The global CNS Gene Therapy market study encloses the projection size of the market both in terms of value (Mn/Bn US$) and volume (x units). With bottom-up and top-down approaches, the report predicts the viewpoint of various domestic vendors in the whole market and offers the market size of the CNS Gene Therapy market. The analysts of the report have performed in-depth primary and secondary research to analyze the key players and their market share. Further, different trusted sources were roped in to gather numbers, subdivisions, revenue and shares.

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The global CNS Gene Therapy market research considers region 1 (Country 1, country 2), region 2 (Country 1, country 2) and region 3 (Country 1, country 2) as the important segments. All the recent trends, such as changing consumers demand, ecological conservation, and regulatory standards across different regions are covered in the report.

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CNS Gene Therapy Market Is Likely To Attain A Market Value Of US$ XX Mn/Bn In 2018 2028 - The Daily Chronicle

Recommendation and review posted by Bethany Smith

Cell and Gene Therapy Market Research Report is a Proficient and In-Depth Study on the Existing State of Cell and Gene Therapy Industry. This Report Focuses on the Major Drivers, Restraints, Opportunities and Threats for Key Players. It also Provides Granular Analysis of Market Share, Segmentation, Revenue Forecasts and Regional Analysis till 2025.

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City of Hope, a world-renowned independent research and treatment center for cancer, diabetes and other life-threatening diseases, today announced that it has licensed intellectual property relating to its pioneering chlorotoxin chimeric antigen receptor (CLTX-CAR) T cell therapy to Chimeric Therapeutics Limited, an Australian biotechnology company.

The therapy is currently being used in a phase 1 clinical trial at City of Hope to treat glioblastoma (GBM), a type of brain tumor. The first patient in the trial was recently dosed; Behnam Badie, M.D., chief of City of Hopes Division of Neurosurgery and The Heritage Provider Network Professor in Gene Therapy, is leading this innovative, first-of-its-kind trial.

Chimeric has acquired the exclusive worldwide rights to develop and commercialize certain patents relating to City of Hopes CLTX-CAR T cells, as well as to further develop the therapy for other cancers.

City of Hope is excited to enter into this agreement with Chimeric as it supports our innovative research in CAR T cell therapy and our commitment to extend these therapies to more patients, particularly those with GBM and other solid tumors that are difficult to treat, said Christine Brown, Ph.D., The Heritage Provider Network Professor in Immunotherapy and deputy director of City of Hopes T Cell Therapeutics Research Laboratory. Chimeric shares our goal of providing effective CAR T cell therapies to more patients with current unmet medical needs.

Led by Brown and Michael Barish, Ph.D., chair of City of Hopes Department of Developmental and Stem Cell Biology, and Dongrui Wang, Ph.D., a recent graduate of City of Hopes Irell & Manella Graduate School of Biological Sciences, the team developed and tested the first CAR T cell therapy using CLTX, a component of scorpion venom, to direct T cells to target brain tumor cells. The research was published this past March in Science Translational Medicine.

Chimeric is excited to join City of Hope in its quest to find more effective cancer therapies. This is an exceedingly rare opportunity to acquire a promising technology in one of the most exciting areas of immuno-oncology today, said Paul Hopper, executive chairman of Chimeric.

Furthermore, the CLTX-CAR T cell therapy has completed years of preclinical research and development, and recently enrolled its first patient in a phase 1 clinical trial for brain cancer.CARs commonly incorporate a monoclonal antibody sequence in their targeting domain, enabling CAR T cells to recognize antigens and kill tumor cells. In contrast, the CLTX-CAR uses a synthetic 36-amino acid peptide sequence first isolated from death stalker scorpion venom and now engineered to serve as the CAR recognition domain.

In this recent study, City of Hope researchers used tumor cells in resection samples from a cohort of patients with GBM to compare CLTX binding with expression of antigens currently under investigation as CAR T cell targets. They found that CLTX bound to a greater proportion of patient tumors, and cells within these tumors.

CLTX binding included the GBM stem-like cells thought to seed tumor recurrence. Consistent with these observations, CLTX-CAR T cells recognized and killed broad populations of GBM cells while ignoring nontumor cells in the brain and other organs. The study team demonstrated that CLTX-directed CAR T cells are highly effective at selectively killing human GBM cells without off-tumor targeting and toxicity in cell-based assays and in animal models.

City of Hope, a recognized leader in CAR T cell therapies for GBM and other cancers, has treated more than 500 patients since its CAR T program started in the late 1990s. The institution continues to have one of the most comprehensive CAR T cell clinical research programs in the world it currently has 30 ongoing CAR T cell clinical trials, including CAR T cell trials for HER-2 positive breast cancer that has spread to the brain, and PSCA-positive bone metastatic prostate cancer. It was the first and only cancer center to treat GBM patients with CAR T cells targeting IL13R2, and the first to administer CAR T cell therapy locally in the brain, either by direct injection at the tumor site, through intraventricular infusion into the cerebrospinal fluid, or both. In late 2019, City of Hope opened a first-in-human clinical trial for patients with recurrent GBM, combining IL13R2-CAR T cells with checkpoint inhibitors nivolumab, an anti-PD1 antibody, and ipilimumab, blocking the CTLA-4 protein.

Both an academic medical center and a drug development powerhouse, City of Hope is known for creating the technology used in the development of human synthetic insulin and numerous breakthrough cancer drugs. Its unique research and development hybrid of the academic and commercial creates an infrastructure that enables City of Hope researchers to submit an average of 50 investigational new drug applications to the U.S. Food and Drug Administration each year. The institution currently holds more than 450 patent families.

"City of Hope is delighted to license this technology to Chimeric, said Sangeeta Bardhan Cook, Ph.D., City of Hope director of the Office of Technology Licensing. We are impressed with the ability of their executive team to push and bring therapies to market expeditiously. At City of Hope, our mission is to transform the future of health care. We believe Chimeric has the vision to offer innovative therapies to cancer patients.

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City of Hope enters licensing agreement with Chimeric to develop its pioneering chlorotoxin CAR T cell therapy - OncLive

Recommendation and review posted by Bethany Smith

LONDONandNEW YORK, Sept. 22, 2020 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc(Nasdaq: MGTX), a vertically integrated, clinical stage gene therapy company, today announced nine-month results from the ongoing Phase 1/2 clinical trial(NCT03252847) of AAV-RPGR, an investigational gene therapy for the treatment of X-linked retinitis pigmentosa (XLRP), will be presented in an oral session at the EURETINA 2020 Virtual Meeting taking place October 2-4, 2020.

Details of the presentation are listed below. Data is embargoed until the date and time of presentation.

Title: Phase 1/2 Clinical Trial of AAV-RPGR Gene Therapy for RPGR-Associated X-Linked Retinitis Pigmentosa: 9-month ResultsPresenter: Michel Michaelides, BSc MB BS MD(Res) FRCOphth FACSDate and Time: Saturday, October 3, 10:45am EDT (4:45pm CEST)Session: EURETINA Session 11: Late Breaking & Reviews

MeiraGTx and Janssen Pharmaceuticals, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, are jointly developing AAV-RPGR as part of a broader collaboration to develop and commercialize gene therapies for the treatment of inherited retinal diseases.

In July 2020, MeiraGTx announced six-month data from the ongoing Phase 1/2 MGT009 clinical trial, which demonstrated AAV-RPGR was generally well tolerated and produced significant improvement in vision in the dose escalation phase of the trial.

About AAV-RPGRAAV-RPGR is an investigational gene therapy for the treatment of patients with X-Linked Retinitis Pigmentosa (XLRP) caused by mutations in the eye specific form of theRPGRgene (RPGRORF15). AAV-RPGR is designed to deliver functional copies of theRPGRgene to the subretinal space in order to improve and preserve visual function.MeiraGTxand development partner Janssen are currently conducting a Phase 1/2 clinical trial of AAV-RPGR in patients with XLRP with mutations inRPGRORF15. AAV-RPGR has been granted Fast Track and Orphan Drug designations by theU.S. Food and Drug Administration(FDA) and PRIME, ATMP and Orphan designations by theEuropean Medicines Agency (EMA).

About the Phase 1/2 MGT009 Clinical TrialMGT009 is a multi-center, open-label Phase 1/2 trial (NCT03252847) of AAV-RPGR gene therapy for the treatment of patients with XLRP associated with disease-causing variants in theRPGRgene. MGT009 consists of three phases: dose-escalation, dose-confirmation, and dose-expansion. Each patient was treated with subretinal delivery of AAV-RPGR in the eye that was more affected at baseline. The patients other eye served as an untreated control. In dose-escalation (n=10), adults were administered low, intermediate, or high dose AAV-RPGR. The primary endpoint was safety. Visual function was assessed at baseline, three, six, nine and 12 months with Octopus 900 full-field static perimetry and mesopic fundus-guided microperimetry (MP); mean retinal sensitivity, visual field modeling and analysis (VFMA; Hill-of-vision volumetric measure), and pointwise comparisons were examined.

About X-Linked Retinitis Pigmentosa (XLRP)XLRP is the most severe form of retinitis pigmentosa (RP), a group of inherited retinal diseases characterized by progressive retinal degeneration and vision loss. In XLRP, both rods and cones function poorly, leading to degeneration of the retina and total blindness. The most frequent cause of XLRP is disease-causing variants in theRPGRgene, accounting for more than 70% of cases of XLRP, and up to 20% of all cases of RP. There are currently no approved treatments for XLRP.

AboutMeiraGTxMeiraGTx(Nasdaq: MGTX) is a vertically integrated, clinical stage gene therapy company with six programs in clinical development and a broad pipeline of preclinical and research programs.MeiraGTx has core capabilities in viral vector design and optimization and gene therapy manufacturing, as well as a potentially transformative gene regulation technology. Led by an experienced management team,MeiraGTxhas taken a portfolio approach by licensing, acquiring and developing technologies that give depth across both product candidates and indications. MeiraGTxs initial focus is on three distinct areas of unmet medical need: inherited retinal diseases, neurodegenerative diseases and severe forms of xerostomia. Though initially focusing on the eye, central nervous system and salivary gland,MeiraGTxintends to expand its focus in the future to develop additional gene therapy treatments for patients suffering from a range of serious diseases.

For more information, please visitwww.meiragtx.com.

Forward Looking StatementThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding the development and efficacy of AAV-RPGR, plans to advance AAV-RPGR into Phase 3 clinical trial and anticipated milestones regarding our clinical data and reporting of such data and the timing of results of data, including in light of the COVID-19 pandemic, as well as statements that include the words expect, intend, plan, believe, project, forecast, estimate, may, should, anticipate and similar statements of a future or forward-looking nature. These forward-looking statements are based on managements current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, our incurrence of significant losses; any inability to achieve or maintain profitability, acquire additional capital, identify additional and develop existing product candidates, successfully execute strategic priorities, bring product candidates to market, expansion of our manufacturing facilities and processes, successfully enroll patients in and complete clinical trials, accurately predict growth assumptions, recognize benefits of any orphan drug designations, retain key personnel or attract qualified employees, or incur expected levels of operating expenses; the impact of the COVID-19 pandemic on the status, enrollment, timing and results of our clinical trials and on our business, results of operations and financial condition; failure of early data to predict eventual outcomes; failure to obtain FDA or other regulatory approval for product candidates within expected time frames or at all; the novel nature and impact of negative public opinion of gene therapy; failure to comply with ongoing regulatory obligations; contamination or shortage of raw materials or other manufacturing issues; changes in healthcare laws; risks associated with our international operations; significant competition in the pharmaceutical and biotechnology industries; dependence on third parties; risks related to intellectual property; changes in tax policy or treatment; our ability to utilize our loss and tax credit carryforwards; litigation risks; and the other important factors discussed under the caption Risk Factors in our Quarterly Report on Form 10-Q for the quarter endedMarch 31, 2020, as such factors may be updated from time to time in our other filings with theSEC, which are accessible on the SECs website atwww.sec.gov. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent managements estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, unless required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Thus, one should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

Contacts

Investors:MeiraGTxElizabeth (Broder) Anderson (646) 860-7983elizabeth@meiragtx.com

Or

Media:W2O pureChristiana Pascale(212) 257-6722cpascale@purecommunications.com

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MeiraGTx Announces Data from Ongoing Clinical Trial of AAV-RPGR for the Treatment of X-Linked Retinitis Pigmentosa to be Presented at EURETINA 2020...

Recommendation and review posted by Bethany Smith

HEIDELBERG, Germany, Sept. 21, 2020 /PRNewswire/ -- GeneWerk GmbH, a cell and gene therapy testing laboratory focused on providing preclinical and clinical trial patient sample analysis services, today announced a majority investment from Ampersand Capital Partners, a private equity firm specializing in growth equity investments in the healthcare sector. Ampersand's growth investment will be used to expand GeneWerk's capabilities to meet rapidly growing demand for cell and gene therapy testing services.

GeneWerk provides cell and gene therapy sponsors with patient testing services in compliance with guidance by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The company is recognized as a leading provider of vector integration site analysis (ISA) services, a method that was developed by GeneWerk's founders and that the FDA and EMA recommend performing after the administration of both integrating and non-integrating cell and gene therapies. The company's test menu also includes vector persistence testing, gene edited off-target analysis, vector copy number (VCN), vector quality control, immune repertoire analysis, and dedicated bioinformatics studies. With a focus on vector safety, characterization, and functionality analysis, the company's 30 employees work in compliance with GCP and in line with GLP standards in a BSL-2 classified state-of-the-art genomics and bioinformatics laboratory in Heidelberg, Germany.

Annette Deichmann, Ph.D., Co-Founder and Co-CEO at GeneWerk commented, "With the benefit of Ampersand as our partner, GeneWerk will strengthen and expand its position in the U.S. and European markets while further investing in our testing capabilities to service cell and gene therapy sponsors and patients." Co-Founder and Co-CEO Manfred Schmidt, Ph.D., then added, "Our partnership with Ampersand solidifies GeneWerk's position in the space and will allow the company to continue to exceed our customers' expectations by facilitating the development of innovative cell and gene therapies. We are very pleased to have Ampersand on board as we take GeneWerk through its next phase of growth." Christof von Kalle, M.D., Co-Founder concluded, "This will greatly further GeneWerk's opportunities to contribute to medical breakthroughs and patient safety."

Marina Pellon-Consunji, Principal at Ampersand said, "GeneWerk is a leading company in its field. Given the exciting developments within the cell and gene therapy market and recent guidance by FDA and EMA, this is an excellent time for an investor with deep experience in cell and gene therapy to partner with the company. We are looking forward to working with the team at GeneWerk to accelerate and continue its success in delivering leading testing services to ensure the safety of patients receiving cutting edge cell and gene therapies."

About GeneWerk GmbHFounded in 2014 by Prof. Dr. Christof von Kalle, Dr. Manfred Schmidt, and Dr. Annette Deichmann with the participation of the German Cancer Research Center (DKFZ) Heidelberg, GeneWerk is a cell and gene therapy testing laboratory focused on providing preclinical and clinical trial patient sample analysis services. The company is recognized as a leading provider of vector integration site analysis (ISA) services, a method that was developed by the company's founders and that the FDA and EMA recommend performing after the administration of both integrating and non-integrating cell and gene therapies. For more information, please visit http://www.genewerk.com.

About Ampersand Capital PartnersFounded in 1988, Ampersand is a middle market private equity firm dedicated to growth-oriented investments in the healthcare sector. With offices in Boston and Amsterdam, Ampersand leverages its unique blend of private equity and operating experience to build value and drive superior long-term performance alongside its portfolio company management teams. Ampersand has helped build numerous market-leading companies across each of the firm's core healthcare sectors. Additional information about Ampersand is available at http://www.ampersandcapital.com.

SOURCE Ampersand Capital Partners

http://www.ampersandventures.com

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GeneWerk GmbH Announces Growth Equity Investment from Ampersand Capital Partners - PRNewswire

Recommendation and review posted by Bethany Smith

PARIS--(BUSINESS WIRE)--Regulatory News:

GenSight Biologics (Paris:SIGHT) (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today reported that statistical analysis of pooled data from LUMEVOQ trials and natural history studies found a statistically significant and clinically meaningful difference between the visual outcomes in LUMEVOQ-treated patients and untreated patients.

Treated eyes showed progressive and sustained improvement from Month 12 to Month 52, in contrast to the absence of recovery over the same period for untreated eyes. At Month 18, the difference became statistically significant (p=0.01). By Month 48, the difference between the mean visual acuity in treated patients and that in untreated patients was both statistically significant (p<0.01) and clinically meaningful (-0.33 LogMAR, or +16.5 ETDRS letters equivalent, in favor of treated eyes).

Note: All patients had a confirmed G11778A mutation in the ND4 mitochondrial gene and were at least 15 years old. The diagram shows the Locally Estimated Scatterplot Smoothing (LOESS) curves for visual acuity in LUMEVOQ-treated patients and untreated patients. The shaded areas represent the 95% confidence interval for the mean BCVA. Treated eyes refer to all eyes (LUMEVOQ and sham) from the RESCUE, REVERSE and CLIN06 trials (N=76 patients / 152 eyes). Untreated eyes refer to patient-level data from the REALITY study and a matched data set from two prospective and eight retrospective natural history studies1 (N=208 patients / 408 eyes). LOESS curves were estimated using a non-parametric, local regression model that treated each eye as independent of the other. LOESS curves are shown from Month 12 to depict post-treatment progression among treated patients (93% of LUMEVOQ patients had already been treated within 12 months from onset). *Statistically significant difference between mean visual acuity of treated and untreated eyes at M18, M24, M36 and M48, as illustrated by the non-overlapping confidence intervals.

The analysis compared data from the completed Phase III trials RESCUE and REVERSE studies and interim results from the long-term follow-up CLIN06 study to a matched sample created from the REALITY registry study and 10 other natural history studies1. The natural history studies were identified from an extensive review of the scientific literature and selected based on specific inclusion criteria for their patient-level data. In all, the visual outcomes in 76 treated patients could be compared to the visual outcomes of 208 untreated patients.

The extra granularity of this analysis down to individual patient data confirms that the natural history of visual outcomes in ND4-LHON patients is poor and provides the best comparison we have for assessing the therapeutic efficacy of gene therapy, commented Dr. Nancy J. Newman, MD, LeoDelle Jolley Professor of Ophthalmology and Neurology at the Emory University School of Medicine in Atlanta, GA, USA, and a global authority on LHON who recently completed a meta-analysis of the natural history of ND4-LHON.2

Separate analyses of patients enrolled in RESCUE and REVERSE demonstrated similarly favorable results compared to untreated patients. Full findings from the indirect comparison were included in the European Marketing Authorisation Application (MAA) for LUMEVOQ and are being prepared for publication in a peer-reviewed journal.

This indirect comparison represents a significant contribution to our understanding of LUMEVOQs therapeutic effect," said Dr. Jos-Alain Sahel, MD, Director of the Institut de la Vision (Sorbonne-Universit/Inserm/CNRS), Paris, France; Chairman of the Department of Ophthalmology at Centre Hospitalier National dOphtalmologie des XV-XX, Paris, France; Professor and Chairman of the Department of Ophthalmology at University of Pittsburgh School of Medicine and UPMC (University of Pittsburgh Medical Center), USA; and Co-Founder of GenSight Biologics. The use of a large external control group, including analyses of patient-level data, provides more evidence for a significant treatment-related visual improvement.

The findings are a gratifying outcome of our push to overcome a key challenge for assessing LUMEVOQs efficacy, namely the inability of sham eyes to act as a control group, commented Bernard Gilly, Co-founder and Chief Executive Officer of GenSight. We are excited to take this evidence that LUMEVOQ modifies the disease outcome forward into our conversations with national and regional authorities.

The LUMEVOQ MAA was filed in September, and the decision is expected in H2 2021. The Company is also working towards submitting LUMEVOQs Biologics License Application (BLA) to the FDA in H2 2021.

GenSight will host a conference call today, September 21, 2020, at 10am CEST in French, and at 2.00pm CEST (8.00am EST) in English, to discuss these results.

Webcast & Conference call in French (10am CEST)

Dial-in numbers:

United States: +1 212 999 6659France: +33 (0)1 7037 7166United Kingdom: +44 (0)20 3003 2666Password: GenSight FR

Webcast link: https://bit.ly/3mAS0Vy

Webcast & Conference call in English (2.00pm CEST / 8.00am EST)

Dial-in numbers:

United States: +1 212 999 6659France: +33 (0) 1 7037 7166United Kingdom: +44 (0) 20 3003 2666Password: GenSight ENG

Webcast link: https://bit.ly/35RCfnl

A replay of the calls and webcasts will be available by using the above links.

Rationale for the Indirect Comparison

In both the REVERSE and RESCUE studies, as well as in the long-term follow-up study CLIN06, unilaterally injected patients experienced an unexpected visual improvement in their contralateral eye, which mirrored the sustained and clinically relevant gain in eyes treated with LUMEVOQ. This bilateral improvement eliminated the control group that was to consist of sham eyes in the original trial design. An indirect comparison methodology, based on formal statistical methods applied to an external control group, was needed to assess the magnitude of LUMEVOQ efficacy.

Methodology Highlights

The sample of LUMEVOQ-treated patients included all data from the two pivotal studies REVERSE and RESCUE and Year 3 data from the ongoing extension study CLIN06. This approach yielded a treated patient pool consisting of 76 patients (152 eyes), with LUMEVOQ-injected eyes and sham-treated eyes considered equivalent, based on the contralateral effect demonstrated in the studies.

The external control group included data from the REALITY Natural History registry and patient-level data from 10 published articles1 on ND4-LHON, which were identified from a systematic review of the literature. ND4-LHON studies were included in the indirect comparison only if they had individual patient data that would allow indirect comparison with LUMEVOQ-treated patients: confirmed ND4 genotype, at least 15 years of age, at least one BCVA measurement with associated time of vision loss. The final external control group included 208 patients (408 eyes).

The visual acuity curves of treated and untreated patients were defined using a Locally Estimated Scatterplot Smoothing (LOESS), non-parametric, local regression model. They were aligned in terms of time from vision loss for the statistical tests performed at M12, M18, M24, M36 and M48 from vision loss and at the last available observation. The starting time point for the statistical tests (12 months post-vision loss) was defined to enable assessment of LUMEVOQ efficacy, as 93% of LUMEVOQ patients were treated by that time.

1The 10 studies that passed the inclusion criteria were: Hotta 1995, Lam 2014, Nakamura 1993, Newman 1991, Qu 2007, Qu 2009, Romero 2014, Sadun 2004, Yang 2016, and Zhou 2010.

2Newman NJ, Carelli V, Taiel M and Yu-Wai Man P. Visual outcomes in Leber hereditary optic neuropathy patients with the m.11778G>A (MTDN4) mitochondrial DNA mutation. J Neuro-Ophthalmol. In Press. 2020.

About GenSight Biologics

GenSight Biologics S.A. is a clinical-stage biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders. GenSight Biologics pipeline leverages two core technology platforms, the Mitochondrial Targeting Sequence (MTS) and optogenetics, to help preserve or restore vision in patients suffering from blinding retinal diseases. GenSight Biologics lead product candidate, LUMEVOQ (GS010; lenadogene nolparvovec), has been submitted for marketing approval in Europe for the treatment of Leber Hereditary Optic Neuropathy (LHON), a rare mitochondrial disease affecting primarily teens and young adults that leads to irreversible blindness. Using its gene therapy-based approach, GenSight Biologics product candidates are designed to be administered in a single treatment to each eye by intravitreal injection to offer patients a sustainable functional visual recovery.

About LUMEVOQ (GS010)

LUMEVOQ (GS010) targets Leber Hereditary Optic Neuropathy (LHON) by leveraging a mitochondrial targeting sequence (MTS) proprietary technology platform, arising from research conducted at the Institut de la Vision in Paris, which, when associated with the gene of interest, allows the platform to specifically address defects inside the mitochondria using an AAV vector (Adeno-Associated Virus). The gene of interest is transferred into the cell to be expressed and produces the functional protein, which will then be shuttled to the mitochondria through specific nucleotidic sequences in order to restore the missing or deficient mitochondrial function. LUMEVOQ was accepted as the invented name for GS010 (lenadogene nolparvovec) by the European Medicines Agency (EMA) in October 2018.

About Leber Hereditary Optic Neuropathy (LHON)

Leber Hereditary Optic Neuropathy (LHON) is a rare maternally inherited mitochondrial genetic disease, characterized by the degeneration of retinal ganglion cells that results in brutal and irreversible vision loss that can lead to legal blindness, and mainly affects adolescents and young adults. LHON is associated with painless, sudden loss of central vision in the 1st eye, with the 2nd eye sequentially impaired. It is a symmetric disease with poor functional visual recovery. 97% of patients have bilateral involvement at less than one year of onset of vision loss, and in 25% of cases, vision loss occurs in both eyes simultaneously. The estimated incidence of LHON is approximately 1,400 to 1,500 new patients who lose their sight every year in the United States and Europe.

About RESCUE and REVERSE

RESCUE and REVERSE are two separate randomized, double-masked, sham-controlled Phase III trials designed to evaluate the efficacy of a single intravitreal injection of GS010 (rAAV2/2-ND4) in subjects affected by LHON due to the G11778A mutation in the mitochondrial ND4 gene.

The primary endpoint measures the difference in efficacy of GS010 in treated eyes compared to sham-treated eyes based on BestCorrected Visual Acuity (BCVA), as measured with the ETDRS at 48 weeks post-injection. The patients LogMAR (Logarithm of the Minimal Angle of Resolution) scores, which are derived from the number of letters patients read on the ETDRS chart, will be used for statistical purposes. Both trials have been adequately powered to evaluate a clinically relevant difference of at least 15 ETDRS letters between treated and untreated eyes adjusted to baseline.

The secondary endpoints involve the application of the primary analysis to bestseeing eyes that received GS010 compared to those receiving sham, and to worseseeing eyes that received GS010 compared to those that received sham. Additionally, a categorical evaluation with a responder analysis was evaluated, including the proportion of patients who maintain vision (< ETDRS 15L loss), the proportion of patients who gain 15 ETDRS letters from baseline and the proportion of patients with Snellen acuity of >20/200. Complementary vision metrics include automated visual fields, optical coherence tomography, and color and contrast sensitivity, in addition to quality of life scales, biodissemination and the time course of immune response. Readouts for these endpoints are at 48, 72 and 96 weeks after injection.

The trials were conducted in parallel, in 37 subjects for REVERSE and 39 subjects for RESCUE, in 7 centers across the United States, the UK, France, Germany and Italy. Week 96 results were reported in 2019 for both trials, after which patients were transferred to a long-term follow-up study that will last for three years.

ClinicalTrials.gov Identifiers:REVERSE: NCT02652780RESCUE: NCT02652767

About CLIN06 (RESCUE and REVERSE Long-term Follow-up)

CLIN06 is the long-term follow-up study of ND4 LHON subjects treated with LUMEVOQ (GS010) gene therapy in the RESCUE or REVERSE Phase III Clinical Trials. The total study period for an individual subject is 3 years, i.e., 5 years post-gene therapy administration. No study treatment is administered during CLIN06.

The primary objective is to assess the long-term safety of intravitreal LUMEVOQ administration up to 5 years post-treatment. The secondary objective is to assess the long-term treatment efficacy of the therapy and the quality of life (QoL) in subjects up to 5 years post-treatment. The first subject was enrolled on January 9, 2018. 61 subjects have enrolled.

ClinicalTrials.gov Identifiers:CLIN06: NCT03406104

About REALITY

REALITY is a multi-country retrospective and cross-sectional observational study of affected LHON subjects, based on subjects medical charts and the administration of surveys on Health-Related Quality of Life (HRQoL) and direct and indirect costs associated with the disease.

The study aimed to recruit at least 50 subjects (both adult and pediatric) chiefly in the following countries: Spain, Italy, France, United Kingdom and the United States.

The primary objectives for the REALITY study were: to describe the evolution of visual functional and structural changes and other associated symptoms in patients with LHON; understand the impact of LHON-related vision loss on the HRQoL; and understand the economic burden for patients and their families arising from direct and indirect costs associated with the disease. The secondary objective is to describe the relationship between genetic, lifestyle and/or environmental factors and the expression of the LHON phenotype.

The first subject was enrolled on 3 January 2018. Enrollment was completed in early Q2 2020.

ClinicalTrials.gov Identifiers:REALITY LHON Registry: NCT03295071

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GenSight Biologics Reports New Analysis Demonstrating Statistically Significant and Clinically Meaningful Difference Between Visual Outcomes in...

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DetailsCategory: AntibodiesPublished on Tuesday, 22 September 2020 10:41Hits: 257

Adjuvant Opdivo doubled disease-free survival; is the first therapeutic option to show statistically significant and clinically meaningful disease-free survival benefit in these patients, regardless of tumor histology, following chemoradiation therapy and resection

Results from Phase 3 CheckMate -577 trial selected for presentation during a Presidential Symposium at the European Society for Medical Oncology Virtual Congress 2020

PRINCETON, NJ, USA I September 21, 2020 I Bristol Myers Squibb (NYSE: BMY) today announced first results from the Phase 3 CheckMate -577 trial in which adjuvant treatment with Opdivo (nivolumab) showed a statistically significant and clinically meaningful improvement in disease-free survival (DFS), the trials primary endpoint, compared to placebo in patients with esophageal or gastroesophageal junction (GEJ) cancer following neoadjuvant chemoradiation therapy (CRT) and tumor resection. The current standard of care for patients with esophageal or GEJ cancer following neoadjuvant CRT and tumor resection is surveillance. These results signify the first time an adjuvant therapeutic option has significantly prolonged DFS for patients in this setting.

Median DFS was doubled in patients receiving Opdivo [22.4 months; (95% Confidence Interval [CI]: 16.6 to 34.0)] compared to those receiving placebo after surgery [11.0 months; (95% CI: 8.3 to 14.3)] (Hazard Ratio [HR] 0.69; 96.4% CI: 0.56 to 0.86; p=0.0003). The median duration of treatment for patients in the Opdivo arm was just over 10 months [10.1 months (<0.1 to 14.2)] versus nine months for patients in the placebo arm [9.0 months (<0.1 to 15)]. The safety profile of Opdivo in CheckMate -577 was consistent with previously reported studies of Opdivo monotherapy.

While about 25% to 30% of patients with esophageal or gastroesophageal junction cancer achieve a complete response following chemoradiation therapy and surgery, the remaining 70% to 75% do not, and there is currently no adjuvant treatment option available for these patients with the potential to improve their outcomes, said Ronan J. Kelly M.D., MBA, Director, Charles A. Sammons Cancer Center at Baylor University Medical Center. Adjuvant treatment with nivolumab in the CheckMate -577 trial doubled patients time without disease recurrence, representing the first adjuvant treatment advancement for these patients with esophageal or gastroesophageal junction cancer.

Opdivo was well tolerated with an acceptable safety profile relative to placebo. The majority of patients in the Opdivo arm (89%) were able to receive a relative dose intensity of 90%. The incidence of any treatment-related adverse events (TRAEs), including any grade and Grade 3-4, was 71% and 13% among patients treated with Opdivo compared to 46% and 6% among patients receiving placebo. Serious TRAEs of any grade and Grade 3-4 occurred in less than 10% of patients treated with Opdivo (any grade in 8%, Grade 3-4 in 5%) compared to 3% and 1% of patients receiving placebo, with a low rate of any grade treatment-related discontinuations in both arms (9% for Opdivo vs. 3% in placebo).

These results make esophageal and gastroesophageal junction cancer the second cancer type following melanoma where Opdivo has demonstrated a benefit in the adjuvant setting, indicating the potential for Opdivo to become a new standard of care for these patients, said Ian M. Waxman, M.D., development lead, Gastrointestinal Cancers, Bristol Myers Squibb. This advancement showcases our commitment to evaluating our therapies in earlier stages of disease where we may be able to have a greater impact on preventing disease recurrence and improving patient outcomes. We look forward to discussing these encouraging results from CheckMate -577 with global health authorities in the coming months.

These data (Presentation #LBA9) will be featured in a Presidential Symposium at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 on September 21 from 19:31-19:43 CEST.

About CheckMate -577

CheckMate -577 is a Phase 3 randomized, multi-center, double-blind study evaluating Opdivo as an adjuvant therapy in patients with resected esophageal or GEJ cancer who have received neoadjuvant CRT therapy and have not achieved a pathological complete response. The primary endpoint of the trial is DFS and the secondary endpoint is overall survival (OS). Following neoadjuvant CRT therapy and complete tumor surgical resection (also known as trimodality therapy), a total of 794 patients were randomized to receive placebo (n=262) or Opdivo (n=532) 240 mg by intravenous infusion every two weeks for 16 weeks followed by Opdivo 480 mg every four weeks until disease recurrence, unacceptable toxicity or withdrawal of consent, with a maximum of one year total treatment duration.

About Esophageal Cancer

Esophageal cancer is the seventh most common cancer and the sixth leading cause of death from cancer worldwide, with approximately 572,000 new cases and over 508,000 deaths in 2018. The two most common types of esophageal cancer are squamous cell carcinoma and adenocarcinoma, which account for approximately 85% and 15% of all esophageal cancers, respectively, though esophageal tumor histology can vary by region with the highest rate of esophageal adenocarcinoma occurring in North America (65%). The majority of cases are diagnosed in the advanced setting and impact a patients daily life, including their ability to eat and drink.

About Gastric Cancer

Gastric cancer, also known as stomach cancer, is the fifth most common cancer and the third leading cause of cancer death worldwide, with over 1,000,000 new cases and approximately 783,000 deaths in 2018. There are several cancers that can be classified as gastric cancer, including certain types of cancers that form in the GEJ, the area of the digestive tract where the esophagus and stomach connect. While GEJ cancer has a lower prevalence than gastric cancer, it continues to rise.

Bristol Myers Squibb: Advancing Cancer Research

At Bristol Myers Squibb, patients are at the center of everything we do. The goal of our cancer research is to increase patients quality of life, long-term survival and make cure a possibility. We harness our deep scientific experience, cutting-edge technologies and discovery platforms to discover, develop and deliver novel treatments for patients.

Building upon our transformative work and legacy in hematology and Immuno-Oncology that has changed survival expectations for many cancers, our researchers are advancing a deep and diverse pipeline across multiple modalities. In the field of immune cell therapy, this includes registrational CAR T cell agents for numerous diseases, and a growing early-stage pipeline that expands cell and gene therapy targets, and technologies. We are developing cancer treatments directed at key biological pathways using our protein homeostasis platform, a research capability that has been the basis of our approved therapies for multiple myeloma and several promising compounds in early- to mid-stage development. Our scientists are targeting different immune system pathways to address interactions between tumors, the microenvironment and the immune system to further expand upon the progress we have made and help more patients respond to treatment. Combining these approaches is key to delivering potential new options for the treatment of cancer and addressing the growing issue of resistance to immunotherapy. We source innovation internally, and in collaboration with academia, government, advocacy groups and biotechnology companies, to help make the promise of transformational medicines a reality for patients.

About Opdivo

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the bodys own immune system to help restore anti-tumor immune response. By harnessing the bodys own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

Opdivos leading global development program is based on Bristol Myers Squibbs scientific expertise in the field of Immuno-Oncology, and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.

In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China. In October 2015, the Companys Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union.

INDICATIONS

OPDIVO (nivolumab), as a single agent, is indicated for the treatment of patients with unresectable or metastatic melanoma.

OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic melanoma.

OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

OPDIVO (nivolumab), in combination with YERVOY (ipilimumab) and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

OPDIVO (nivolumab) is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.

OPDIVO (nivolumab) is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with progression after platinum-based chemotherapy and at least one other line of therapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO (nivolumab) is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.

OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the treatment of patients with intermediate or poor risk, previously untreated advanced renal cell carcinoma (RCC).

OPDIVO (nivolumab) is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO (nivolumab) is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.

OPDIVO (nivolumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO (nivolumab) is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

OPDIVO (nivolumab) is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.

OPDIVO (nivolumab) is indicated for the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.

CheckMate Trials and Patient Populations

Checkmate 037previously treated metastatic melanoma; Checkmate 066previously untreated metastatic melanoma; Checkmate 067previously untreated metastatic melanoma, as a single agent or in combination with YERVOY; Checkmate 227previously untreated metastatic non-small cell lung cancer, in combination with YERVOY; Checkmate 9LApreviously untreated recurrent or metastatic non-small cell lung cancer in combination with YERVOY and 2 cycles of platinum-doublet chemotherapy by histology; Checkmate 017second-line treatment of metastatic squamous non-small cell lung cancer; Checkmate 057second-line treatment of metastatic non-squamous non-small cell lung cancer; Checkmate 032small cell lung cancer; Checkmate 025previously treated renal cell carcinoma; Checkmate 214previously untreated renal cell carcinoma, in combination with YERVOY; Checkmate 205/039classical Hodgkin lymphoma; Checkmate 141recurrent or metastatic squamous cell carcinoma of the head and neck; Checkmate 275urothelial carcinoma; Checkmate 142MSI-H or dMMR metastatic colorectal cancer, as a single agent or in combination with YERVOY; Checkmate 040hepatocellular carcinoma, as a single agent or in combination with YERVOY; Checkmate 238adjuvant treatment of melanoma; Attraction-3esophageal squamous cell carcinoma

About the Bristol Myers Squibb and Ono Pharmaceutical Collaboration

In 2011, through a collaboration agreement with Ono Pharmaceutical Co., Bristol Myers Squibb expanded its territorial rights to develop and commercialize Opdivo globally, except in Japan, South Korea and Taiwan, where Ono had retained all rights to the compound at the time. On July 23, 2014, Ono and Bristol Myers Squibb further expanded the companies strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies as single agents and combination regimens for patients with cancer in Japan, South Korea and Taiwan.

About Bristol Myers Squibb

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.

Celgene and Juno Therapeutics are wholly owned subsidiaries of Bristol-Myers Squibb Company. In certain countries outside the U.S., due to local laws, Celgene and Juno Therapeutics are referred to as, Celgene, a Bristol Myers Squibb company and Juno Therapeutics, a Bristol Myers Squibb company.

SOURCE: Bristol-Myers Squibb

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Opdivo (nivolumab) Demonstrated Superior Disease-Free Survival in Patients with Resected Esophageal or Gastroesophageal Junction Cancer Compared to...

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Garner Insights has added a new report titled, Global Gene Therapy Market Professional Report 2026 to its vast repository of research reports. This is a thorough report focused on the current and future prospects of the Global Gene Therapy Market. The report offers data of previous years along with an in-depth analysis from 2020 to 2026 on the basis of revenue (USD Billion). Besides, the report offers a comprehensive analysis about the factors driving and restraining the growth of the market coupled with the impact they have on the demand over the forecast period.

The market is segmented into different sections such as: by product type, by technology type, by application, by end-users, by deployment mode, and by key geography. The report then employs market breakdown and data triangulation procedures to complete the overall market engineering process and arrive at the exact statistics for all segments and sub-segments. The report on the Global Gene Therapy Markethas been curated by analyzing the top players functioning in the market. In order to get an in-depth analysis of the market, the report carried out SWOT analysis, Porters five forces analysis, and Pestel analysis.

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The report is segmented as follows:

Top Key Players: Sangamo, Spark Therapeutics, Dimension Therapeutics, Avalanche Bio, Celladon, Vical, Advantagene

By Product Type:Ex vivo, In vivo

By Application:Cancer Diseases, Monogenic Diseases, Infectious Diseases, Cardiovascular Diseases, Others

By Regions:

This report forecasts revenue growth at the global, regional, and local levels and provides an analysis of the most recent industry trends from 2020 to 2026 in each of the segments and sub-segments.In addition, the report highlights the impact of COVID-19 on the Global Gene Therapy Market. Some of the major geographies included in the market are given below:

North America (U.S., Canada)Europe (U.K., Germany, France, Italy)Asia Pacific (China, India, Japan, Singapore, Malaysia)Latin America (Brazil, Mexico)Middle East & Africa

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Key Questions Answered in the Report:

What is the current scenario of the Global Gene Therapy Market? How is the market going to prosper throughout the next 6 years?What are the emerging technologies that are going to profit the market?What is the historical and the current size of the Global Gene Therapy Market?Which segments are the fastest growing and the largest in the market? What is their market potential?What are the driving factors contributing to the market growth during the short, medium, and long term?What are the lucrative opportunities for the key players in the market?Which are the key geographies from the investment perspective?What are the major strategies adopted by the leading players to expand their market shares?Who are the distributors, traders and dealers of Global Gene Therapy market?What are sales, revenue, and price analysis by types and applications of market?

Full Description @ (https://garnerinsights.com/Gene-Therapy-Market-Research-Global-StatusForecast-by-Geography-TypeApplication-2016-2026#description)

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Impact of Covid-19 on Gene Therapy Market Trends by Countries, Type and Application | Sangamo, Spark Therapeutics, Dimension Therapeutics, Avalanche...

Recommendation and review posted by Bethany Smith

New York, Sept. 22, 2020 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Autologous Stem Cell and Non-Stem Cell Based Therapies Market - Growth, Trends, and Forecast (2020 - 2025)" - https://www.reportlinker.com/p05974135/?utm_source=GNW

- Stem cell technology is found to be a speedily developing technology which plays a major role in regenerative medicine, as it also serves the disciplines of tissue engineering, developmental cell biology, cellular therapeutics, gene therapy, chemical biology, and nanotechnology. Stem cells offer the possibility of replacing the cells and tissues to treat various conditions including spinal cord injury, arthritis, and Parkinsons disease, among others.- The applications of stem cell technologies in the treatment of diseases have ultimately increased the overall adoption rate of these technologies across the world.- The advantage of autologous stem cell transplant is that one is getting ones own cells back. This means there is no risk that the immune system of the individual will reject the transplant or that the transplanted cells will attack or reject the individuals body.

Key Market TrendsCancer Holds Significant Share in the Autologous Stem Cell and Non-Stem Cell Based Therapies Market

- Cancer rates could further increase by 50%, to 15 million new cases by 2020, as per World Cancer Report. It also provides clear evidence that healthy lifestyles and public health action by governments and health practitioners could stem this trend, and prevent as many as one-third of cancers, worldwide.- The American Cancer Society, the leading body in cancer stats and figures, reports 1,685,210 estimated new cancer cases and 595,690 deaths due to cancer in 2016, in the United States.- The National Cancer Institute reports that more than 60% of the worlds new cancer cases occur in Africa, Asia, and Central and South America; 70% of the worlds cancer deaths also occur in these regions. The International Agency for Research on Cancer (IARC) predicts that by 2030, the global burden is expected to rise to 21.7 million new cancer cases and 13 million cancer deaths, simply due to growth and aging of population, leaving aside factors, such as smoking, poor diet, physical inactivity, and fewer childbirths in economically developing countries.- According to WHO, almost 70% of deaths from cancer occur in low and middle-income countries, and only one in five low- and middle-income countries has the necessary data to drive cancer policy. This global and extensive threat of cancer remains a major market driver for new cancer therapies that help in risk assessment, early diagnosis, and effective monitoring of the treatment.

North America Dominates the Autologous Stem Cell and Non-Stem Cell Based Therapies Market

- North America dominated the overall stem cell market with the United States contributing to the largest share in the market.- The ease in the US government regulations and availability of funds from various organizations, like the National Institute of Health, have provided the potential for researchers to invest more in the use of biomarkers in drug discovery, drug development, detection of specific tumors, monitoring biological response to cancer therapy, and genetic studies for the identification of predisposed candidates of cancer.- In 2014, the Sanford Stem Cell Clinical Center at the University of California, San Diego (UCSD) Health System, announced the launch of a clinical trial, in order to assess the safety of neural stem cellbased therapy in patients with chronic spinal cord injury.- Researchers hoped that the transplanted stem cells may develop into new neurons that could replace severed or lost nerve connections, and restore at least some motor and sensory functions. Such numerous stem cell studies across the United States have helped in the growth of the stem cell market.

Competitive LandscapeThe global Autologous Stem Cell and Non-Stem Cell-Based Therapies market is competitive and consists of a few major players. The companies includes Novartis AG, BrainStorm Cell Limited, Caladrius, Cytori Therapeutics Inc., Dendreon Pharmaceuticals LLC, Gilead Sciences Inc., Regeneus Ltd, U.S. Stem Cell, Inc, among others, hold the substantial market share in the growth of overall market.

Reasons to Purchase this report:- The market estimate (ME) sheet in Excel format- 3 months of analyst supportRead the full report: https://www.reportlinker.com/p05974135/?utm_source=GNW

About ReportlinkerReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place.

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Autologous Stem Cell and Non-Stem Cell Based Therapies Market - Growth, Trends, and Forecast (2020 - 2025) - GlobeNewswire

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ALPHARETTA,Ga., Sept. 21, 2020 /PRNewswire/ --Robert E. Windsor, MD, is being recognized by Continental Who's Who as a Distinguished Leader for his remarkable contributions in the field of Medicine and for his dedication and commitment as the President, Medical Director, and Regenerative Medicine Specialist at Georgia RegenRX.

Located in the greater Atlanta area at 5755 North Point Pkwy, Suite #72, Alpharetta, Georgia, Georgia RegenRX offers expert, caring pain management and regenerative medical services to the Atlanta metropolitan area. Dr. Windsor plans to expand his practice into all aspects of regenerative medicine to include aesthetics and life extension. He believes that people do not need to age physiologically nearly as rapidly as they traditionally have and that they should remain mentally and physically vital and continue to look good while they age. An acclaimed physician, he has helped thousands of patients recover from the pain and improve their quality of life.

Backed by more than three decades of experience, Dr. Windsor is a top physician in Fulton County and will be expanding his practice into Forsyth and Gwinnett counties in 2021. His areas of expertise include interventional pain medicine, interventional orthopedics, regenerative medicine (e.g., stem cell therapy), integrative medicine, longevity medicine, and pain management for arthritis, chronic spinal pain, and sports injuries. In addition to his administrative and clinical experience, he has held numerous faculty positions. He has been a Pain Management Fellowship Director at Emory University, a leader at the American Academy of Physical Medicine, and a Visiting Professor at the University of Pennsylvania and Temple University among others.

Pursuing a pain/rehabilitative/physical medicine career to help others, Dr. Windsor always keeps, "the patient first and foremost." He has been highly successful because he continues to learn and develops new and improved skill sets. He advises new doctors to, "Stay up to date on emerging technologies in the biological field (i.e.: Stem cells)". He loves his field, remaining in his career for so many years because of his fervor for improving the function and quality of life of injured, ill, and/or elderly people.

In preparation for his career, Dr. Windsor earned a medical degree from the Texas A&M University College of Medicine at the age of twenty-three. He went on to complete a competitive residency program in physical medicine and rehabilitation at the University of Texas Health Sciences Center at San Antonio. Then, he earned board certification in Physical Medicine, Electrodiagnostic Medicine, Pain Medicine, Pain Management, Age Management Medicine, and Regenerative Medicine and he is currently completing a fellowship in Aesthetic Medicine.

A frontrunner in his field, Dr. Windsor has been board certified by the American Board of Physical Medicine, American Board of Pain Medicine, American Board of Pain Management, American Board of Electrodiagnostic Medicine, American Board of Age Management Medicine, and the American Board of Regenerative Medicine. In appreciation of his service, Dr. Windsor was honored as America's Top Physician by the Consumers Research Council of America in 2014. The President of PASSOR, he has received the following PASSOR awards: Distinguished Clinician, Distinguished Committee, and Distinguished Member. He has been active in his field throughout his career, having previously served as the past-Executive Board Member of the AAPM&R.

A lifelong athlete, Dr. Windsor enjoys staying active. He likes lifting weights, snow skiing, scuba diving, boating, and skydiving. He is heavily involved with his family. He has many offspring, several of whom are engaged in the medical field.

Dr. Windsor dedicates this recognition to Stanley Herring, MD, Richard Derby, MD, Charles April, MD, and Daniel Dumitru, MD, Ph.D. For more information, please visit https://www.garegenrx.com

Contact: Katherine Green, 516-825-5634[emailprotected]

SOURCE Continental Who's Who

Georgia RegenRX, LLC

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Robert E. Windsor, MD, is being recognized by Continental Who's Who - PRNewswire

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Owners of the popular Prince pub in West Brompton are hoping for permission to stay open for three more years.

The Earls Court Partnership Ltd has applied to Hammersmith and Fulham Council for planning permission to keep using the property, including its huge covered beer garden, for another three years.

The company first opened the pub in 2017 after consent was given to use land that was previously the back gardens of three homes in Empress Place.

It also owns the sprawling Earls Court development site to the north of the pub, as well as the Victorian terraces in Empress Place, and pop up shops in Lillie Road.

The company is the joint venture between TfL, Delancey and Dutch pension firm APG.

Its planning application said: The proposal will provide amenity and improvement to the street frontage, as well as bring new life to the area well in advance of the wider redevelopment.

The Earls Court Partnership is thought to be working on new plans to build homes across the vast, empty site where the Earls Court Exhibition Centre once stood.

Delancey and APG purchased their shares in the ECP from Capital and Counties last year for 425 million.

Capital and Counties originally bought the land, which previously included the West Ken and Gibbs Green estates, from Hammersmith and Fulham Council in 2012 for 105 million.

Members of the Fulham and Hammersmith Historical Society have previously been critical of the ECP for failing to put 11 other vacant houses in Empress Place to use for people who need social housing. They, and several other flats in Lillie Road have long stood empty.

The councils website indicates that ECPs planning application will be decided in October.

If you have a story from Hammersmith and Fulham, please email our reporter: owen.sheppard@reachplc.com

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Owners of The Prince pub in West Brompton seek three-year life extension - My London

Recommendation and review posted by Bethany Smith

The space industry has a rich history of building supply-chain relationships to deliver complex and exacting space systems. The industry is also no stranger to partnering closely with suppliers and customers, including governments, to develop and deliver new technology and advance the art of the possible.

However, while public-private partnerships are getting a lot of attention, the space industry has not traditionally leveraged non-supply chain partnerships as frequently or as fluidly as some industries. This is particularly true when it comes to go to market and ecosystem collaboration between two space companies or between a space company and a non-space company. These are partnerships where neither company is primarily a supplier or customer to the other. In this model partners collaborate to reach new customers or to deliver integrated solutions or both, often preserving choice for customers in the process.

Companies like SpaceX and Blue Origin have the financial resources to vertically integrate, go to market independently, and extend product and service capabilities largely with in-house resources. However, most venture-backed or smaller space companies need to rely on external partners as a core part of their marketing, sales, product, and customer service strategies. Established space companies are increasingly choosing to partner with companies outside their supply chain as well. With the advent of the entrepreneurial space age, the industry is forming more partnerships, innovating on business model design, and developing best practices for successful collaborations. This is a sign of a maturing industry.

Rocket Labs partnership with KSAT is a good example. Announced at the International Astronautical Congress in Washington in October 2019, this collaboration offers a complete solution for customers who need both a ride to space and communications services for their payload. Rocket Labs Photon kick stage hosts the customers payload, and KSAT offers the communications services. The full-service offering can be purchased directly from Rocket Lab. This lets customers focus on their payload and mission, rather than integrating and managing vendor products and services.

Rocket Labs business development administrator, Lisa Stojanovski, says its all about providing options for customers. Customers can use any ground segment provider, but if they dont have one lined up and want to take advantage of Photon, we provide the communications services leveraging KSAT.

Customers eyes light up, she says, when they realize we can do it all for them in one stop.

SES, a leader in global content connectivity solutions with more than 70 satellites in geostationary and medium Earth orbit, offers another example of joint solution partnering. SES collaborates with several leading cloud providers. As the business world shifts increasingly to cloud computing, many companies have critical remote operations that remain disconnected from the cloud. SES solves this problem by offering dedicated, private network connectivity via satellite communications bundled with cloud services from cloud providers like Microsoft Azure.

Sergy Mummert, SESs senior vice president of cloud and strategic partnerships, says this reduces risk for customers and lowers sales barriers. Together with our partners, we are building out a suite of targeted services for each market segment, Mummert says. The value proposition of the partnership couldnt be clearer. SES drives more network traffic. The cloud provider delivers more services. Customers get a vetted solution that provides more capability at lower cost.

Some entrepreneurial space companies that initially started with an in-house approach are migrating to a business model which incorporates partnerships as a core strategy. Planet, one of the industry leaders in Earth observation and remote sensing, is a case in point.

The Earth observation segment has a dual go-to-market challenge. First, complex images and raw data need to be transformed into usable insights or decisions that business users can easily consume. Second, these decision solutions need to be marketed and sold in unique ways to very different segments and buyers in distinct vertical industries. After initially trying to go it alone, Planet created a partner program to address these obstacles.

Planets partner program connects customers to experts who can deliver specific vertical solutions across industries as diverse as energy, forestry, agriculture, and government, among others. This is a classic example of a go-to-market partnership model. It enables Planet to scale faster by reaching more qualified customers across a broader set of market segments with value-added solutions.

Daniel Faber, the CEO of Orbit Fab, highlights another type of strategic relationship. He believes market development partnerships can be hugely valuable in nascent markets or when a shift in business practices is required. Orbit Fab provides gas stations in space, propellant tankers that refuel satellites for revenue-generating life extension and other novel use cases. With a keen understanding of the entire satellite value chain, Orbit Fab is planning a joint demonstration mission with a satellite servicing company. While proving out the technology is one goal for the partnership, Faber says the primary objective is to provide confidence to satellite operators and allow satellite servicers to build refueling into their business models.

Partnerships certainly arent easy, and they arent without risks. Justifiable concerns include loss of control, protecting intellectual property, and management overhead. However, with the right process and agreements, these factors can usually be mitigated. Ron Faith, the chief operating officer at ground station as a service company RBC Signals, says, Partnerships come with a lot of complexity and dimensions and need to be well crafted. Otherwise, some partnerships can fail to produce.

Yet, RBC Signals has made partnering a core part of its strategy. Faith says partnerships can be critical in driving standards, which reduces unnecessary friction in the market. He also sees value in leveraging partnerships to signal the market. Most important, Faith says, partnerships can help smaller space companies punch above their weight and scale faster, for instance by collaborating with larger prime contractors.

In an industry as diverse as space, the opportunities and objectives for partnerships vary considerably by market segment and by company. For instance, the business drivers that dictate partnership strategies are typically quite different for infrastructure companies than for application companies. Even within a segment, different strategies and values drive unique approaches to partnering. There is no one-size fits all model.

Yet, according to an increasing number of space leaders and entrepreneurs, every space company needs to think holistically about its make-buy-partner strategy what activities to keep in house, what products and services to procure from suppliers, and how to partner to provide improved market access and more competitive offerings.

Some companies stumble into a partner strategy by trial and error. Getting it right, though, usually requires developing a deep understanding of ones ecosystem and value chain. It also requires thinking through each core function research and development, marketing, sales, production, delivery, and support to evaluate where partnerships can add value. This thought process leads to a practical and dynamic partner strategy including partnerships that may come and go over time as a company changes and grows.

In an industry as difficult and complex as space, very few companies can go it alone. Partnerships are a strategic weapon space companies can deploy to build awareness, reach more customers faster, and deliver more complete and valuable solutions. To grow the space ecosystem, and ultimately develop a true in-space economy, the industry needs to incorporate partnerships into its business models. Partnerships are the oxidizer for the space economy, and the companies who excel at partnering will rocket ahead of the pack.

Stan Shull is a space and software industry consultant at Alliance Velocity, LLC, where he specializes in partnerships, competitive strategy, and exit planning. Follow him on Twitter @stanshull.

This article originally appeared in the Sept. 14, 2020 issue of SpaceNews magazine.

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Op-ed | Building a robust space economy requires more partnerships - SpaceNews

Recommendation and review posted by Bethany Smith

The Global Glucose Tolerance Test Market is segmented on the lines of its technology, treatment, application and regional. Based on technology segmentation it covers Based on product analysis it is segmented into Blood glucose testing kit, Smart sensors and other. Further blood glucose testing kit is again segmented as Lancet, Meters, Test strips and others. On the basis of the indication analysis segmentation it includes Diabetes, Gestational diabetes, Insulin resistance, Reactive hypoglycemia. On the basis of the end user analysis it is segmented as Diagnostic Clinics, Hospitals, Home and others. The Global Glucose Tolerance Test Market on geographic segmentation covers various regions such as North America, Europe, Asia Pacific, Latin America, Middle East and Africa. Each geographic market is further segmented to provide market revenue for select countries such as the U.S., Canada, U.K. Germany, China, Japan, India, Brazil, and GCC countries.

You Can Browse Full Report: https://www.marketresearchengine.com/glucose-tolerance-test-market

The report covers detailed competitive outlook including the market share and company profiles of the key participants operating in the global market. Key players profiled in the report include Johnson & Johnson (U.S.), Dexcom, Inc. (U.S.), Merck (U.S.), Quest Diagnostics (U.S), BAYER (Germany), Abbott (U.S.), ARUP Laboratories (U.S.), E-Zlab Health Services (U.S.),, Life Extension (U.S.), Laboratory Corporation of America Holdings (U.S.), Cleveland Heart Lab, Inc (U.K), Penlan Healthcare Ltd, PAML (U.S.), Dorevitch Pathology (Australia), Nipro Diagnostics, Inc. (Japan), Medtronic (U.K), and Thermo Fischer Scientific (U.S.). Company profile includes assign such as company summary, financial summary, business strategy and planning, SWOT analysis and current developments.

The scope of the report includes a detailed study of global and regional markets on Glucose Tolerance Test Market with the reasons given for variations in the growth of the industry in certain regions.

A glucose tolerance test measures how well a bodys cells is able to engage glucose, or sugar, after a patient intakes a given measure of sugar. Specialists and doctors utilize fasting glucose levels and hemoglobin A1C esteems to distinguish compose 1 and sort 2 diabetes, and pre-diabetes though a glucose resistance test can likewise be utilized. Specialists fundamentally utilize a glucose resilience test to analyze gestational diabetes in patients. Authorities and specialists regularly analyze type 1diabetes quickly on the grounds that it every now and again grows rapidly and incorporates high glucose levels. Sort 2 diabetes, then again consistently creates over years. Sort 2 diabetes is the most widely recognized type of diabetes, and it by and large creates amid adulthood. Gestational diabetes emerges when a pregnant lady who doesnt have diabetes before pregnancy, along these lines has high glucose levels because of the pregnancy.

The Global Glucose Tolerance Test Market has been segmented as below:

The Global Glucose Tolerance Test Market is Segmented on the lines of End user Analysis, Product Analysis, Indication Analysis and Regional Analysis. By End user Analysis this market is segmented on the basis of Diagnostic Clinics sector, Hospitals sector, Home sector and Others sector. By Product Analysis this market is segmented on the basis of Blood glucose testing kit, Lancet, Meters, Test strips, Others, Smart sensors and Other.

By Indication Analysis this market is segmented on the basis of Diabetes, Gestational diabetes, Insulin resistance and Reactive hypoglycemia. By Regional Analysis this market is segmented on the basis of North America, Europe, Asia-Pacific and Rest of the World.

This report provides:

1) An overview of the global market for Glucose Tolerance Test Market and related technologies.2) Analyses of global market trends, with data from 2015, estimates for 2016 and 2017, and projections of compound annual growth rates (CAGRs) through 2024.3) Identifications of new market opportunities and targeted promotional plans for Global Glucose Tolerance Test Market.4) Discussion of research and development, and the demand for new products and new applications.5) Comprehensive company profiles of major players in the industry.

The Global Glucose Tolerance Test Market is expected to exceed more than US$ 24000.0 Million by 2024 at a CAGR of 10.5% in the given forecast period.

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1) Obtain the most up to date information available on all Global Glucose Tolerance Test Market.2) Identify growth segments and opportunities in the industry.3) Facilitate decision making on the basis of strong historic and forecast of Global Glucose Tolerance Test Market data4) Assess your competitors refining portfolio and its evolution.

The major driving factors of Global Glucose Tolerance Test Market are as follows:

The restraining factors of Global Glucose Tolerance Test Market are as follows:

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Glucose Tolerance Test Market Extensive Growth Opportunities to Be Witnessed by 2019-2027 - The Daily Chronicle

Recommendation and review posted by Bethany Smith

New research report on FPSO market, which is a detailed analysis of this business space inclusive of the trends, competitive landscape, and the market size. Encompassing one or more parameters among product analysis, application potential, and the regional growth landscape, FPSO market also includes an in-depth study of the industry's competitive scenario.

Rising focus toward discovery and development of smaller reserves located at remote offshore locations will strengthen the FPSO market growth. In January 2018, Chevron Corporation proclaimed the discovery of an ultra-deep sea oil reserve at a water depth of almost 1,900 meters, offshore in the U.S. Gulf of Mexico. Additionally, the redeployment potential of these units to a different production site upon exhaustion of one, along with their ability to withstand severe weather conditions will escalate the product demand.

The converted FPSO market in 2018, witnessed an annual deployment of 7 units. High potential to redeploy & refurbish numerous retired VLCC and ULCC vessels will positively influence the deployment of these units. Moreover, key industry players being driven by international maritime regulations are invariably seeking redeployment and conversion for such assets to FPSO vessels. Relatively much lower capex along with shorter development schedule associated with these units is yet another factor encouraging the deployment of these vessels.

Request Sample Copy of this Report @ https://www.theresearchprocess.com/request-sample/6962

FPSO Market is predicted to reach over USD 30 Billion by 2025. Ongoing offshore exploration & production activities driven by diminishing onshore oil & gas reserves will drive the FPSO market growth. Development challenges associated with fixed infrastructures including site accessibility, excessive costs, environmental conditions and decommissioning issues will further favor the deployment of FPSOs as a viable alternative. Moreover, growing inclination toward fast-track floating solutions along with advancement in subsea technologies will continue to accelerate the industry growth.

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Shifting trends toward development and production from ultra-deep offshore reserves favored by evolving drilling and seismic technologies along with wide presence of proven deep-water reserves will positively influence the ultra-deep FPSO market. According to the EIA, oil production from ultra-deep waters has increased by 25 percent in a decade, increasing from 7 million bpd extracted in 2005 to 9.3 million bpd in 2015.

Latin America FPSO market will witness robust growth owing to the positive outlook of state owned companies favored by supportive government initiatives along with recent discovery of substantial pre salt oil reserves. According to Petrobras, Campos and Santos basins located offshore in Brazil have an estimated 6 billion barrels reserve of pre salt oil. Additionally, Brazil?s recent local content regulation implying easier and lower requirements with reduction in fines for E&P contracts will escalate the vessel deployment across the country.

New built FPSO market will witness strong growth on account of growing investments toward development of deep and ultra-deep-water reserves. Optimum design parameters, flexible to field life extension and lower operational cost along with advanced safety features are analyzed to be the key features that will accelerate the product penetration. Advancements in offshore technologies, including double hull & cylindrical hull designs and separable turret system will further attract investments across the industry. However, much higher capex and longer project schedules as compared to its converted alternative may restrain the deployment of these vessels.

Key industry players operating in the FPSO market include SBM Offshore, Technip, KBR, Saipem, Samsung Heavy Industries, DSME, Hyundai Heavy Industries, Petrobras, MODEC, Woodside Petroleum, CNOOC, Bumi Armada and BW Offshore amongst others.

Major Highlights from Table of contents are listed below for quick lookup into FPSO Market report

Chapter 1. Methodology and Scope

Chapter 2. Executive Summary

Chapter 3. FPSO Industry Insights

Chapter 4. Company Profiles

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FPSO Market Detailed Analysis of Current Industry Figures with Forecasts Growth By 2025 - The Research Process

Recommendation and review posted by Bethany Smith

By Owen Sheppard, Local Democracy Reporter

Owners of a popular West Brompton pub are hoping to receive a three-year life extension.

The Earls Court Partnership Ltd (ECP) has applied to Hammersmith and Fulham council for planning permission to keep using the Prince pub, in Lillie Road, including its huge covered beer garden, for another three years.

The company first opened the pub in 2017 after consent was given to use land that was previously the back gardens of three homes in Empress Place.

It also owns the sprawling Earls Court development site to the north of the pub, as well as the Victorian terraces in Empress Place, and pop up shops in Lillie Road.

The company is a joint venture between Transport for London (TfL), Delancey and Dutch pension firm APG.

Its planning application said: The proposal will provide amenity and improvement to the street frontage, as well as bring new life to the area well in advance of the wider redevelopment.

The councils website indicates that ECPs planning application will be decided in October.

Pictured top: The Prince in Lillie Road, West Brompton

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So if you have enjoyed reading this story, and if you can afford to do so, we would be so grateful if you can buy our newspaper or make a donation, which will allow us to continue to bring stories like this one to you both in print and online.

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Prince pub in West Brompton applies to stay open for three more years - London News Online

Recommendation and review posted by Bethany Smith

Sciences most powerful ingredients are better together.

Every skin-care enthusiast has heard of retinol, the dermatological gold standard in anti-aging and vitamin A derivative that lessens the appearance of fine lines and wrinkles, promotes collagen production, minimizes breakouts, and resurfaces your skin. But the famed ingredient is also known for some of its less desirable side effectsnamely, irritation, redness, flaking, and photosensitivity, which can make it intolerable for sensitive skin types and unsafe for use in pregnant and nursing women.

Even as most dermatologists laud retinol for its extensive benefits, holistic aestheticians remain wary of the actives corrosive effects on the skin barrier. Because the skin barrier is key for retaining moisture and protecting the dermis from external irritants, aggressors, pollutants, and more, compromising it can sensitize skin, making it more susceptible to inflammation and irritation.

Growth factors have piqued our interest for being a sensitive-skin-friendly alternative to retinol, as these pro-healing proteins are safe for more continued use and are non-corrosive to the stratum corneumthe outermost layer of the epidermisand are gentle enough for sensitive skin types. But if youre not quite ready to let go of your retinol, it turns out that they can be used together to enhance the potency of your anti-aging regimen, even buffering the skin from some of retinols less desirable side effects.

Keep reading to get schooled on the use of growth factors in skin care according to dermatologists, and some guidance on whether the controversial ingredient could be right for you to try next.

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As we grow older, our skins natural production of collagen decreases (starting around age 25), the elastin fibers begin to stiffen, and our skin produces lower quantities of growth factors, resulting in various signs of aging, like fine lines, crepiness, thinness, and sagging. This is where adding a topical growth factor into your routine can help. Says Lily Talakoub, MD, dermatologist and owner of dermtodoor.com, A growth factor is a large protein derived from human cells that targets the crucial turnover of cells, [promoting the increase] of [structural proteins] such as collagen and elastin.

Although they were first discovered in the 1950sand the scientists who did it were awarded the Nobel Prize for their research in 1986there was still some confusion as to how growth factors worked and their efficacy. But in the last few years, there has been a flurry of new anti-aging products that use growth factors like EGF (epidermal growth factor).

As Dr. Talakoub explains, growth factors stimulate the regeneration of cells that fight various signs of aging by prompting the cells to produce the structural components of the skin that are responsible for elasticity, firmness, and bounce. Specifically, ultra-healing EGF binds to the EGF receptor in the cell, aiding with cell proliferation, survival, and promoting DNA synthesis. By fortifying the presence of the structural tissues in the skin matrix, research shows that we can expect fewer fine lines and wrinkles over time. Think of growth factors as the key that unlocks and activates the cell to produce collagen and elastinboth of which give us that youthful lookand also help promote cell turnover and fight against inflammation.

As board-certified dermatologist Dr. Hadley King points out, growth factors like EGF can also be used to increase skin thickness and to improve tone and texture, particularly for sensitive skin types. If your skin is too sensitive to tolerate retinoids, then growth factors can be a substitute to stimulate collagen, even tone, and decrease roughness with much less irritation.

Dr. King explains that these proteins are almost universally tolerable, likely due to their natural presence in the body, and through inducing the bodys own natural mechanisms for repair, which in turn promotes skin healing. When they bind to receptors on cell surfaces, King continues, they send commands to repair, rejuvenate, and replicate. This makes them an excellent option for skin concerns ranging from inflammation and acne to fading scarring and post-inflammatory hyperpigmentation.

Thanks to the Kardashians, youve undoubtedly heard of the trendy vampire facial, which uses your bodys own PRPplatelet-rich plasma that is derived from your own bloodto treat acne scars and smooth skin texture. This makes them a fantastic addition to your post-laser or post-microneedling treatment at the dermatologist. Adding a growth factor serum like PRP can also enhance the efficacy of the treatment, as well as reduce healing time.

While a PRP serum created in a centrifuge from your own blood is the ultimate way to go for an in-office encounter with growth factors, you can also follow up at home with a growth-factor-based serum to maximize your treatments effects. Just be sure to perform a patch test before applying it to the area that was treated, as that skin might still be extra sensitive and prone to inflammation.

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One of the most important things to consider when selecting a growth factor comes down to the source. When we think of epidermal growth factor (EGF), there are two common methods of sourcing: bio (i.e., human- or animal-derived) and phyto (i.e., plant-derived). The general consensus within the scientific community seems to be that human-derived growth factors, especially PRP, are the most effective. Says Dr. Talakoub, Plant-based growth factors do not stimulate the growth of in vivo cells [in] the same [way] as ones derived from human cells.

However, not everyone is comfortable using a biological source for their skin-care products, even if they might deliver superior results. In products like the wildly popular growth-factor-based serums from SkinMedica and NeoCutis, the initial cell samples were obtained from neonatal fetal foreskin and fetal fibroblast cells, respectively, before being grown in the lab for use in their products. Depending on your ethical and political views, this might be an issue to consider before you try using these types of formulas.

And while these holy grail serums do use human stem cells, keep in mind that there are no body partswe repeat, absolutely no penises!in these serums, despite what Cate Blanchett says.

If youd rather bypass the ethical controversy of a human- or animal-derived growth factor altogether, rest assured that there are plant-based options. There are some engineered options that have been well tested and shown to be effective, says Dr. King, noting that the brands BIOEFFECT and DNA Renewal have both exhibited promising results related to skin repair, rejuvenation, and enhancement via a humanlike epidermal growth factor made in bio-engineered barley seeds.

Dr. Bjrn rvar, co-founder and chief scientific officer of BIOEFFECT, the makers of the worlds first bio-engineered, plant-based EGF, strongly believes that phyto-EGF is the new frontier in terms of tolerability, efficacy, and even safety. EGF has previously been grown in bacteria, which poses a risk of endotoxins, or extracted from human or animal cells, which presents ethical, moral, and legal issues as well as safety issues.

There are also upsides to selecting a phyto-sourced, synthetic EGF that go beyond ethics and speak to precision and measurable outcomes. The advantage to plant-derived growth factors is that there is a more defined concentration of known synthetic growth factors, and so it is theoretically easier to measure and predict outcomes, says dermatologist Dr. Mamina Turegano. And now with studies pointing to phyto sources of growth factor improving epidermal thicknesswhich thins as we agethese phyto-sourced options could be the new frontier in terms of bypassing the controversy altogether.

Because these two anti-aging actives work differently, with retinol promoting the turnover of keratinocytes (the primary type of cell in your epidermis) and growth factors targeting the formation of cells that produce collagen and elastin and strengthening your skin barrier, EGF and retinol can be used together to maximize your anti-aging skin-care routine.

So what happens when you use a growth factor along with a retinol product? Most growth factors are extremely large proteins [which] have a very difficult time penetrating the outer lipid bilayer of the skin, says Talakoub. Using a retinoid in combination with a growth factor allows [it] to penetrate the outer layers of the skin. She suggests using a vitamin C product during the daytime, and then layering your EGF with your retinol at night to see the best results.

If you do choose to use an EGF serum in conjunction with your favorite retinol, rvar recommends a particular process. We recommend always applying the EGF serum first, on clean skin, and allowing 510 minutes before applying anything else on top [to] give it time to activate the skin cells and do its magic, he notes. As he explains, EGF will help to boost hydration and counter the thinning of the skins outer layer that can occur with retinol. Their synergistic effects are the perfect complement to each other and will help make your anti-aging skin-care routine even more effective.

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The Anti-aging Benefits of Using Growth Factors Plus Retinol - Coveteur

Recommendation and review posted by Bethany Smith

The medical skin care products is primarily driven by the need of natural based active ingredients products which are now trending in the market. Consumers demand medical skin care products which favor health and environment. Moreover, the consumers are updated with the trends so that various companies end up providing such products to satisfy the customers. For instance, a single product face mask has thousands of different variants. This offers consumers different options to select the product depending on the skin type. Moreover, the market players catering to the medical skin care products are offering products with advanced technologies. For instance, Santinov launched the CICABEL mask using stem cell material based on advanced technologies. The stem cells used in the skin care product helps to to protect and activate the cells and promote the proliferation of skin epidermal cells and the anagenesis of skin fibrosis.

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The Medical Skin Care Products market to Witness an Impulse between 2017 and 2025 - Industry Today

Recommendation and review posted by Bethany Smith

If you regularly read my beauty content (thanks and Hi mum!), you'll know that I'm a huge fan of celebrity skincare fave, iS Clinical. Their formulas are revered for combining highly active ingredients and plant-derived extracts with modern science. They're all are fragrance and paraben-free and directly tackle all major skin concerns dry, dull skin, anti-ageing, pigmentation, uneven skin tone and texture.

About three or so months ago, they finally landed an Australian stockist and I was able to get my hands on their Reparative Moisture Emulsion and Pro-Heal Serum. To say I was impressed with the results was an understatement, so I decided it was time to bench my go-to cleanser and give their cult-classic Cream Cleanser a whirl.

When it comes to ingredients, iS Clinical only use high-grade, dermatologist-recommended ingredients like plant-derived acids, vitamins A to E, stem cells and ceramides, so you know that you're going to get good results. But this, this cleanser surpassed my expectations and is perfect if, like me, you're lazy and CBF washing your face too regularly. (Naughty beauty writer, I know).

The Cream Cleanser combines bio-nutrients, antioxidants, and restorative ingredients that work to thoroughly cleanse the surface and pores of the skin while soothing the look and feel of any dry patches. One of my favourite parts about this cleanser is that post-cleanse, your skin is left feeling refreshed, hydrated and clean, rather than tight and dried out. My other favourite part (and here's where my inner lazy girl fell in love) is that you don't even have to wash it off, you can simply wipe it off with a muslin cloth and voila, you're done.

I've been using this cream cleanser for about a month now and I've already noticed a difference in my skin. And I'm not alone, Chrissy Teigen, Rosie Huntington-Whiteley, January Jones and Zoey Deutch are all huge fans, too!

Scroll to shop iS Clinical's Cream Cleanser.

Original post:
I Used to Hate Washing My Face But Now I'm Reaching for This Cult-Cleanser Constantly - POPSUGAR Beauty Austrailia

Recommendation and review posted by Bethany Smith

Anti-Ageing Drugs Market Data and Acquisition Research Study with Trends and Opportunities 2019-2025The study of Anti-Ageing Drugs market is a compilation of the market of Anti-Ageing Drugs broken down into its entirety on the basis of types, application, trends and opportunities, mergers and acquisitions, drivers and restraints, and a global outreach. The detailed study also offers a board interpretation of the Anti-Ageing Drugs industry from a variety of data points that are collected through reputable and verified sources. Furthermore, the study sheds a lights on a market interpretations on a global scale which is further distributed through distribution channels, generated incomes sources and a marginalized market space where most trade occurs.

Along with a generalized market study, the report also consists of the risks that are often neglected when it comes to the Anti-Ageing Drugs industry in a comprehensive manner. The study is also divided in an analytical space where the forecast is predicted through a primary and secondary research methodologies along with an in-house model.

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The following manufacturers are covered:Nu SkinBIOTIMEElysium HealthLa Roche-PosayDermaFix

Access this report Anti-Ageing Drugs Market @ https://hongchunresearch.com/report/worldwide-anti-ageing-drugs-market-2019-61916

Segment by RegionsNorth AmericaEuropeChinaJapan

Segment by TypeHormonal TherapyAntioxidantsEnzymesStem CellsOthers

Segment by ApplicationSkinHairOthers

For a global outreach, the Anti-Ageing Drugs study also classifies the market into a global distribution where key market demographics are established based on the majority of the market share. The following markets that are often considered for establishing a global outreach are North America, Europe, Asia, and the Rest of the World. Depending on the study, the following markets are often interchanged, added, or excluded as certain markets only adhere to certain products and needs.

Here is a short glance at what the study actually encompasses:Study includes strategic developments, latest product launches, regional growth markers and mergers & acquisitionsRevenue, cost price, capacity & utilizations, import/export rates and market shareForecast predictions are generated from analytical data sources and calculated through a series of in-house processes.

However, based on requirements, this report could be customized for specific regions and countries.

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Major Point of TOC:

Chapter One: Anti-Ageing Drugs Market Overview

Chapter Two: Global Anti-Ageing Drugs Market Competition by Manufacturers

Chapter Three: Global Anti-Ageing Drugs Production Market Share by Regions

Chapter Four: Global Anti-Ageing Drugs Consumption by Regions

Chapter Five: Global Anti-Ageing Drugs Production, Revenue, Price Trend by Type

Chapter Six: Global Anti-Ageing Drugs Market Analysis by Applications

Chapter Seven: Company Profiles and Key Figures in Anti-Ageing Drugs Business

Chapter Eight: Anti-Ageing Drugs Manufacturing Cost Analysis

Chapter Nine: Marketing Channel, Distributors and Customers

Chapter Ten: Market Dynamics

Chapter Eleven: Global Anti-Ageing Drugs Market Forecast

Chapter Twelve: Research Findings and Conclusion

Chapter Thirteen: Methodology and Data Source 13.1 Methodology/Research Approach13.1.1 Research Programs/Design13.1.2 Market Size Estimation13.1.3 Market Breakdown and Data Triangulation13.2 Data Source13.2.1 Secondary Sources13.2.2 Primary Sources13.3 Author List13.4 Disclaimer

About HongChun Research:HongChun Research main aim is to assist our clients in order to give a detailed perspective on the current market trends and build long-lasting connections with our clientele. Our studies are designed to provide solid quantitative facts combined with strategic industrial insights that are acquired from proprietary sources and an in-house model.

Contact Details:Jennifer GrayManager Global Sales+ 852 8170 0792[emailprotected]

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Impact Of Covid-19 on Anti-Ageing Drugs Market 2020 Industry Challenges, Business Overview and Forecast Research Study 2026 - The Daily Chronicle

Recommendation and review posted by Bethany Smith

WADSWORTH, Ohio High-tech genetic ancestry tests retail for a couple hundred dollars.

You get to find out all this information about genetics and all of that, Tiffany Leonard said.

But the gift Leonard received after shipping off a quick swab of her saliva was priceless.

So I didn't know a lot about any genetics or medical issues that ran in our family, Leonard said. So that's really the focus of it, was to find out that stuff. I got a lot more than I bargained for.

Growing up, Leonard said she had questions about where she came from, but she was raised by a loving father and kept that skepticism tucked away for years.

I looked at the results and that was the end of it. I never looked at it again, Leonard said. My dad used to say he wasn't really sure if I was his or not because I had white hair and everybody else had brown hair.

However, she said her 23andMe results were impossible to ignore.

You'll have lots of relatives that you are like barely connected with, Leonard said. It says first cousins and second cousins. And I was like, That's weird because my dad was an only child.

Through some digging and connecting with relatives she discovered through the ancestry program, she learned the man who raised her was not her biological father.

So, of course, my whole world is reeling, Leonard said.

For more than a decade, her biological father was living just miles away.

He called me and said, Im your dad. And I was mind blown, Leonard said. And Ive worked at the hospital for 13 years and Ive passed his house for the last 13 years.

As a successful woman with three children of her own, Leonard said the last year has given her a mirror and a history she never knew existed.

I can see where my personal qualities come from, like walking into the screen door, and that part's been really fun, Leonard said. You kind of just stare at each other like, Holy mackerel. That's my dad.

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Unsuspecting Wadsworth woman finds close relatives through genetic testing - News 5 Cleveland

Recommendation and review posted by Bethany Smith

Image: Kevin and Karen Capel with their son Christopher

In 2006, Karen and Kevin Capels son, Christopher, was diagnosed with medulloblastoma a type of brain tumour accounting for 15-20 per cent of all childhood brain cancers. Two years later, Christopher passed away, nine days before his sixth birthday.

Kevin and Karens devastating loss is sadly a tragedy endured by countless families. With the aim of changing the outlook for children with cancer and opening doors to potential new treatments, Karen and Kevin Capel set up the charity Christophers Smileto help fund research into childhood cancers like medulloblastoma.

Since their charity was established, Christophers Smile has raised more than 1 million for our childhood cancer research, including funding for five of our research scientists here at The Institute of Cancer Research. Their efforts and generosity have been vital in helping identify and develop kinder, smarter treatments for children with cancer.

One of the toughest things for Karen and Kevin was to see their little boy struggle with the many side effects that go along with surgery and chemotherapy post-surgery mutism, sickness, hair loss, infections, ulcers, extreme fatigue, loss of appetite, loss of hearing.

Side effects of treatments like chemo and radiotherapy are particularly bad for children as they are still growing and their organs are more susceptible to damage. Having witnessed their sons tough treatment journey, Karen and Kevin decided that sparing children from devastating side effects was something they should prioritise in their funding efforts.

One of the teams at the ICR that they have generously supported is that of Professor Louis Chesler. Professor Cheslers Paediatric Solid Tumour Biology and Therapeutics Teamworks to understand the underlying biology of childrens cancers. The team is striving to make the biggest difference to children with cancer by developing new personalised therapies that are not only more effective but also kinder to children.

The teams research focuses on the two most common solid childhood tumours neuroblastoma, a nerve tissue cancer and medulloblastoma, the type of brain tumour that Christopher suffered from.

Image: Professor Louis Chesler in the lab

Over the last decade, Professor Cheslers team has been striving to make personalised medicine a reality for children. In this respect, one of their greatest milestones to date is his work, with colleagues at The Royal Marsden NHS Foundation Trust, to develop and implement a test that can analyse many cancer genes in childrens tumours simultaneously and rapidly.

The test has demonstrated how powerful genetic testing can be for younger patients, not just adults as it can spot specific gene alterations and help doctors pick out the best targeted drugs for children with cancer based on this genetic information.

Around 400 children at 21 leading hospitals across the UK have now started receiving the test, and NHS has incorporated it into standard practice. Commenting on the development, Karen Capel said:

Our proudest moment working with the ICR has been the introduction of a genetic sequencing panel specifically for children into NHS England test directory. The panel was developed by the ICR, funded by Christophers Smile, and the result means that children with solid tumours may now be sequenced at diagnosis and relapse across England.

The team also showed that around half of children with solid tumours meaning lumps of abnormal cells found in muscles, bones or organs, but not in the blood could benefit from targeted drugs that are already available for adults. However, their study showed that only seven per cent of kids were able to access these drugs.

Professor Cheslers work has therefore exposed the limitations and frustrating barriers that children face when it comes to receiving innovative, targeted treatments. For this reason, Kevin and Karen have been highly active in campaigning for children to have better access to cancer drugs.

The aim of Professor Cheslers team is to treat more children whose tumours have these targetable genetic defects with better drugs. The test will help them achieve their goal but, at present, they are also working on gathering the necessary data to guide the use of the most appropriate drug for each child.

It is crucial to repurpose existing targeted drugs used in adults so that children can benefit from them too but developing drugs specifically targeted at childrens cancers is also a priority for Professor Chesler and his team.

By uncovering various molecular mechanisms and interactions involved in childhood cancers and providing new ways to study the disease, the team has shed light on the drivers and mechanisms of tumour formation and progression. Thanks to this, the team is leading the way in the field of childhood cancer. Their ultimate aim is to extend the lives of children with cancer by being able to target genes that sustain the growth of childhood tumours.

Commenting on the research at the ICR made possible by Christophers Smile over the past years, Kevin Capel said:

Research is key to getting new and better treatments. When our son was diagnosed, there was no biological information available to doctors about individual childrens tumours. Our funding contributions have helped change that, as researchers at the ICR have already made discoveries that have improved our understanding of various childhood cancers.

Back in 2015, Professor Chesler discovered ways to target the unique genetic paths that medulloblastoma follows when relapse occurs and a childs disease comes back. The team showed that certain genetic changes were responsible for the cancer becoming more aggressive and identified drugs that could help to target relapse.

Since then, Professor Chesler and his team have identified new gene targets and developed animal models to better study and understand various childhood cancers, as well as to help them test new drugs before they are ready to be trialled in patients.

The hope has always been that their research will produce models and data that will form the basis of new clinical trials for children and this is already happening. For example, based on their promising findings throughout the last decade, a new drug known as fadraciclib is now ready to enter clinical trials in children with the childhood cancer neuroblastoma.

Image: Karen and Kevin Capel

While we have seen lots of progress over the last decade, survival of children with medulloblastoma, neuroblastoma and rhabdomyosarcoma especially after the disease relapses and comes back remains extremely low, and there is still a pressing need for greater understanding and new therapies.

Christophers Smile are committed to continue their work to increase the survival of children diagnosed with cancer by supporting our life-saving research. The charity also campaigns to improve access to new targeted drugs for children.

Reflecting on the achievements of the past ten years, Professor Chesler said:

I couldnt be prouder of the work we have carried out, which would have not been possible without the Capels and their charity, Christophers Smile.

I have had the pleasure of working with them for over a decade and their funding has been instrumental in bringing new developments and treatments closer to children and their families. I am extremely grateful for their unwavering dedication and Im inspired by how theyve been able to take their grief and turn it into something capable of changing childrens lives.

We have delivered really exciting discoveries and started new and fruitful developments in these past years. Im excited about how far weve come - but there is still a long way to go and we continue to work so that, hopefully one day, we can defeat childrens cancer.

More here:
How a decade of research progress offers hope to children with neuroblastoma - The Institute of Cancer Research

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DAYTON, Ohio (WDTN) At the start of the pandemic, with gyms closed and staying home becoming more of a norm, personal health and fitness goals may have fallen by the wayside.Sports medicine physician with Premier Health, Dr. Aloiya Earl, said some people are still battling the unpleasant side effects of those unhealthy habits, and she said its not too late to get back on track.

Were sitting with our pantry and our refrigerator very accessible, right there, everyday. So it was a very common thing that many people gained weight during the early part of the pandemic and are still struggling with that.

Earl said those whove fallen victim to losing sight of their health goals and stress eating are not alone, explaining that people often find comfort in indulging in tasty, and often unhealthy foods.

When our bodies are stressed, it increases a hormone in our bodies called cortisol, Earl said. Its called the stress hormone, and it makes us crave calories for one, but specifically, it makes us crave like processed, carbohydrate, refined, sugary-type calories. Those things that are sitting our cupboard that are really easy to just grab like chips and sweets, candies.

While theyre satisfying in the moment, they dont offer many positives down the line.

They kind of quell your stress very short-term, but long-term, it can kind of lead to more of that weight gain and even more stress as a snowball effect, Earl said.

She said thats because after enjoying those sweets and unhealthy options, physical changes could give way to emotional ones.

The psychological toll is a really important thing to consider because not only are we dealing with this pandemic, something that none of us has ever with before, which is stressful in and of itself, were dealing now with the anxiety over our own behaviors during the pandemic.

She added, with some people losing or having to switch jobs, as well as the sudden change in exercise and eating habits, a whole new layer of psychological stress begins to develop. But there are feasible options for getting back on track, starting with adopting healthy eating habits.

Manager of The Culinary Center at Dorothy Lane Market, Peggy Neary, said making healthy choices isnt difficult, but requires dedication to small, consistent changes.

Whole wheat pasta rather than just regular pasta is a great idea. Theres more fiber in it, or better for you. Stick to whole grains, Neary said. Make your own salad dressing. Put vegetables on your sandwiches. Use whole grain bread. Things like that.

She added, substitution for your favorite foods is key to remaining motivated, trading sugary foods like ice cream for plain yogurt with berries, or another healthy alternative youre sure to enjoy.

Snack-wise, you can make your own granola. Popcorn is probably a great snack especially if you make it yourself and of course limit the butter, Neary said.

When in doubt she added, starting in the produce section and shopping the perimeter of most grocery stores will offer exposure to options that more closely align with health goals in comparison to other items in the store.

Filling your pantry with healthy food items and purging sugary, salty and processed foods can help cement these changes.

Dr. Earl said if youve fallen off the bandwagon, walking is an easy and effective way to burn fat while doing other activities, like listening to music or podcasts, or talking to a friend. This can serve as a launch pad to new, healthier activities in the future.

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Premier Health physician says stress eating is common during pandemic, offers tips for healthier habits - WDTN.com

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Administration of the CDK4/6 inhibitor, abemaciclib, in combination with standard endocrine therapy to patients with high-risk, hormone receptor-positive, HER2-negative, early-stage breast cancer following completion of primary treatment was associated with an approximately 25% reduction in the risk of developing a recurrence of invasive disease, according to results of a preplanned interim analysis of a phase 3 study. These findings were presented at the European Society of Medical Oncology (ESMO) Virtual Congress 2020 and simultaneously published in the Journal of Clinical Oncology.1,2

Despite high rates of cure in patients with early-stage invasive breast cancer treated with standard therapies, such as chemotherapy, radiation therapy, and endocrine therapy, a substantial minority of patients with disease characterized by high-risk features, such as 4 or more positive lymph nodes, histologic grade 3 disease, and large tumor size, will experience disease recurrence. Hence, there is a need for new therapeutic approaches in this setting.

Abemaciclib plus endocrine therapy in the adjuvant setting is was explored based on its efficacy and safety in the metastatic setting in this breast cancer subtype.

This study was an open-label phase 3 trial (monarchE; ClinicalTrials.gov Identifier: NCT03155997) in which adult patients with high-risk, early-stage, hormone receptor-positive, HER2-negative invasive breast cancer were randomly assigned in a 1:1 ratio to receive adjuvant endocrine therapy either alone or in combination with the CDK4/6 inhibitor, abemaciclib, with the latter agent administered for 2 years following completion of primary therapy (that must have included surgery).

High-risk disease was characterized by 4 or more positive lymph nodes, or 1 to 3 positive lymph nodes in the setting of a tumor of at least 5 cm, grade 3 or centrally confirmed Ki-67 expression of at least 20% in untreated breast tissue.

The primary study endpoint was invasive disease-free survival (IDFS), with secondary study endpoints including distant relapse-free survival (DRFS), overall survival (OS), and safety.

The 5637 patients in the intention-to-treat (ITT) population were stratified according to prior chemotherapy, menopausal status, and region of treatment. Choice of standard endocrine therapy was based on physician choice.

The median patient age was 51 years, more than 99% of patients were female, and nearly 95% had received either neoadjuvant (37%) or adjuvant chemotherapy (approximately 58%) at baseline.

At a median follow-up of 15.5 months, there was a significantly higher rate of 2-year IDFS in patients receiving abemaciclib plus endocrine therapy (92.2%) compared with endocrine therapy alone (88.7%), with a hazard ratio (HR) for IDFS of 0.747 (95% CI, 0.598-0.932; P =.0096).

Furthermore, this benefit was observed across all prespecified subgroups, including whether patients had received prior chemotherapy or not, and whether they were classified as pre- or postmenopausal.

Similarly, 2-year DRFS was 93.6% for patients treated with the combination vs 90.3% for those receiving endocrine therapy alone, with a HR for DRFS of 0.717 (95% CI, 0.559-0.920). Thus, the risk of recurrence was reduced by 28.3%. This represents a 3.3% absolute difference. According to the presentation slides, the greatest reduction in distant metastases was to the liver and bone.

Regarding safety, no new safety signals were associated with administration of abemaciclib in the adjuvant setting compared with its US Food and Drug Administration (FDA)-approved use in combination with endocrine therapy in patients with advanced hormone receptor-positive, HER2-negative disease.3

Specifically, grade 3 or higher diarrhea, neutropenia, and leukopenia were more common in patients treated with combination therapy. In addition, the incidences of venous thrombotic events, interstitial lung disease and febrile neutropenia, AEs of interest, were more frequent in patients treated with abemaciclib, but low in both study arms. Interestingly, the frequency of all-grade arthralgia and hot flushes were lower in the combination arm compared with endocrine therapy alone. The treatment discontinuation rates due to adverse events in the abemaciclib and control arms were 16.6% and 0.8%, respectively.

In his concluding remarks, presenter Stephen R. Johnston, MD, professor of breast cancer medicine at The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, London, United Kingdom, stated that abemaciclib is the first CDK4/6 inhibitor to show a significant improvement in IDFS when combined with endocrine therapy in patients with hormone-positive early-breast cancer.1

According to an ESMO press release on the findings from this study, Giuseppe Curigliano, MD, PhD, associate professor of medical oncology at the University of Milan, Italy, and chair of the ESMO Guidelines Committee, noted that for the future it will be important to understand if we can potentially spare chemotherapy in this group of patients treated with a CDK4/6 inhibitor. This would need to be investigated in a [randomized] clinical trial.4

Disclosures: Research funding for this study was provided by Eli Lilly and Co. Some of the presenters reported financial relationships with the pharmaceutical industry. For a full list of disclosures, please refer to the original abstract.

Read more of Cancer Therapy Advisors coverage of the ESMO Virtual Congress 2020 by visiting the conference page.

References

See original here:
Addition of a CDK4/6 Inhibitor to Adjuvant Endocrine Therapy Improves Outcomes in HR+, HER2-, High-Risk Early Breast Cancer - Cancer Therapy Advisor

Recommendation and review posted by Bethany Smith

Sweating a ton can truly be the pits. Just ask country pop-singer and reality star Jessie James Decker, who recently posted a photo to her Instagram airing out her own troubles with excess sweat.

The 32-year-old candidly showed her fans what happens after spending a day talking to the press on Zoom from the comfort of her own home: a whole lot of armpit sweat. In fact, Decker (who recently released a cookbook) posed for the image complete with what appears to be toilet paper (or maybe napkins?) wadded up against her underarms. While it makes for a pretty funny post, the fact is that excessive perspiration is a problem encountered by many people, and maybe its time someone drew attention to it.

Excessive sweating is also known as hyperhidrosis and affects about 4.8 percent of the U.S. population. The condition can be spread throughout your body, or it may be localized in certain areas. Some common areas in which to experience excess sweat include the palms of your hands, the soles of your feet, your face, and as in Deckers case, your armpits.

While everyone sweats to a certain extent (especially after exercise, when its particularly hot out, or even when youre nervous), if it goes beyond that, then youre dealing with at least primary hyperhidrosis. That means that you can be sitting on the couch watching television and feel sweat collecting on your forehead or suddenly see your palms dripping when youre simply driving home from work with the air conditioning on.

Secondary hyperhidrosis, however, means theres actually an underlying condition thats causing your body to produce more sweat than is needed to simply cool down the body. While Decker didnt share more details about why she may be sweating so much (from the post, it sounds like shes still unsure), these are some of the conditions that can be associated with an overproduction of sweat: glucose control disorders, lung disease, stroke, menopause, tuberculosis, Parkinson's disease and hormone-related conditions like an overactive thyroid, pheochromocytoma (a tumor on the adrenal gland tumor) and acromegaly. It can also point to cancer, as well as carcinoid syndrome (when a tumor releases chemicals into the bloodstream). But sometimes its simply due to an anxiety disorder or due to the use of certain medications, as well as to substance abuse.

If, like Decker, youre bothered by your bodys excess sweat, its likely time to go and see a doctor. A physician may request a number of tests, including a starch iodine test (which turns sweat brown in order to more easily track just how much youre sweating and whether any of it is beyond the usual), as well as use of a vapometer, which measures how much water is lost via your feet, scalp, hands, and armpits. Blood work and imaging tests might also be ordered if hormone issues or tumors are suspected.

The good news for folks like Decker is that once the root cause is determined, there are a number of ways to try and alleviate symptoms. For excess underarm sweat (as in Deckers case), a stronger prescription antiperspirant may just do the trick. There are also prescription creams to try, as well as nerve-blocking medications that may reduce sweat, and botulinum toxin injections (such as Botox) which can serve as temporary nerve blocks. In more severe cases, individuals may consider surgical remedies such as sweat gland removal (for underarms), and nerve surgery (for extremely sweaty hands and a few other areas).

If youre not ready to make such a drastic commitment, lifestyle changes like wearing shoes, socks, and clothing made of natural materials like cotton, leather, silk, and wool; as well as daily bathing, using astringents on sweaty areas, and relaxation techniques (if your sweating is anxiety-related) may all be helpful. But if youre in a pinch, Deckers napkins under the pits technique might at least help get you by.

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Jessie James Decker has an excessive sweating problem. Heres what that could mean. - Yahoo Sports

Recommendation and review posted by Bethany Smith

Adding the CDK4/6 inhibitor abemaciclib (Verzenio) to endocrine therapy significantly reduces the risk of early recurrence in high-risk hormone receptor positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative breast cancer, suggests a preplanned interim analysis of a phase 3 trial.

The research was presented September 19 at the ESMO Virtual Congress 2020 and simultaneously published in the Journal of Clinical Oncology.

The monarchE trial compared 2 years of abemaciclib plus endocrine therapy vs endocrine therapy alone among 5600 patients and found that the combination was associated with a 25% relative risk reduction in the primary endpoint invasive disease-free survival (P =.0096; HR, 0.75; 95% CI, 0.60 - 0.93)

At 2 years, the rate of invasive disease-free survival was 92.2% in the abemaciclib arm vs 88.7% in the group that took endocrine therapy alone.

"This is the first time in more than 20 years that we have seen an advance in the adjuvant treatment of this form of breast cancer," said lead investigator Stephen Johnston, MD, PhD, from the Royal Marsden Hospital NHS Foundation Trust in London, UK, in a meeting press release.

Dr Stephen Johnston

He told Medscape Medical News that the high-risk patients in their study "are predicted to relapse quite quickly," as a result of having a degree of endocrine resistance, "and by intervening early we are stopping these recurrences within the first 2 years."

He continued: "The key issueis whether you need 2 years of treatment or perhaps even longer. One other trial is looking at 3 years with another drug and we'll just have to await further follow-up of the data to see if the [monarchE] curves continue to separate while on treatment."

According to Giuseppe Curigliano, MD, PhD, head of the Division of Early Drug Development at the European Institute of Oncology, Milan, Italy, "This is a very important trial and the findings will change practice. Once approved for high risk HR+ HER2-negative early breast cancer, the new standard of care for these patients will be to add two years of abemaciclib to endocrine therapy."

Curigliano, who was not involved with the study, further commented during a meeting press conference that a randomized trial will be needed to answer a new important question: Can these high-risk patients treated with a CDK4/6 inhibitor be spared chemotherapy?

Investigator Johnston pointed out that many patients diagnosed with HR+, HER-2 breast cancer will not experience recurrence with standard-of-care therapies.

But he also explained "that up to 20% may develop recurrence or distant relapse in the first 10 years," and that the risk of recurrence is "much greater" for patients who have high-risk clinical or pathological features, "especially during the first few years on their adjuvant endocrine therapy."

Abemaciclib was approved by the US Food and Drug Administration in 2017 and is approved in combination with the endocrine therapy fulvestrant for the treatment of HR+, HER2-negative advanced or metastatic breast cancer that has progressed after endocrine therapy.

The approval was in-part based on data from the MONARCH-2 trial, which showed consistent overall survival benefits with the combination.

MonarchE, on the other hand, examined the impact of abemaciclib in the first-line adjuvant setting, enrolling patients with HR+, HER2-negative, node-positive early breast cancer who had a tumor size of 5 cm, histologic grade 3 disease, and/or Ki67 index of 20%.

They were randomly assigned in a 1:1 fashion to abemaciclib 150 mg twice daily for up to two years plus standard of care endocrine therapy or standard of care endocrine therapy alone.

The choice of endocrine therapy was left to the physician and was continued for 5-10 years, as clinically indicated.

The trial included 5637 patients. An efficacy interim analysis was planned for when 75% of the estimated invasive disease-free survival events had occurred, which equated to 323 events in the intention-to-treat population.

This occurred after approximately 15.5 months of follow-up in each arm, when 12.5% of patients had completed the two-year treatment period, leaving 70% still in treatment.

The intention-to-treat population included 2808 patients from the abemaciclib plus endocrine therapy group and 2829 in the group taking endocrine therapy alone.

The two groups were well balanced in terms of their baseline characteristics. The vast majority (approximately 85%) of patients were younger than age 65 years, and 56.5% were postmenopausal.

Also, 37% had previously received neoadjuvant chemotherapy and approximately 58% adjuvant chemotherapy.

Distant relapse-free survival was also significantly reduced with abemaciclib plus endocrine therapy vs endocrine therapy alone, at a hazard ratio of 0.72 (P = .0085), and a two-year rate of 93.6% and 90.3%, respectively.

Johnston highlighted that not only was the number of patients with distant recurrences reduced with the combination therapy, at 92 vs 142 with endocrine therapy alone, but also the reductions were in key locations.

The number of patients with recurrences in the bone were 32 with abemaciclib and 81 with endocrine therapy alone; 29 patients with abemaciclib and 42 with endocrine therapy alone had recurrences in the liver.

The results show that the most frequent adverse events in the abemaciclib arm were diarrhea (82%), neutropenia (45%), and fatigue (38%), whereas arthralgia (31%), hot flush (21%), and fatigue (15%) were seen most often in the control group.

A venous thromboembolic event was recorded in 2.3% of patients in the abemaciclib group versus 0.5% of those on endocrine therapy alone; interstitial lung disease was seen in 2.7% and 1.2%, respectively.

Despite the protocol allowing dose reductions from 150 mg to 100 mg twice daily if required, 463 (16.6%) patients discontinued abemaciclib as a result of adverse events. Of those, 306 continued on endocrine therapy.

"Adherence to treatment will be an important issue to be considered in the real-life population of patients when this treatment is approved and used in clinical practice," Johnston said.

Nevertheless, diarrhea frequency and severity decreased significantly over time and only 4.8% of the abemaciclib group discontinued use as a result of this adverse event.

George W. Sledge Jr, MD, professor of medicine (oncology) at Stanford University Medical Center, Palo Alto, California, was the invited discussant after the presentation.

He said that "positive trails raise as many questions as they answer, and monarchE is no exception."

For example, there is the conundrum posed by the negative results of the very similar PALLAS trial, which looked at the addition of palbociclib to adjuvant endocrine therapy for HR+, HER2-negative early breast cancer, and was also presented at the ESMO meeting.

Returning to monarchE, Sledge asked what the ultimate increase in invasive disease- and distant relapse-free survival will be with the drug combination, noting that the trial has "very, very short follow-up."

"Second, will the improvements seen in disease-free survival lead to what we really care about: improved overall survival? Again, time will tell, but healthcare systems and patients care deeply about the answer to this question."

Sledge continued: "How about late recurrence? Do CDK4/6 inhibitors kill off dormant or slow-growing micro-mets that lead to recurrences 5 or more years out?"

He also asked what the optimum duration therapy would be: "Is it more than we need, or not enough?"

Sledge wondered whether it is possible to determine who benefits "and why the drug fails some patients."

Finally, Sledge said, "These drugs are expensive2 years of adjuvant therapy is simply out of reach for the majority of patients around the globe who might be candidates for adjuvant CDK4/6 inhibitor therapy."

And he observed an important truism: "A patient cannot benefit from a drug she cannot take."

The study was funded by Eli Lilly and Company. Johnston, Sledge, and Curigliano have financial ties to Eli Lilly and multiple other drug companies.

ESMO Virtual Congress 2020: Abstract LBA5_PR. Presented September 19, 2020.

J Clin Oncol. Published online September 19, 2020. Full text

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Read more:
Abemaciclib Cuts Early Recurrence in High-risk Breast Cancer - Medscape

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