of Blood and Marrow Transplant Clinical Trials Network, which was established with support from the National Heart, Lung, and Blood Institute and National Cancer Institute, because of a critical need for multi-institutional clinical trials focused directly on improving survival for patients undergoing hematopoietic cell transplantation.

Updated results from a study of a potential new CAR T cell therapy, liso-cel, for relapsed/refractory chronic lymphocytic leukemia

Patients with relapsed or difficult-to-treat chronic lymphocytic leukemia/small lymphocytic leukemia continue to do well 24 months after receiving lisocabtagene maraleucel (liso-cel) chimeric antigen receptor (CAR) T cells, according to Tanya Siddiqi, M.D., director of City of Hopes Chronic Lymphocytic Leukemia (CLL) Program, which is part of the Toni Stephenson Lymphoma Center. She presented these findings during the 2020 ASH annual meeting virtual conference.

Overall, 23 and 22 patients were evaluated for safety and efficacy in this phase 1 trial, respectively. Their median age was 66 and they had received a median of four prior therapies; all patients had received prior ibrutinib, which is one of the standard of care drugs for CLL.

The overall response rate, or patients whose CLL diminished after liso-cel CAR T cell therapy, was 82%, and 45% of patients also had complete responses, or remissions.

After 15 months of treatment, 53% of patients maintained their responses to the therapy, and six patients continued to be in remission. After 18 months, 50% of patients maintained their response, and there were five remissions. All seven patients who completed the 24-month study maintained their response. Median progression-free survival, or the amount of time the cancer did not worsen during and after treatment, was 18 months.

As early as 30 days after receiving liso-cel, about 75% of 20 patients evaluated for the therapys efficacy had undetectable minimal residual disease (MRD, or no detectable traces of cancer) in the blood and 65% had undetectable MRD in the marrow.

These are remarkable results for a group of patients that prior to this CAR T treatment had no good treatment options if they had already progressed on novel targeted therapies like ibrutinib and venetoclax, Siddiqi said. Liso-cel is providing new hope for CLL patients, and the remissions are also long lasting with few serious side effects.

Because of its safety and effectiveness in clinical trials, liso-cel, which targets the CD19 protein on cancer cells, may soon receive approval from the Food and Drug Administration as a commercial therapy for relapsed or refractory B cell lymphoma. City of Hope is also taking part in the phase 2 trial of liso-cel in CLL patients.

Consolidation treatment with brentuximab vedotin/nivolumab after auto stem cell transplant for relapsed/refractory Hodgkin lymphoma patients leads to 18-month progression free-survival

Patients who have Hodgkin lymphoma that has not been cured by initial treatment will usually receive more chemotherapy and an autologous hematopoietic cell transplant. But even after a stem cell transplant, recurrence of the lymphoma is possible.

This multicenter phase 2 clinical trial, led by City of Hope, examined whether treating patients with brentuximab vedotin (BV), an antibody-based treatment that targets delivery of chemotherapy only to Hodgkin lymphoma cells, and nivolumab, which works by blocking the PD-1 immune checkpoint pathway that Hodgkin lymphoma hijacks to evade the immune system, was safe and effective as consolidation to prevent disease recurrence after transplant in patients with high-risk Hodgkin lymphoma.

Alex Herrera, M.D., assistant professor in City of Hope's Department of Hematology & Hematopoietic Cell Transplantation, discussed 19-month progression-free survival for trial participants, as well as overall survival, safety and response rates during ASH.

Fifty-nine patients were enrolled in the trial. Patients received the consolidation treatment starting a median of 54 days after transplant, and received a median of eight cycles of the therapy. The 19-month progression-free survival in patients was 92%, and overall survival in patients was 98%. Only three patients relapsed after receiving BV and nivolumab consolidation after transplant, and one patient passed away due to PCP pneumonia unrelated to the study treatment.

The most common sides effects related to the treatment were peripheral neuropathy (51%), neutropenia (42%), fatigue (37%) and diarrhea (29%).

Using brentuximab vedotin and nivolumab after transplant is a promising approach for preventing relapse of Hodgkin lymphoma after transplant that merits further study, Herrera said.

City of Hope doctors published research on innovative approaches against graft-versus-host-disease

Historically, a bone marrow/stem cell transplant is more likely to be effective if patients have a donor who is a 100% match, or as close to that as possible. Finding that perfect match is more difficult for African Americans, Latinos, Asian Americans and other ethnic groups as bone marrow donor registries are still trying to increase the number of non-white donors.

Transplant doctors are also looking for ways to make the transplant more effective if a perfect match cant be found; donors who are not a 100% or close match are referred to as mismatched unrelated. One major barrier to these transplants being effective is a condition known as graft-versus-host-disease (GVHD). The condition, which is more common in transplants involving mismatched donors, is caused by donated cells that recognize the recipient's cells as foreign and attack them, damaging the skin, eyes, lungs, liver and digestive tract.

In order to help prevent GVHD, therapies can be given to patients after transplant. A prospective clinical trial at City of Hope examined whether using cyclophosphamide after an infusion of stem cells could prevent GVHD.

Thirty-eight patients were enrolled in the trial, which is the first to examine the use of cyclophosphamide in transplants with a mismatched unrelated donor.

With a median follow-up period of 18 months, 87% of patients had survived, and the majority did not relapse or develop severe GVHD.

During the first 100 days post-transplant, acute GVHD incidence was around 50%; most cases were mild to moderate while severe GVHD was only 15%. A year after transplant, 52% of patients had some form of chronic GVHD, but only 3% had moderate or severe chronic GVHD.

The trial also examined toxicities, infections and immune system recovery after the transplant.

Our study showed that patients who received a transplant from a mismatched unrelated donor using post-transplant cyclophosphamide had a comparable outcome to what we see in matched donor transplants with few cases of serious GVHD cases, said Monzr Al Malki, M.D., associate clinical professor of City of Hopes Department of Hematology & Hematopoietic Cell Transplantation and director of unrelated donor BMT and haploidentical transplant programs. Our data support further development of this therapy in transplant patients who would otherwise have no suitable donors and limited treatment options.

City of Hopes Anthony Stein, M.D., also led a pilot trial that examined whether a new treatment approach may reduce the rate of GVHD in patients with acute myelogenous leukemia (AML) who have received an allogeneic hematopoietic cell transplant. Although a transplant can put AML into remission, GVHD remains the main serious complication after transplant, impacting a patients quality of life and increasing health care costs.

Eighteen patients between the ages of 18 and 60 enrolled in the trial. Each patient received a novel conditioning regimen of total marrow and lymphoid irradiation, which targets a patients marrow and lymph nodes while reducing radiation to other parts of the body, and cyclophosphamide, a therapy that suppresses the immune system. Tacrolimus was also provided to patients.

Radiation was delivered twice daily on the fourth day before transplant and on the day of transplant without chemotherapy. Cyclophosphamide was given to patients on the third and fourth day after transplant.

There were mild to moderate toxicities. Acute GVHD developed in two patients and only one patient developed the most serious GVHD. Five patients developed mild chronic GVHD. Nearly 60% of patients had not developed GVHD or the condition had not worsened after a year.

After a year, all patients had survived, and 83% had not relapsed. After two years, nearly 86% of patients had survived, and the relapse number remained the same.

The therapeutic approach did not interfere with the transplant process as all patients engrafted, or the donors cells started to produce bone marrow and immune cells.

This is welcome news for AML patients who receive an allogeneic transplant and are concerned about developing GVHD, said Stein, associate director of City of Hope's Gehr Family Center for Leukemia Research. Our study demonstrated that using this new combination of therapies is safe and feasible and does not interfere with the engraftment process.

In addition, after a year, patients in this trial were no longer taking immunosuppressive therapy and had an improved quality of life, Stein said. He added that because many of the patients didnt have GVHD, health care costs after a year were also lower than if patients required treatment for the condition.

City of Hope now plans to start a larger phase 2 trial using this treatment approach.

Bispecific antibodies continue to show promise against blood cancers

Mosunetuzumab is a promising new immunotherapy for the treatment of relapsed/refractory non-Hodgkin lymphoma (NHL) that recently received breakthrough therapy designation from the Food and Drug Administration. The designation is intended to expedite the development and review of drugs for serious or life-threatening diseases.

Elizabeth Budde, M.D., Ph.D., assistant professor in City of Hope's Department of Hematology & Hematopoietic Cell Transplantation, is leading clinical trials that are showing how well mosunetuzumab works against NHL. At this years ASH, one trial discussed is how the therapy is working for patients with follicular lymphoma.

Mosunetuzumab is a bispecific antibody targeting both CD3 (a protein found on the surface on T cells) and CD20 on the surface of B cells. The therapy redirects T cells to engage and eliminate malignant B cells.

Sixty-two patients, ranging in age from 27 to 85 years old, were enrolled in the trial for follicular lymphoma. They received intravenous doses of mosunetuzumab.

Sixty-eight percent of the patients responded to the therapy, and 50% had a complete response, or went into remission. Consistent complete response rates occurred even in patients with double refractory disease and patients who received prior CAR T cell therapy. Median duration of response was approximately 20 months, and media progression free survival was nearly one year.

Side effects were reported in 60 patients with serious adverse effects in 22 patients. The most frequently reported serious side effects were hypophosphatemia, an electrolyte disorder, and neutropenia, a condition caused by low numbers of white blood cells. Fourteen patients experienced cytokine release syndrome, but none required extensive treatment for it.

Neurological side effects included headache, insomnia and dizziness.

Patients in this trial had high response rates and their disease remained in control for a year, Budde said. This is remarkable because many patients were no longer responding to other therapies.

About City of Hope

City of Hope is an independent biomedical research and treatment center for cancer, diabetes and other life-threatening diseases. Founded in 1913, City of Hope is a leader in bone marrow transplantation and immunotherapy such as CAR T cell therapy. City of Hopes translational research and personalized treatment protocols advance care throughout the world. Human synthetic insulin and numerous breakthrough cancer drugs are based on technology developed at the institution. A National Cancer Institute-designated comprehensive cancer center and a founding member of the National Comprehensive Cancer Network, City of Hope has been ranked among the nations Best Hospitals in cancer by U.S. News & World Report for 14 consecutive years. Its main campus is located near Los Angeles, with additional locations throughout Southern California. For more information about City of Hope, follow us on Facebook, Twitter, YouTube or Instagram.

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City of Hope Doctors Present Innovative Therapies to Better Treat Blood Cancers at American Society of Hematology Virtual Conference - BioSpace

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Skincare tips: Quit smoking as it can lead to premature ageing of skin

Rough-textured appearance, wrinkling and loss of elasticity are signs of ageing of skin. However, age and skin-ageing processes have been considered complex even with different factors. The conventional ageing mostly depends upon the individual genes, proteins, and other intrinsic in isolation. But, the processes of ageing involves interaction of physical, biological, psychological, social and cultural aspects as well. Ageing is alsoaffected by personal habits, diet and living environments beside medical issues. The effects of physical exercise, drugs, vitamins, hormones and antioxidants may have an impact on longevity. Skin is the hurdle that sets apart the body from the outer environment. Besides protecting the body from water loss and infections, it has an important cosmetic role.

Exposure to sunlight is the one of the biggest culprit in ageing skin. Over time, the sun's (UV) ultraviolet light damages certain fibers produced in the skin called elastin. The breakdown of elastin fibers causes the sking to stretch, sag, and lose its ability to restore back after stretching.

There are few ways which can help you slowdown ageing of skin. Here are a few of them:

1. Try drinking 2-3 liters of water per day. Hydrating keeps one's skin looking young, bright and glowing.

2. Exercising regularly decreases the chance for persistent disease, depression and cognitive decline, and can keep your skin looking younger.

3. Use fish oils. These supplements are rich in the essential omega-3 fatty acids EPA and DHA and enhance cardiovascular, vision health; strengthen skin, hair, and nails, and memory skills.

4. Glutathione is the master antioxidant in the body and also known for one of the most powerful supplements for slowing down the ageing process.

5. Alpha Lipoic Acid (ALA) is a potent, versatile antioxidant that helps to fend off inflammation, balances blood sugar and protect skin collagen of one's skin.

6. Stop smoking, it greatly speeds up your skin ages. It causes wrinkles and a dull, sallow complexion.

7. Avoid using alcohol. It is bad for the skin. It dehydrates the skin and with time, damages the skin.

8. Regular exercise can improve circulation and boost the immune system. This may give the skin a more-youthful appearance.

9. Apply a facial moisturiser on a daily basis. Moisturiser keeps water in our skin, giving it a more youthful appearance.

10. SC (Stem cell) transplantation is a promising therapy for the treatment of skin aging. Adipose tissue transplantation could improve skin quality and increase skin volume that adipose-derived stem cells (ADSCs) contribute to the regeneration of skin during ageing.

Promoted

(Dr. Ajay Rana is Dermatologist and Aesthetic Physician, Founder and Director of ILAMED)

Disclaimer: The opinions expressed within this article are the personal opinions of the author. NDTV is not responsible for the accuracy, completeness, suitability, or validity of any information on this article. All information is provided on an as-is basis. The information, facts or opinions appearing in the article do not reflect the views of NDTV and NDTV does not assume any responsibility or liability for the same.

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Aging has implications for a wide range of diseases. Researchers have been looking for ways to halt the aging process for millennia, but such methods remain elusive. Scientists at Harvard Medical School have now offered a glimmer of hope that the aging clock in the eye could be reversedat least in animals.

By reprogramming the expression of three genes, the Harvard team successfully triggered mature nerve cells in mice eyes to adopt a youthful state. The method reversed glaucoma in the mice and reversed age-related vision loss in elderly mice, according to results published in Nature.

If further studies prove out the concept, they could pave the way for therapies that employ the same approach to repair damagein other organs and possibly treat age-related diseases in humans, the team said.

The researchers focused on the Yamanaka factors, which are four transcription factorsOct4, Sox2, Klf4 and c-Myc. In a Nobel Prize-winning discovery, Shinya Yamanaka found that the factors can change the epigenomehow genes are turned on or offand can thereby transform mature cellsback to a stem cell-like state. It has been hypothesized that changes to the epigenome drive cell aging, especially a process called DNA methylation, by which methyl groups are tagged onto DNA.

Past researches have tried to use the four Yamanaka factorsto turn back the age clock in living animals, but doing so caused cells to adopt unwanted new identities and induced tumor growth.

RELATED:Restoring eyesight with genetically engineered stem cells

To test whether the approach works in living animals, the scientists used adeno-associated virus to deliver the three genes into the retina of mice with optic nerve injuries. The treatment led to a two-fold increase in the number of retinal ganglion cells, which are neurons responsible for receiving and transmitting visual information. Further analysis showed that the injury accelerated DNA methylation age, while the gene cocktail counteracted that effect.

Next the scientists tested whether the gene therapy could also work in disease settings. In a mouse model of induced glaucomawhich is a leading cause of age-related blindness in peoplethe treatment increased nerve cell electrical activity and the animals visual acuity.

But can the therapy also restore vision loss caused by natural aging? In elderly, 12-month-old mice, the gene therapy also restored ganglion cells electrical activity as well as visual acuity, the team reported.

By comparing cells from the treated micewith retinal ganglion cells from young, 5-month-old mice, the researchers found that mRNA levels of 464 genes were altered during aging, and the gene therapy reversed 90% of those changes. The scientists also noticed reversed patterns of DNA methylation, which suggests that DNA methylation is not just the marker but rather the driver behind aging.

What this tells us is the clock doesn't just represent timeit is time. If you wind the hands of the clock back, time also goes backward, the studys senior author, David Sinclair, explained in a statement.

The study marks the first time that glaucoma-induced vision loss was reversednot just slowedin living animals, according to the team.

RELATED:Reprogrammed skin cells restore sight in mouse models of retinal disease

Other researchers are also studying regenerative approaches to treating eye diseases. A research group at the Centre for Genomic Regulation in Barcelona just showed that by modifying mesenchymal stem cells to express chemokine receptors Ccr5 and Cxcr6, retinal tissue could be saved from degeneration.

The idea of reversing age-related decline in humans by epigenetic reprogramming with a gene therapy is exciting, Sinclair said. The Harvard researchers intend to do more animal work that could allow them to start clinical trials in people with glaucoma in about two years.

Our study demonstrates that it's possible to safely reverse the age of complex tissues such as the retina and restore its youthful biological function, Sinclair said. If affirmed through further studies, these findings could be transformative for the care of age-related vision diseases like glaucoma and to the fields of biology and medical therapeutics for disease at large.

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Reversing vision loss by turning back the aging clock - FierceBiotech

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ALBANY, N.Y, Dec. 8, 2020 /PRNewswire/ -- Transparency Market Research has published a new research report that provides detailed information about the global amniotic membrane market. The research report tried to shed light on different growth factors, prominent growth challenges, key segments, geographical outlook, and vendor landscape of the global amniotic membrane market. According to the research report, the amniotic membrane market is projected to reach a valuation worth US$2.4 Bn by the end of 2027. Initially, the valuation of the global market was around US$980 Mn, in 2018. In order to achieve such huge surge in terms of revenue, the market is projected to showcase a massive CAGR of ~10% over the course of the given period of assessment ranging from 2019 to 2027.

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Explore a report with detailed research, incisive insights, and in-depth country levels estimations. Gain business intelligence on global Amniotic Membrane Market by Product: Cryopreserved Amniotic Membrane, Lyophilization Amniotic Membrane; Application: Surgical Wounds, Ophthalmology, Others; End User: Hospitals, Ambulatory Surgical Centers, Specialized Clinics, and Research Centers & Laboratories at https://www.transparencymarketresearch.com/report-toc/42059

Global Amniotic Membrane Market Prominent Growth Drivers

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Global Amniotic Membrane Market Notable Players

Some of the notable names operating in the global amniotic membrane market are Amnio Technology, LLC, Katena Products, Inc., MiMedx, Skye Biologics, Inc., Integra LifeSciences, Applied Biologics, Human Regenerative Technologies, LLC, Tissue Tech, Osiris Therapeutics, Inc., and Stryker.

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Global Amniotic Membrane Market: Segmentation

Amniotic Membrane Market by Product

Amniotic Membrane Market by Application

Amniotic Membrane Market by End User

Amniotic Membrane Market by Region

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Genetic Testing Services Market: According to the report, the global genetic testing services market was valued at US$ 41.2 Bn in 2018 and is anticipated to expand at a CAGR of 7.3% from 2019 to 2027, high incidence & prevalence of chronic diseases such as autoimmune, oncology, infectious and others are propelling the growth of global market

Bioprocess Technology Market: According to the report, the global bioprocess technology market was valued at US$ 21.9 Bn in 2018 and is anticipated to expand at a CAGR of 7.9% from 2019 to 2027, The global bioprocess technology market is driven by increase in prevalence of chronic pain, and rise in demand for home monitoring.

Oligonucleotide Synthesis Market: According to the report, the global oligonucleotide synthesis market was valued at US$ 1,966.2 Mn in 2018 and is anticipated to expand at a CAGR of 9.5% from 2019 to 2027, increasing use of synthesized oligonucleotides in diagnostics and research applications, and Technological advancements in synthetic chemistry are projected to drive the global market

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Advanced Therapy Medicinal Products (ATMPs) contain cell therapy, gene therapy, and tissue engineered products. Cell therapy products include cellular immunotherapies and autologous and allogeneic cells for certain therapeutic indications such as adult and embryonic stem cells. Human gene therapy includes products that induce genetic material into individuals DNA in order to treat a disease or abnormal medical condition by replacing faulty or missing genetic material. ATMPs can be a boon for the treatment of diseases that have currently limited or no therapeutic options such as hemophilia, cystic fibrosis, metabolic disorders, muscular dystrophies, skin burns, Alzheimers disease, and cancer. ATMPs are an emerging technology and are in an early stage of development. The approach has potential to cure chronic conditions than standard treatments, which is expected to increase adoption of ATMPs in the near future. The Food and Drug Administration (FDA) and the European Medicines Agency (EMA) regulate and authorize marketing of ATMPs in the U.S. and Europe, respectively.

Increasing prevalence of Alzheimers disease is expected to boost growth of the advanced therapy medicinal products market

Increasing prevalence of Alzheimers disease is expected to drive growth of the advanced therapy medicinal products market. For instance, according to Alzheimers Disease International, in 2017, around 50 million people were estimated to suffer from Alzheimers disease across the globe. Moreover, increasing demand for gene therapies used in the treatment of ocular, neurodegenerative diseases, and several cancers and technological advancements in genetic engineering tools such as RNAi is also expected to propel growth of the advanced therapy medicinal products market.

However, inadequate transparency and lack of investments and regulatory guidance for biopharmaceutical companies to manufacture these therapies and products is expected to hamper growth of the advanced medicinal therapy products market.

Advanced Therapy Medicinal Products Market Taxonomy:

Advanced therapy medicinal products are segmented on the basis of therapy, diseases, and geography

On the basis of products, the global advanced therapy medicinal products market are segmented into:

On the basis of diseases, the global advanced therapy medicinal products market are segmented into:

On the basis of region, the global advanced medicinal therapy products market is segmented into North America, Latin America, Europe, Asia Pacific, Middle East, and Africa. North America is expected to hold a dominant position in the global advanced medicinal therapy products market. This is attributed to significant advancements in the field of cell and gene therapy. For instance, the innovative gene therapy known as CAR-T or chimeric antigen receptor T-cell therapy harnesses the bodys own immune cells to recognize and attack malignant cells. The T-cells are harvested and modified with a new gene. The new gene contains a protein that directs the T-cells to target and kill leukemia cells that have a specific antigen on the surface.

Moreover, increasing approval of new therapies is also expected to boost the market growth. For instance, in 2017, the U.S. Food and Drug Administration (FDA) approved first gene therapy in the U.S. for the treatment of cancer and other serious and life-threatening diseases. Moreover, in 2017, the U.S. FDA approved Kymriah, a cell based gene therapy in the U.S. for the treatment of patients with a form of acute lymphoblastic leukemia. Such developments are expected to boost growth of the market in North America. The market in Asia Pacific is expected to witness the fastest growth, owing to increasing cases of skin burns and cancer.

Major players in the market are focused on adopting merger and acquisition strategies to expand their product portfolio. For instance, Pfizer acquired Bamboo Therapeutics, a biotechnology company focused on developing gene therapies for the treatment of patients with diseases related to neuromuscular conditions and the diseases affecting central nervous system. The acquisition is expected to significantly expand Pfizers expertise in gene therapy by providing clinical and pre-clinical assets to balance the rare disease portfolio of company with advanced recombinant Adeno Associated Virus vector design and production technology, which is fully functional phase I/II gene therapy with manufacturing facilities.

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Key players operating the advanced therapy medicinal products market include, Uniqure, Pfizer, Bluebird Bio Inc., BioMarin Pharmaceutical, Novartis AG, GE Healthcare, Shire Biotechnology, and Kite Pharma.

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Advanced Therapy Medicinal Products Market 2019 Global Industry Analysis By Size, Share, Trends and - PharmiWeb.com

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DUBLIN--(BUSINESS WIRE)--The "Europe Tissue Engineering Market Forecast to 2027 - COVID-19 Impact and Regional Analysis by Material Type, Applications, and Country" report has been added to ResearchAndMarkets.com's offering.

The Europe tissue engineering market is expected to reach US$ 7,368.93 million by 2027 from US$ 2,798.86 million in 2019; it is estimated to grow at a CAGR of 13.2% during 2020-2027.

The market growth is primarily attributed to the increasing incidences of chronic diseases, road accidents, and trauma injuries, and technological advancements in 3D tissue engineering techniques. High cost associated to the tissue engineering process is one of the major factors restraining the growth of the market. Additionally, increasing financial contributions by government and private sector are likely to fuel the growth of the Europe tissue engineering market during the forecast period.

Tissue engineering is a blend of material methods and cellular activities. This approach involves the use of physicochemical and biochemical attributes of humans to replace the biological tissues and strengthen them. It is an innovative technology that works either separately or in conjunction with scaffolds, stem cells, regenerative medicine, and growth factors or negotiators. The process utilizes molecular and cellular processes in combination with the principles of material engineering to surgically repair and restore tissue.

The tissue engineering market in Europe is estimated to grow at a significant CAGR during the forecast period, and the growth is driven by the increase in research activities, growing demand for organ transplants, escalating number of initiatives by market players for expanding their presence in the region, and higher adoption of stem cell research in several European countries.

In the Europe, due to an increasing number of COVID-19 patients, healthcare professionals and leading organizations are rechanneling the flow of healthcare resources from R&D to primary care, which is slowing down the process of innovation. Further, the pandemic is also hindering the conduct of clinical trials and drug development, and the operations of diagnostic industry in Europe.

For instance, Stryker Corporation, a well-known player in the tissue engineering industry, has diverted operations to manufacture COVID-19 diagnostics and PPE kits. Moreover, according to a recent survey published by Medscape in July 2020, substantial disruption has been witnessed in routine research activities that include tissue engineering and regenerative medicines as a result of the COVID-19 pandemic. The rapid increase in the number of the infected patients in the Italy and Spain is likely to result in the slowdown of the market growth in the near future.

In 2019, the biologically derived material segment accounted for the largest share of the Europe tissue engineering market. The growth of the market for this segment is attributed to the rising adoption of biomaterials due to their natural regenerative potential to restore tissue functioning and ability to facilitate the on demand release of chemokines with the procedure. Further, the synthetic material segment is likely to register the highest CAGR in the market during the forecast period.

Key Topics Covered:

1. Introduction

1.1 Scope of the Study

1.2 Report Guidance

1.3 Market Segmentation

2. Europe Tissue engineering Market - Key Takeaways

3. Research Methodology

4. Europe Tissue engineering Market - Market Landscape

4.1 Overview

4.2 PEST Analysis

4.3 Expert Opinion

5. Europe Tissue engineering Market - Key Market Dynamics

5.1 Key Market Drivers

5.1.1 Increasing Number of Road Accidents and Trauma Injuries, and Elevating Incidence of Chronic Diseases

5.1.2 Technological Advancements in the Field of 3D Tissue engineering

5.1.3 Government and Private sector funding

5.2 Key Market Restraints

5.2.1 High Cost associated with tissue engineering

5.3 Impact Analysis

6. Tissue engineering Market - Europe Analysis

6.1 Europe Tissue engineering Market Revenue Forecasts and Analysis

7. Europe Tissue engineering Market Analysis - By Material Type

7.1 Overview

7.2 Europe Tissue engineering Market, By Material Type 2019-2027 (%)

7.2.1 Europe Tissue engineering Market Material Type Segment Revenue and Forecasts to 2027, By Material Type (US$ Mn)

7.3 Biologically Derived Material

7.4 Synthetic Material

7.5 Other

8. Europe Tissue engineering Market Analysis - By Application

8.1 Overview

8.2 Europe Tissue engineering Market, By Application 2019-2027 (%)

8.2.1 Europe Tissue engineering Market Revenue and Forecasts to 2027, By Application (US$ Mn)

8.3 Orthopedic, Musculoskeletal and Spine

8.3.1 Overview

8.3.2 Europe Orthopedic, Musculoskeletal and Spine Market Revenue and Forecasts to 2027 (US$ Mn)

8.4 Skin

8.5 Cardiology and Vascular

8.6 Neurology

8.7 Others

9. Europe Tissue engineering Market Revenue and Forecasts To 2027 - Regional Analysis

10. Impact of COVID-19 Pandemic on Europe Tissue Engineering Market

10.1 Europe: Impact Assessment of COVID-19 Pandemic

11. Company Profiles

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Europe Tissue Engineering Market Forecast to 2027 - COVID-19 Impact and Regional Analysis by Material Type, Applications, and Country -...

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NHS England has now ordered a full clinical review of each GIDS patient offered puberty blockers under the age of 16. I was told privately by some the case was hopeless, that the bar had been captured by transgender activists, that institutions had been captured by ideologically driven charities, says Evans. Certain trans groups have really cultivated an atmosphere of fear among children and their families. But Im just very relieved and obviously pleased with the ruling.

Evans has worked for the NHS her entire life, and met her husband, Marcus, who was also in the field of psychoanalytic practice, when training in Springfield Hospital in Tooting Bec, south-west London. What drew me to therapeutic practice was trying to understand the internal emotional worlds of other people, she says, because with understanding comes an improved experience of life. I had an instinct that drugs and physical treatments were never going to provide an answer for people in emotional distress.

When Evans started at the Tavistock in 2003, she was proud to be working in a tiny team at a pioneering organisation. But on hearing a colleague describe how, after only a few assessments, they had referred a distressed 16-year-old boy who thought of himself as female for hormone treatment, her jaw dropped. She recalls feeling something was very, very wrong with the GIDS approach.

In her early years as a psychiatric nurse, she had witnessed treatments, such as electroconvulsive therapy, that are now widely condemned: I know enough of the history of psychiatry to always be cautious about intervention.

Evans had assumed she would be able to use her psychotherapeutic skills to support the scores of children referred each year. When she raised the possibility of alternatives to medication, Evans was advised the service would not have any patients without the offer of puberty blockers. Last year, GIDS had 2,590 children referred for them, compared with 77 patients a decade ago.

Evans began to become concerned by the influence of transgender organisations on clinical practice at the Tavistock. It was becoming increasingly difficult to discuss the needs of the patients who displayed clinical curiosity. The beginnings of the more affirmative model of care [whereby the cross-sex identity of a child with gender dysphoria is affirmed by referring to the child as if it were the opposite sex]were taking root.

To this day, Evans believes this practice has not been proven to alleviate mental distress, and that its use within the GIDS is based on political pressures and fears of litigation, rather than what would be clinically, professionally appropriate.

Back in January, Evans launched a crowdfunding campaign with Mrs A to cover legal costs for the judicial review. Immediately, she received letters from distressed parents who had been told that they were at fault when their children had harmed themselves.

Due to personal circumstance, Evans withdrew, passing on her role as claimant to Keira Bell, who was prescribed puberty blockers by GIDS when she was 16. She had a double mastectomy aged 20, and now regrets transitioning, which has left her with no breasts, a deep voice, body hair, a beard, affected sexual function and who knows what else that has not been discovered. She may well be infertile as a side effect of the drugs.

More than a decade after she had walked out of the Tavistock, Evanss husband convinced her to push for a judicial review about some of the practices both had witnessed there.

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As the latest wave of coronavirus disease 2019 (COVID-19) rises, the first day of the San Antonio Breast Cancer Symposium 2020 opened up with a session that examined how the pandemic is disproportionately affecting care for minority patients.

Deborah Doroshow, MD, PhD, assistant professor of Medicine, Hematology, and Medical Oncology at the Tisch Cancer Institute, opened the session with an anecdote from April when she was doing rounds at the institute and met a Black woman in her 60s who was hospitalized for COVID-19. Three years prior, the woman had undergone a lumpectomy and radiation for hormone-positive breast cancer; she was currently on hormonal therapy with an aromatase inhibitor.

While in the hospital, the patient was growing short of breath and showing signs of being tachypneic and hypoxic; this led Doroshow to ask a rapid response team for high-flow nasal cannula. However, Doroshow was met with a response of, She was a cancer patientwhy be so aggressive?

The response, said Doroshow, rasied a larger question: What role might gender and race also be playing here?

Its well documented that race and ethnicity carries weight when it comes to outcomes across a myriad of conditions, and COVID-19 is no exception. Doroshow gave the example of a 3600-patient cohort from Louisiana, of which Blacks accounted for 70.4% of the COVID-19 infections despite representing less than one-third of the population.1 Similarly, among 28,000 tested patients in New York, 6000 tested positive for COVID-19, with Blacks accounting for nearly 1 in 4 infections and Hispanics accounting for 29% of infections while representing 19.2% and 12.8% of the population, respectively.2

Data from the CDC show that American Indians/Alaskan natives, Blacks, and Hispanic/Latinos are at higher risk of developing COVID-19, being hospitalized for the virus, and dying from COVID-19 infection.3 However, the agency does note that race/ethnicity are risk markers for other underlying conditions that impact health, such as socioeconomic status and access to healthcare.

Now, enter cancer. Having cancer or a history of cancer alone leaves a patient is at significantly higher risk of dying if they are infected with the virus. Data from nearly 4000 patients included in the COVID-19 and Cancer Consortium showed that 30-day all-cause mortality hit 14% overall and 23% among those hospitalized with the virus.4

So, both race/ethnicity and cancer on their own are associated with poorer COVID-19 outcomes, but what happens when you combine the 2?

Doroshow is an investigator in the COVID-19 and Cancer Outcomes Study, a multicenter, prospective study looking at the impact of the pandemic on cancer care delivery and outcomes among patients with active cancer or a history of cancer. The study includes 2300 patients who visited Mount Sinai Hospital or Dana-Farber Cancer Institute between March 2 and March 6, 2020. The team of researchers performed a 3-month retrospective analysis going back to December 2019 (baseline period), as well as a 3-month prospective analysis going through early June (pandemic period).

What they found was Black and Hispanic patients were less likely to have telehealth visits and were far more likely to be diagnosed with COVID-19, with an odds ratio of 1.86 and 3.19, respectively. When looking at pandemic-related delays in cancer care, Hispanic patients were far more likely to delay care, while Black patients had a trend toward this.

Why these disparities? questioned Doroshow. One can certainly point to a variety of factors. One might say that increased vulnerability to COVID could be related to the fact that minority patients are more likely to be frontline workers or perhaps to live in multigenerational homes. Could the possibility of poorer outcomes be related to poorer baseline health or disparities in health literacy or insurance, leading patients to seek care later on?

With a focus on the continuity of care, Doroshow outlined several focus points for closing these disparities. She argues providers should not assume all patients:

We must be persistent in not losing out most vulnerable patients to follow up, urged Doroshow. Ask about living and social situations; educate and support safe public health practices to the extent they are possible; provide nonjudgmental, supportive education; help our patients get to the clinic and stress the importance of not delaying urgent care; ensure telehealth is provided to patients who are able to participate fully and who are open to this mode of care; and ask of patients what they need from us.

References

1. Price-Haywood E, Burton J, Fort D, Seoane L. Hospitalization and mortality among Black patients and White patients with COVID-19. New Engl J Med. 2020; 382:2534-2543.

2. Wang Z, Zheutlin A, Kao Y, et al. Hospitalised COVID-19 patients of the Mount Sinai Health System: a retrospective observational study using the electronic medical records. BMJ Open. 2020;10(10):e040441.

3. COVID-19 Hospitalization and Death by Race/Ethnicity. Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/covid-data/investigations-discovery/hospitalization-death-by-race-ethnicity.html. Updated November 30, 2020. Accessed December 8, 2020.

4. Assessment of clinical and laboratory prognostic factors in patients with cancer and SARS-CoV-2 infection: The COVID-19 and Cancer Consortium (CCC19). Presented at: ESMO 2020; September 19-21, 2020. Abstract LBA72. doi: 10.1016/annonc/annonc325

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The Role of Race, Ethnicity, and Cancer in the Time of COVID-19 - AJMC.com Managed Markets Network

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By Rich Larson, News Director

The Northfield Public School District has announced that they have terminated an employee of the Early Venture Childcare Center for administering melatonin to at least one infant without consent of that childs family.

Northfield Public Schools Superintendent, Dr. Matt Hillmann said that, once alerted, the district moved swiftly to investigate.

We know that she placed at least one tablet into the bottle of an infant, and possibly others. And so, we consulted with the Northfield Police Department on Wednesday, who suspect that its a child size dose of Melatonin. And of course, we made the appropriate reports to the Minnesota Department of Human Services as well as Northfield Police Department. And [on Wednesday] we did terminate that employee based on the investigation results. We have no evidence that anyone else was involved.

Hillmann also said that the district will offer help and resources to the families of the victim,as well as the other children enrolled with EarlyVentures.

Were going to be providing support for those families. Thats the sense of urgency we have right now, to make sure we are supporting those families in that classroom. Theyre going to have access to parent educators and medical personnel to help provide them with education and support.

We just cant emphasize how angry and appalled we are as a district that an employee would violate the trust that parents put in us every day to care for their children.

According to the Mayo Clinic, Melatonin is a hormone that plays a role in sleep and is commonly used to treat sleep disorders such as insomnia and jet lag.

Dr. Hillmann acknowledged the breach of faith that this incident may have caused and said that the district will work very hard to meet the communitys expectations.

We understand that an incident like this diminishes trust with our families, specifically the families involved. And we will work as hard as we can to rebuild that trust with those families and our community.

Early Ventures is achildcarecenter for infants, toddlers and preschoolers that is licensed by the Minnesota Department of Human Services and operated by the Northfield Public Schools. Dr. Hillmann said Ms. Woodcock had been employed there for four years.

Rice County break up theft ring

Rice County law enforcement has announcedthat they have broken up a theft ring that was involved in more than 20 different burglaries across the state.

Authorities said Troy Thomas Cook and Angela Michele Degrood, both of Faribault have been taken into custody after stolen property was discovered at their home. Both areCHARGEdwith receiving stolen property, additionally, Cook is charged with Ineligible Possession of a Firearm and 5thDegree Possession of a Controlled Substance.

On November 25th, members of theRice County Sheriffs Office, the Faribault Police Department and the Cannon River Drug and Violent Offender Task Force executed search warrants at 1016 Division Street West in Faribault and discovered a stolen residential water heater, a stolen arc welder, and an oxygen and acetylene torch. Further investigation led the authorities to property that they say was involved in more than 20 different burglaries across the state. Rice County Sheriff Troy Dunn said much of the property recovered was high quality equipment.

Everything from hand tools theamountof tools they recovered was unbelievable. There were very expensive tampers that you would use prior to putting down concrete. There were auto levelers, the things that landscapers and construction companies use to make sure that the grade is level, which are GPS equipped.

Dunn also commented on the work done by the detectives, investigators and agents involved in the case, calling them tenacious, and explaining why stopping an operation like this one is so important.

Some calls come into my office sometimes, say Sheriff I need to report a theft or a burglary. And we talk to these people. Our investigators share this with [thieves and burglars] when theyre arrested: youre not only stealing peoples items,youretaking away their feeling of security. Kids cant sleep. They run into theirparents room at night because theyre afraid somebodys going to break into their house and steal something. When you think of it that way, youre doing more than just stealing someone elses property. You are taking away someones sense of security and affectingthirquality of life.

If found guilty, Degrood is facing 5 years in prison and a $10,000 fine.

With the additional charges and his prior history, Cook is facing a fine of as much as $50,000 and 25 years in prison.

Big Woods park closed for special deer hunt

And the Big Woods State Park will be closed this weekend due to a special deer hunt that will take place in the park.

The DNR announced last month the park would close on December 5th& 6thin order to facilitate a special hunt designed to manage the parks deer herd and protect its natural resources.

Too many of one animal or plant species in an area can start to throw off the balance of other species in that area, said Tavis Westbrook, natural resource program coordinator for the Minnesota DNR. When there are too many deer in a park, they feed too much on certain trees and native plants, so occasionally we allow deer hunts as a way to thin the herd.

The hunt is open to firearms, muzzle loaders and archery, however the deadline to apply for a permit for a special hunt like this one has long since passed.

Big Woods State Park will resume regular hours of operation at 8am on Monday.

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Northfield school district employee terminated for unauthorized treatment of infant; Rice County law-enforcement breaks theft ring; Big Woods State...

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PCOS is "a hormonal disorder common among women of reproductive age," the Mayo Clinic notes. "Women with PCOS may have infrequent or prolonged menstrual periods or excess male hormone (androgen) levels. The ovaries may develop numerous small collections of fluid (follicles) and fail to regularly release eggs."

In Keke Palmer's December 2020 Instagram share, in which she revealed she's been suffering from the disorder her "entire life," she also explained how she finally found out what she's been dealing with after numerous acne treatments failed.

" ... It took ME taking a personal look into my family that has a history of diabetes and obesity, to understand what was ACTUALLY happening with me," she divulged, explaining that she "did the research" and took her findings to a doctor, which led to "a proper diagnosis" of PCOS.

"I'm not saying trust web md for everything haha," Palmer joked, "but what I am saying is no one can help us like we can help ourselves." There's nothing like being your own advocate, and in Palmer's case, her deep dive into her medical history led to an important discovery about herself.

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How Keke Palmer found out the truth about her PCOS - Nicki Swift

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This article was originally published here

J Turk Ger Gynecol Assoc. 2020 Dec 4;21(4):272-278. doi: 10.4274/jtgga.galenos.2020.2020.0119.

ABSTRACT

Coronavirus disease-2019 (COVID-19) has reduced the availability of health resources which will affect treatment of gynecological cancers. The present study aimed to provide a treatment protocol for patients with gynecological cancers during the global COVID-19 pandemic. International databases with keywords of COVID-19; Severe Acute Respiratory Syndrome; Middle East Respiratory Syndrome; gynecologic cancer; cervical cancer; and vaginal cancer, vulvar cancer, ovarian cancer, endometrial cancer, tumor, elective surgery, chemotherapy, radiotherapy, cancer, guideline, guidance, women, management, outpatient clinic visits, and triage were comprehensively searched. All the obtained guidelines were studied and the contents were summarized. During the COVID-19 pandemic, early stage endometrial cancer was preferably treated with hormone therapy while radiotherapy was given in preference in later stages. Cervical intraepithelial neoplasia 3 and high-grade squamous intraepithelial lesions should be treated immediately after diagnosis using at least a loop electrosurgical excision procedure while any major surgery should be postponed by 10-12 weeks. In the early stage of cervical cancer, surgery may be delayed by 2-4 weeks, and radiotherapy prescribed for the intervening period. In cases of an ovarian mass with negative tumor markers, no sign of cancer on imaging investigations, no ascites, a low serum CA-125 level, and no papillary projection or vegetation in the base of the cyst, the patient may be given hormone therapy for 2-3 months. In cases of newly diagnosed confirmed ovarian cancers, surgery should be performed as early as possible (maximum: 2-3 weeks). Vulvar and vaginal cancers can be treated within 10-12 weeks of diagnosis, but radiotherapy should be given in preference in this situation. A molar pregnancy is an oncological emergency for which a suction curettage is mandatory; the patient must be monitored for metastases. Information concerning the choice between open or laparoscopic surgery is limited. Given that any patient may be an asymptomatic carrier of the coronavirus, major surgery should be preceded by chest computerized tomography, with and without contrast medium, in order to detect lung lesions. Evidence concerning these recommendations is limited because of the novel and unknown nature of the COVID-19 pandemic. Furthermore, data pertaining to ethical debates about delayed treatment and treatment approaches deviating from current guidelines are also limited.

PMID:33274617 | DOI:10.4274/jtgga.galenos.2020.2020.0119

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Gynecological cancers and the global COVID-19 pandemic - DocWire News

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Being sleep deprived is hard for parents of a new baby, but very young kids typically dont sleep long stretches at night. iStock / Special to On the Minds of Moms

Other than warming our hearts, infants and very young children spend more time sleeping than doing anything else. The American Academy of Sleep Medicine recommends children 4 months to 12 months get between 12 and 16 hours in each 24-hour period more than half the day. Before 4 months, there's a wide range of normal so the general advice is to let them do what it seems like their little bodies want to do, since sleep is integral to all the work of growing their bodies and developing brains.

Very young children aren't supposed to sleep through the night, or even for more than a few hours at a time for the first several months of life. Waking is usually a sign of another biological need, such as food or a diaper change. During the night, the simplest way to get them back to sleep is simply to take care of their needs quickly and quietly without turning on the light if possible and get them back to bed.

Studies show that having a nightly bedtime routine is associated with better sleep in children of all ages. For babies, that routine can be as simple as a few minutes of rocking and sharing a favorite lullaby.

Tots who are learning more about boundaries and control can start taking a more active role in their bedtime routine at this age. iStock / Special to On the Minds of Moms

When your baby gets a little bigger, routines are still very important, but they'll want to have more power over things in their life. At this age they're starting to test boundaries, so giving them control over small choices around sleep like what book to read, which side of the bed to put their head on or which stuffed animal to to snuggle. This helps them feel like they have some authority while avoiding power struggles which we all learn eventually that no one really wins.

At this age, kids should be sleeping between 11 and 14 hours a day, including two naps a day at the start of this period, dropping to one nap a day as they turn 2.

Night terrors start appearing in some children around this age. Kids may wake up screaming, unable to properly communicate. Experts recommend doing your best to quietly soothe your child, keep them in bed and help them get back to sleep. Usually children don't wake up fully during night terrors or remember them in the morning. They can be frightening for parent and child, but are generally normal. If they're frequent or are causing daytime sleepiness, talk to your pediatrician.

Preschoolers tend to stall the bedtime process, but there are ways to make things go smoothly. iStock / Special to On the Minds of Moms

We all know it when we see it tantrums, emotions running high and hyperactivity. Its what a lack of sleep looks like in a preschooler. When they dont get the recommended 10 to 13 hours of sleep in a 24-hour period, thats when these fun times can rear their ugly heads. While we make our best attempts at getting those squirrly littles safe and sound asleep at a decent time, there are often many hurdles to jump through: the bathroom breaks, the unquenchable Im- going-to-die-if-I-dont-get-a-drink thirst, and the just one more thing pleas.

We get it. Were all tired from a full days worth of adulting, but throwing in the towel here may have some drawbacks because its not only about preventing a bad day. A lot of functions important to growth, health, memory and cognitive development happen during sleep. Nerve cells are rewired, muscles are restored and human growth hormone is released.

Basically, kids need their sleep so they can grow and learn at an optimal rate. If your kid is dealing with some serious FOMO during bedtime that keeps them springing out a bed for just one more thing here are a few things to try:

Prep the brain by turning off screens about one hour before bedtime.

Create a calm environment. As bedtime nears, dim the lights and choose relaxing activities, such as reading or talking.

Stick to a consistent sleep schedule throughout the entire week. Yes, even on weekends, as much as possible.

Involve them in planning their bedtime routine. Whatever relaxing activities you choose to make part of their bedtime ritual, be sure to explain the rules, e.g. number of books, time limits, etc.

Kids age 6 to 9 still need a good amount of sleep, which may require some experimentation before you find the right amount for your child. iStock / Special to On the Minds of Moms

These are some big years for big kids. Theyre becoming more immersed in the large world around them, which means theyre also experiencing more learning, social and emotional challenges than ever before. All the more reason getting the American Academy of Sleep Medicines recommended nine to 12 hours of sleep a day is important.

According to AASM when kids are able to regularly get this amount of good quality sleep their attention, behavior, learning and memory operate at optimal levels. And like everyone else, their quality of life as well as overall mental and physical health are enhanced. Good, ample sleep is like setting the stage for their success.

So how do you know when your kids arent hitting their sleep sweet spot? Here are some signs to look out for from the Cleveland Clinic:

You need to awaken your child three to four times before they actually get out of bed.

Your child tells you they're tired during the day.

They need catch-up sleep on weekends.

They fall asleep during the day.

If these sound familiar, work toward getting back on track. Start bedtime earlier by about 15 minutes per day until you hit the right amount of sleep per night for your child. Also, be sure to stick to a similar schedule on the weekends, staying within the same wakeup and bedtime by 30 to 45 minutes. If you havent already, this may be a good time to start using an alarm clock. And finally, consider a relaxing bedtime routine, which can be helpful for anyone at any age really.

It may sound crazy, but tucking in your tweeners is still a great habit to set the stage for quality sleep. iStock / Special to On the Minds of Moms

This can be a busy time for kids this age, as school activities pick up and homework gets to be more of an actual thing. But parents should not let up on insisting on nice, early bedtimes because while they might seem a little bit old to do the traditional tuck-in, their growing bodies and brains still desperately need that good, quality sleep.

According to the sleepfoundation.org, tweeners require 9-11 hours of sleep per night. And while grumpiness and grogginess will certainly follow a night of inadequate sleep, thats the least of the worries. According to experts, children who do not get enough sleep on a regular basis are at a much higher risk of developing anxiety and depression. And what are kids this age often doing later at night anyway when they should be in bed? They might be sitting on their phones, which can not only contribute to depression and anxiety due to excessive social media, but the screens emit a blue light that stimulates the brain, making it even more difficult for children to fall asleep. Having them put the phones up in the kitchen and tucking them in like theyre little can do wonders for kiddos this age.

Inadequate sleep can also hit children physically in terms of weight gain. Studies show that when kids dont get enough sleep, it disrupts their hormone levels, which regulates appetite and food intake. This can lead to overeating and a craving for sugar and bad carbs. Moral of the story? Tuck them in. You read that right.

Its a common stereotype assigned to teenagers in movies and TV shows. They emerge from a messy bedroom, yawning and running fingers through disheveled hair oblivious to whats going on in the world. Hilarity ensues when mom or dad crack wise about the teen sleeping all day.

The truth is teenagers do need more sleep than the average adult. But despite what Hollywood implies, most teenagers are not getting enough of it.

The American Academy of Sleep Medicine has recommended that teenagers aged 13 to 18 years should sleep 8 to 10 hours per 24 hours. However, in a 2015 survey, the Centers for Disease Control found seven out of 10 teenagers were not getting the minimum eight hours of sleep a night.

If the lack of sleep only meant a few extra yawns at the breakfast table, it would be no big deal. However, doctors say teens who dont get enough sleep have a higher risk of obesity, diabetes, injuries, poor mental health, and problems with attention and behavior.

Parents can do their part to help their teen sleep better, including setting up a media curfew. Require your teen to get off SnapChat, TikTok and all social media and electronics no later than 9 p.m. The brain needs time to unwind and settle into a good nights sleep. And while teens are more likely than other age groups to have active social lives outside the family, encourage your teen to get the same amount of sleep every night. While it might feel good to catch up on your sleep on the weekends, in the long run, getting a solid eight to 10 hours a night is better for your teens mental and physical health.

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Here's how much sleep your kids need to stay healthy - INFORUM

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Simply known as birth control pills, these pills are made out of hormones higher than a woman's normal body levels. These pills have to be taken daily to be effective. The constant intake of hormones will prevent ovulation (the release of the ovum) throughout the menstrual cycle and thus prevent pregnancy.

There are two types of pills - the combined (estrogen and progesterone) and the progesterone-only pills.

Both types can be bought over-the-counter from a pharmacist without a prescription. Ideally though, you should seek medical advice on both the hormones before using it as everyone has different contraindications, e.g. people with high blood pressure cannot take pills with estrogen in it.

OCPs are often advised for women who not only need birth control, but also if they have heavy and painful periods because these pills can make periods become more regular, shorter, less heavy, and less painful.

These pills can be used to treat acne too. However, it may also worsen the condition in some people, which is exactly why you should seek medical advice.

Drawbacks: Users have to take the pill at almost the same time every single day. It doesn't protect against STIs. It can cause weight gain and blood clotting issues (venous thromboembolism).

Effectiveness: 91% if used correctly

Cost: RM30 to RM60 for a box for one month

Common brands in Malaysia: Diane, Mirogynon, Regulon, Rigevidon, Yasmin, Yaz

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Here Are The Types Of Birth Control Available In Malaysia And How Much They Cost - SAYS

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Some people are lucky. They binge on pizzas, burgers, ice creams, fries and chocolates, but dont seem to add an inch to their waistlines. And we wonder why they never put on weight. Its genetics, they say. True, their genes gives them high metabolism.

Thats only partly the truth. The other part is perception. We only see them wolf down high-calorie food, but we dont know what they do during the rest of the day. Maybe they have only one or two meals a day so that the calorie intake evens out. They could have an active lifestyle to burn the calories: they may be playing a sport regularly or at least going for long walks.

People with certain health conditions like hyperthyroidism and diabetes dont pile on the pounds. Eating disorders such as bulimia and anorexia too can prevent people from gaining weight. So weight management is more than just genetics and portion control.

Weight gain and weight loss: What science says

Genetics: Does it decide your body weight?

Genetics plays a major role in managing body weight since it influences metabolic rate and hormone sensitivity, allowing some people to burn calories faster than others. It also may make them less sensitive to food cues, making it easy for them to resist cravings. But genetics is not the only reason why some people stay slim no matter what they eat.

There's no evidence that some people are born to burn more calories than others, Dr Ines Barroso, a researcher at the University of Cambridge in England, says, although researchers have identified over 250 different regions of DNA associated with obesity. In a 2019 study published in PLOS Genetics, thin participants were found to have fewer genes associated with obesity. But Barroso, a co-author on the study, says genes alone don't determine your weight. "We didn't find genes that were exclusively either protecting from obesity or predisposing someone to obesity.

Kathleen Melanson, a professor of nutrition and food sciences at the University of Rhode Island, US, concurs. Our tendency to gain weight or maintain our weight isn't pre-determined, but it's also not entirely under our control. There's genetic, nutritional, and even behavioral factors involved," she told Live Science.

Starvation hormone: How does it work?

Leptin is a hormone that helps in regulating appetite. People with higher leptin sensitivity tend to control cravings better. An absence of leptin or leptin resistance [when the body doesnt respond to the brain signals.] can lead to uncontrolled feeding and weight gain. So people with leptin deficiency can be obese.

Known as starvation hormone, leptin is a protein that tells the brain if theres enough energy stored in fat cells to carry out normal metabolic processes required to maintain the body. When leptin levels are above a certain threshold [higher sensitivity], the body burns energy at a normal rate, but when it dips, the body conserves energy and stimulates hunger pangs.

The thinness gene

Researchers at the University of British Columbia have identified a gene called Anaplastic Lymphoma Kinase (ALK) which they say plays a role in resisting weight gain. Dr. Josef Penninger and his team reported the discovery of a mutation in the ALK gene in a thin group of people in a study published in the journal Cell.

The gene is known to mutate frequently in several types of cancer, driving the development of tumours. ALK acts in the brain, where it regulates metabolism by integrating and controlling energy expenditure, says Michael Orthofer, the studys lead author and a post-doctoral fellow at the Institute of Molecular Biology in Vienna.

Digestive enzyme: How it regulates body fat

MGAT2 (monoacylglycerol acyltransferase-2) is a digestive enzyme that regulates fat in the body. So if the enzyme is absent and the body will be unable to use fat, helping them to stay thin. Scientists at the University of California in San Francisco found that mice without the gene for MGAT2 can eat whatever they want without getting fat. The results suggest that the enzyme has a pivotal role in lipid metabolism in the small intestine, and curbing MGAT2 can help in the treatment of obesity-related metabolic disorders, according to a journal published by the US National Institutes of Health's National Library of Medicine.

Basal metabolic rate: How it influences calorie spend

Basal metabolic rate is the minimal rate of energy burned per unit time by the body when its at rest. This energy is spent on normal metabolic processes like breathing, pumping of the heart, and functioning of brain. So people with high basal metabolic rate expend more calories at rest and they dont gain weight easily. The rate decreases as a person grows older and it increases when theres a spike in muscle mass.

Food choices: How it affects body weight

Weight gain is intrinsically linked to the quantity and quality of food consumed. If people eat large quantities of food thats less nutritious and low in calories, they wont gain weight. High sugar and highly processed food will have alarming levels of calories that will increase a persons weight. So the right amount of nutritious food is the key.

Physical activity: Why its important

An active lifestyle makes a huge difference. You dont have to hit the gym regularly, moving around a lot is good enough. Some people are predisposed to moving more and that extra movement can burn a lot of calories even though its not a workout. Even non-conventional exercises results in calorie burn over an extended period.

Non- conventional exercises: What are they?

Non-exercise activity thermogenesis (NEAT) is an efficient way to manage body weight. NEAT constitutes body movements that do not qualify as exercise but can help expend calories. Walking around while talking over the phone, any kind of physical labour like cooking or cleaning, walking a dog, using a standing desk, climbing stairs, and fidgeting are some of them. It's also called non-exercise physical activity (NEPA). NEAT increases the metabolic rate, leading to a substantial energy loss over a long period.

Appetite regulatory system: How food intake is regulated

The nervous system and hormones in the blood interact to signal when a person is hungry or full. This is called the appetite regulatory system. When energy stores in the body are depleted, a stimulus for appetite will trigger the start of feeding, and its counterbalanced by satiety, the opposite stimulus to stop eating.

Sleep: Why its very important

The hormone cortisol plays a vital role in regulating hunger. So sleep deprivation sleep leads to stimulation of cortisol resulting in weight gain.

Skinny fat: The dangers that lie beneath

Skinny fat is medically known as metabolically obese but within a normal weight range for the height. Its a phrase used to describe people who look fit and healthy, but suffer from a range of health problems due to a lack of exercise or poor diet. These people can have the same diagnostic markers of diabetic patients like high blood sugar, low good cholesterol, high triglycerides, inflammation, and high blood pressure. They can also have vitamin deficiencies, resulting in fatigue and poor levels of concentration.

Underweight: Its as dangerous as obesity

If a persons BMI is below 18.5, he or she is said to be underweight. That body mass is not enough to sustain optimal health. According to studies quoted by Healthline, being underweight can raise the risk of early death in men by 140 per cent in men, and by 100 per cent in women. It can also decrease immunity, increase chances of infections, osteoporosis and fractures, besides causing fertility problems.

Eating disorders prevent weight gain and impact health

Eating disorders are medical conditions that adversely impact health. An excessive focus on body weight results in dangerous eating behaviours that deprive body of nutrition. This can affect the heart, digestive system and other organs, and trigger major diseases. The most common eating disorders are anorexia nervosa, bulimia nervosa and binge-eating disorder.

Anorexia nervosa

People suffering from anorexia nervosa have an excessive fear of gaining weight, even if they are severely underweight. So they may restrict their food intake or compensate it through various purging behaviours like forced vomiting or use of laxatives. Some others exercise obsessively to shed weight. Over time, the body may go into starvation and they could slip into depression.

Bulimia nervosa

This binge-eating disorder can go unnoticed as the patients may not be thin. These people eat frequently, gorging a huge amount of food high in calories without even tasting it. They feel out of control. Stomach pains and the fear of weight gain force them to vomit, use laxatives or exercise excessively. The frequency of such bouts are alarming.

Binge-eating disorder

Its similar to bulimia as patients consume huge amounts of high-calorie food in a short period. The crucial difference is that people with binge eating disorder do not employ purging behaviours to compensate for their binges.

Restrictive food intake

Avoidant/restrictive food intake disorder (ARFID) causes people to eat very less due to a lack of interest in food or an intense distaste for certain foods. This can lead insufficient calorie intake and the lack of nutrition could result in poor development of the body in youngsters.

How some health conditions affect body weight?

Weight loss can be a sign of illness. Some health conditions like hyperthyroidism and diabetes can cause unintentional weight loss. It could also be triggered by cancer, depression, certain infections, bowel diseases among many other ailments.

Hyperthyroidism

Hyperthyroidism occurs when the thyroid gland produces excessive thyroxine (a hormone). Mostly seen in women, an overactive thyroid accelerates body's metabolism, causing unintentional weight loss and a rapid or irregular heartbeat, according to Mayo Clinic.

Diabetes

In people with diabetes, the body fails to produce enough insulin to process the sugar in the bloodstream. So, the body starts burning fat and muscle for energy, causing a reduction in overall body weight.

Real life stories: How some people continue to remain thin

Samir Salama: Food and lifestyle have helped me stay slim

I have always had a body mass index (BMI) of less than 20. [BMI is weight in kilograms divided by the square of height in metres. A BMI of 18.5 24.9 is considered normal or healthy]. I am in good health, and have no medical conditions or eating disorders. My lifestyle plays a major role [in maintaining my weight], Samir Salama, Gulf News Associate Editor based in Abu Dhabi, says.

Genetics does play an important role in determining the body weight. My parents and siblings too are like me. They too dont gain weight easily.

- Samir Salama

Besides genetics, there are other things too. To stay in shape, one has to exercise. It doesnt have to be strenuous activity. When I was young, I used to walk to and from school 15kms a day, and enjoyed working in the field with my grandfather in Egypt. I have been eating a lot of herbs, which we grew ourselves, and many meals are eaten outdoors, or in the fields.

So when I moved to the UAE, I increased the fibre in my diet, which helps make me feel full and is beneficial to the microbiome in the gut. It has an impact on body weight too. In the UAE, my outdoor activities are not the same [as in Egypt]. I dont have the luxury of a garden, but I always get outside and move quite a bit (non-conventional exercise), which is very important. My daily fluid intake has been increased to at least three litres. I also ensure that I get enough sleep, which can impact appetite and metabolism.

I believe sustainable weight loss is a marathon not a sprint. It doesnt do any good if you lose 20kg, then gain it six months later. A good food regimen should be for life, and parents should recommend it to their children.

Mohammad Al Jashi: I tried to put on weight, and failed

People have always been in awe of my metabolism. No matter how much I eat, I can never gain weight, Mohammad Al Jashi, a freelance writer based in Toronto, Canada, says.

I was always fascinated by how quickly my friends put on weight. They end up adopting a stringent dietary regime of salads and no carbohydrates, something I could never wrap my head around since potatoes (crisps) and rice are a daily staples of my nourishment.

- Mohammad Al Jashi

At 57kg, Im very conscious about my lanky physique. I have tried to put on weight. There is one attempt that sticks out in particular: My skinny cousin suggested an appetite stimulant that worked wonders. I became hungry always and my portions grew even larger in size. I still remember how famished I used to be in the morning, to the extent that I would prepare my breakfast before even considering washing my face. It felt like my appetite could never be sated.

I would eat around five to six meals a day for over three months, resulting in the addition of 5.5kg. It was infuriating, because eating became a chore, and meals were no longer enjoyable as it became a means to tamp down the painful rumblings of my tummy.

Then Ramadan rolled along. Once it was over, I hopped onto the scale to find out that I lost my record gain of 5.5kgs. I realised that this is something beyond my control.

To me, gaining weight is difficult, but for my friends weight loss is a commitment that requires plenty of self-control and discipline.

Staying healthy: What the experts say

Suchitra Bajpai Chaudhary, Senior Reporter

While most of us are huffing and puffing on the treadmill, counting calories and resisting our favourite foods, we have some people seem to have their cake and eat it too. In other words, these people not only eat well, but they also dont need to watch the scales. How do they achieve this impossible feat?

Gulf News spoke to a nutritionist, a gastrointestinal specialist and weight loss expert to learn what revs our metabolism. They pin it down to three main factors: behavioural patterns, sound nutrition and genetics.

Dr Fiona Cowie, Weight loss expert

Dr Fiona Cowie, an aesthetician with a certification in advanced weight loss management at the Dermalase Clinic, Jumeirah, Dubai, said weight loss and super-charged metabolism in many people could be due to NEAT. This is Non-Exercise Activity Related Thermogenesis. Some people may not be going to the gym but have an active lifestyle. From cooking, cleaning, looking after the kids, pacing in the office to even fidgeting with a pen, their activity levels can be high, leading to a constant calorie burn. It is estimated that NEAT can boost metabolism up to 50 per cent. Many people might go to the gym but overall follow a sedentary lifestyle.

Two other significant factors are sleep and eating pattern. Our nervous system and our hormones together work in tandem to create an appetite regulatory system. When people dont have good eight hours of sleep at night, it triggers cortisol release because of the stress. This activates the hunger hormone leptin, and they tend to snack a lot and put on weight. Others just have a huge appetite and tend to eat even when they are not hungry. Those with great metabolism are those who sleep well and eat only when hungry, Dr Cowie added.

Mitun De Sarkar, Clinical dietician

Mitun De Sarkar, a clinical dietician with Simply Healthy, Dubai, attributed to the slender physique of some people to mindful eating. While we might see many people eating heavy food, we are not privy to their total eating pattern. These people are likely to balance out their calories for the day. Therefore, even if you saw them eating and drinking at one particular time, they might be eating a light dinner or completely cutting out on snacking. This is behavioural. They are mindful of this behaviour and know how to compensate off the excess calories later.

According to Dr Rajesh Nambiar, specialist gastrointestinal (GI) surgeon from the International Modern Hospital, Dubai, some people are blessed with a good Basal Metabolism Rate (BMR), which helps them burn calories at a faster rate without activity. Of course, BMR can change according to ones lifestyle. However, it is a proven fact that a higher BMR can boost metabolism by up to 15 per cent.

Dr Rajesh Nambiar, Specialist gastrointestinal surgeon

The length of the gut matters a lot. The small intestine is the site where nutrition from food gets assimilated. The small intestine length can vary from 120-180 cm and in taller people; it is usually longer compared to those who are shorter. Taller people tend to have more lean muscle mass and better BMR that allows them to eat and also burn calories faster, Dr Nambiar added.

Other factors that can provide a robust metabolism is regular physical exercise and an active lifestyle. Physical activity, in general, can make a big difference. People who are up and about, always on the move, not necessarily gym freaks but with an active job or new mums chasing their toddlers and busy with household chores, are able to keep their weight off even while snacking around. All these movements rev up the metabolism, increasing the number and activity of mitochondria in the cells. More the mitochondria in your muscles higher the basal metabolic rate of your body, De Sarkar said.

But big eaters who are skinny must check their body composition. If the analysis reveals a higher body fat percentage, high cholesterol and triglyceride levels, it is advisable to cut back on incessant eating and watch what they eat to avoid serious health repercussions, De Sarkar added.

10 tips to manage your weight

Dona Cherian, Assistant Online Editor

Farah Hillou, Integrative and functional nutritionist

Farah Hillou (MS, RD, IFNCP), Integrative and Functional Nutritionist at Chiron Clinic in Dubai gave Gulf News her top ten tips to prevent unhealthy weight gain.

1. Restrict the eating window

Practise time-restricted feeding for at least 14 hours a day. Research has shown that practising time restricted feeding and intermittent fasting can help reduce inflammation, control blood cholesterol and insulin levels, promote autophagy, boost brain health, and help maintain a healthy weight. For instance, dinner can be at 7pm while breakfast the next day is around 9am.

2. Limit snacking

Not only does this prevent grazing and taking in more foods than necessary, but it supports the MMC (migrating motor complex) which optimises digestion.

3. What you eat is crucial

Fill up half of your plates with nutrient-dense, high fibre, colourful vegetables. Include greens like spinach, kale and arugula, as well as cruciferous vegetables like cabbage, broccoli and cauliflower. Add vegetables to your smoothies, soups, and stews.

4. Satiety with proteins and fats

Include protein and/or healthy fats at every meal. This can help with satiety (feeling full) and promotes blood sugar balance. Protein foods include meat, fish, beans, lentils and quinoa while healthy fats include nuts, seeds and avocado.

Avoid foods high in sugar such as cakes, cookies and pastries. Excess sugar can be stored as excess body fat.

5. Support your gut

Studies have shown that an imbalance in gut microbes can stimulate weight gain over time. Add 1 tablespoon of probiotic-rich fermented vegetables such as sauerkraut and kimchi to your meals every day. Moreover, eat prebiotic foods such as garlic and onions to boost healthy gut microbes.

6. Mindful eating

Practise mindful eating by starting with three deep breaths before eating, chewing slowly, and placing your fork down between every few bites. Apply the Japanese proverb Hara Hachi Bu: eat until you are 80 per cent full.

7. Read the labels

Refer to the nutrition facts table and the ingredient list whenever your purchase any packaged foods. Ingredients are listed in order of weight, let go of anything with ingredients you cannot pronounce, and those that have sugar listed in the top few ingredients.

8. Meal planning to deal with cravings

Plan your meals ahead of time and batch cook on weekends. Sudden hunger pangs can have you reach out for anything in sight.

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Why some people never gain weight | Health Gulf News - Gulf News

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SAN DIEGO & WELLESLEY, Mass.--(BUSINESS WIRE)--Illumina, Inc. (Nasdaq: ILMN) and Harvard Pilgrim Health Care announce a risk-sharing agreement to make whole-genome sequencing (WGS) available to certain Harvard Pilgrim members, effective January 1, 2021. The program will leverage WGS to support faster diagnoses of genetic diseases in children, potentially eliminating the long, costly diagnostic odyssey experienced by many families, with the goal of improving patient outcomes.

Diagnosing genetic diseases often takes many years and diagnostic testing costs can exceed $10-20,000 for some patients. Through this agreement, Harvard Pilgrim and Illumina will work together to evaluate how insurance coverage of WGS impacts patient care and healthcare costs. To date, there are more than 20 peer-reviewed publications demonstrating the clinical utility of WGS in over 3,000 patients with suspected genetic diseases. Health economic models predict that implementing WGS earlier in the diagnostic workup is likely to be cost-neutral or even save payers money.

Harvard Pilgrim proudly continues to lead the way in agreements designed to promote access for our members to leading-edge precision medicine technology, while containing costs for consumers and employers. We are delighted to have reached this value-based agreement with Illumina, said Michael Sherman, MD., Harvard Pilgrims Chief Medical Officer. Our members will be able to take advantage of this comprehensive technology, potentially saving themselves enormous frustration, heartache, and financial challenges. Moreover, Illumina gains the opportunity to demonstrate its value in a real-world setting through expanded use of WGS, while Harvard Pilgrim provides additional benefits but deters additional expenses that would otherwise increase costs for our members.

During the term of the agreement, Harvard Pilgrim will cover WGS, through their network of lab providers, for pediatric patients meeting specific criteria. Illumina and Harvard Pilgrim will share the risk on genetic testing costs. Achieving a rapid diagnosis will prove most valuable for allending uncertainty for patient families and potentially halting unnecessary spending on the clinical side. Together, Harvard Pilgrim and Illumina will analyze the data, adjudicate the financials, and prepare a peer-reviewed study for publication.

There are more than 7,000 known genetic conditions, and yet it can take years for patients and their families and physicians to diagnose their conditionfrequently at significant cost in terms of time, money, and emotion, as patients are referred from one specialist to the next, said Ammar Qadan, Vice President of Global Market Access at Illumina. WGS can dramatically reduce the time it takes to diagnose genetic conditions, which can improve patient outcomes, as well as economics.

About Harvard Pilgrim Health Care

Harvard Pilgrim and its family of companies provide health benefit plans, programs, and services to more than 3 million customers in New England and beyond. A leading not-for-profit health services company, we guide our membersand the communities we serveto better health.

Founded by doctors over 50 years ago, were building on our legacy. In partnership with our network of more than 70,000 doctors and 182 hospitals, were improving health outcomes and lowering costs through clinical quality and innovative care management.

Our commitment to the communities we serve is driven by the passion of the Harvard Pilgrim Health Care Foundation. Through its work, low- and moderate-income families are gaining greater access to fresh, affordable fooda cornerstone to better health and well-being. To learn more about Harvard Pilgrim, visit http://www.harvardpilgrim.org.

About Illumina

Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as the global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical, and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture, and other emerging segments. To learn more, visit http://www.illumina.com and connect with us on Twitter, Facebook, LinkedIn, Instagram, and YouTube.

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Illumina and Harvard Pilgrim Health Care Expand Access to Whole-Genome Sequencing for Genetic Disease Testing - Business Wire

Recommendation and review posted by Bethany Smith

There is a common misconception that many genetic diseases are more common in Western countries than in India. For some, this has translated to an almost total disregard for some of the most common and deadly diseases in India.

A study conducted by MedGenome Labs, in partnership with Sir Ganga Ram Hospital in New Delhi, has found that, not only are disease-related genes more common in India than previously expected, they vary from those found in Western nations.

The study is, unfortunately, of limited scope, assessing a sample size of 200 unrelated individuals in the north Indian population over a period of 22 months. Of the 200 participants, 52 (26 percent) were found to be carriers of one or more rare genetic disorders. The title of rare disease in this regard is at least partially misleading. An estimated one in twenty Indians suffer from illnesses that fall under the classification of rare diseases. Children account for fifty percent of such cases.

Rare diseases affect around 350 million people worldwide. This figure includes roughly seventy million Indians. Each disease may individually affect just a few hundred, or a few thousand worldwide many affect even less. The sheer number of different conditions that fall under the umbrella term of rare diseases, however, means that cumulatively these conditions affect hundreds of millions. Funding for each individual disease is often all but non-existent due to the limited impact of funding research into a disease affecting so few people.

Three percent of individuals within the survey were found to be carriers for Pompe disease, a rare genetic condition that impacts muscle function. This often leads to issues with both breathing and eating. This is a high rate that could indicate the Indian population to be far more vulnerable than others. However, due to the limited scope of the study, this could be an overestimate due to the small sampling size, warranting further investigations on a broader scale.

Other notable discoveries from the study indicated a statistical difference in the disease causing variants observed for disorders such as deafness, cystic fibrosis, Canavan disease, primary hyperoxaluria, junctional epidermolysis bullosa, galactosemia, and medium chain acyl CoA deficiency compared to Western populations.

Dr Sunita Bijarnia-Mahay, author and senior consultant at Sir Ganga Ram Hospitals Institute of Medical Genetics & Genomics, said this study brought surprises by detecting those genetic disorders like cystic fibrosis which were not thought to be common. In future, such next generation sequencing (NGS)-based screening tests will bring benefit to not only the young couples who would be planning a baby, but also the healthcare officials in charting out the prevention strategies for our Indian population.

According to Dr Sheetal Sharda, a senior consultant in clinical genetics at MedGenome Labs in Bengaluru, couples may not even be aware that they could be carrying a genetic variant, which could lead to their unborn child developing a genetic disorder. In most cases, carriers of a genetic disorder are asymptomatic and may have no family history and unfortunately their carrier status is often confirmed only after an affected baby is born.

More genetic study is warranted within the Indian population. India represents almost twenty percent of the worlds population and is on track to become the worlds most populous nation in the coming decades. Despite this, only 0.2 percent of fully mapped genomes in global databanks are of Indian origin.

Success has been had in the past regarding genetic studies of the Indian population. One Genome Wide Association Study (GWAS) found that there are six unique alleles present among the Indian population that causes a genetic predisposition to diabetes. This underlines at least part of the cause of high diabetes rates among Indians other causes being lifestyle factors such as diets rich in sugar and sedentary lifestyles with a limited degree of exercise.

Genetics form an underlying component of disease that interacts in a complex manner with environmental factors and lifestyle choices to create a risk factor for many of Indias most common and life-threatening diseases. Diabetes is just one example. Heart disease Indias most common cause of death is another.

Knowledge of unique, or common genetic risk factors among Indias population is vital to shaping health programmes tailored to Indias population. With greater knowledge, and greater availability of genetic testing, countless lives could be saved by providing early warning of potentially life-threatening diseases.

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Genetic disease in India: more prevalent than previously thought? - Hyderus Cyf

Recommendation and review posted by Bethany Smith