Sept. 28, 2020 11:00 UTC

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- AVROBIO, Inc. (Nasdaq: AVRO), a leading clinical-stage gene therapy company with a mission to free people from a lifetime of genetic disease, today announced that the European Commission (EC) has granted orphan drug designation for AVR-RD-02, the companys investigational gene therapy for the treatment of Gaucher disease. AVR-RD-02 consists of the patients own hematopoietic stem cells, genetically modified to express glucocerebrosidase (GCase), the enzyme that is deficient in Gaucher disease. AVROBIO recently dosed the first patient in the GuardOne Phase 1/2 clinical trial to evaluate the safety and efficacy of AVR-RD-02.

Like many lysosomal disorders, Gaucher disease can lead to debilitating complications throughout the body and brain. The standard of care does not address all these symptoms and may not be able to halt progression of the disease, said Geoff MacKay, AVROBIOs president and CEO. Our investigational gene therapy is designed to address the head-to-toe manifestations of Gaucher disease with a single dose. Were pleased to receive orphan drug designation, which recognizes the potential of our approach to transform the standard of care and, we hope, the quality of life for people living with this rare genetic disorder.

The EC grants orphan drug designation to drugs and biologics intended for the safe and effective treatment, diagnosis or prevention of rare diseases or conditions that impact fewer than 5 in 10,000 patients in the European Union. Orphan drug designation gives companies certain benefits, including reduced regulatory fees, clinical protocol assistance, research grants and 10 years of market exclusivity following regulatory approval.

AVR-RD-02 has also received orphan drug designation from the U.S. Food and Drug Administration.

About Gaucher Disease

Gaucher disease is a rare, inherited lysosomal storage disorder characterized by the toxic accumulation of glucosylceramide (GlcCer) and glucosylsphingosine (GlcSph) in macrophages. Macrophages bloated with these fatty substances are called Gaucher cells which amass primarily in the spleen, liver and bone marrow. This results in a variety of potential symptoms, including grossly enlarged liver and spleen, bone issues, fatigue, low hemoglobin levels and platelet counts and an adjusted lifetime relative risk of developing Parkinson's disease that may be more than 20 times greater than the general population. Even on enzyme replacement therapy (ERT) the current standard of care people with Gaucher disease type 1 typically have a shortened life expectancy and may experience debilitating symptoms that significantly reduce their quality of life. An estimated 1 in 44,000 people are diagnosed with Gaucher disease.

About AVR-RD-02

AVR-RD-02 is an investigational lentiviral gene therapy designed to provide a durable therapeutic benefit for people living with Gaucher disease. The therapy starts with the patients own hematopoietic stem cells, which are genetically modified to express functional glucocerebrosidase (GCase). Functional GCase reduces levels of glucosylceramide and glucosylsphingosine, the accumulated substances which cause the symptoms of Gaucher disease. AVROBIO is currently evaluating AVR-RD-02 in GuardOne, a Phase 1/2 clinical trial.

About lentiviral gene therapy

Lentiviral vectors are differentiated from other delivery mechanisms because of their large cargo capacity and their ability to integrate the therapeutic gene directly into the patients chromosomes. This integration is designed to maintain the therapeutic genes presence as the patients cells divide, which potentially enables dosing of pediatric patients, whose cells divide rapidly as they grow. Because the therapeutic gene is integrated into the patients own stem cells, patients are not excluded from receiving the investigational therapy due to pre-existing antibodies to the vector.

About AVROBIO

Our vision is to bring personalized gene therapy to the world. We aim to halt or reverse disease throughout the body by driving durable expression of functional protein, even in hard-to-reach tissues and organs including the brain, muscle and bone. Our clinical-stage programs include Fabry disease, Gaucher disease and cystinosis and we also are advancing a preclinical program in Pompe disease. AVROBIO is powered by the plato gene therapy platform, our foundation designed to scale gene therapy worldwide. We are headquartered in Cambridge, Mass., with an office in Toronto, Ontario. For additional information, visit avrobio.com, and follow us on Twitter and LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words and phrases such as aims, anticipates, believes, could, designed to, estimates, expects, forecasts, goal, intends, may, plans, possible, potential, seeks, will, and variations of these words and phrases or similar expressions that are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements regarding our business strategy for and the potential therapeutic benefits of our prospective product candidates, including AVR-RD-02 for the treatment of Gaucher disease; the anticipated benefits of the European Commissions grant of orphan drug designation for AVR-RD-02; the design, commencement, enrollment and timing of ongoing or planned clinical trials and regulatory pathways; the timing of patient recruitment and enrollment activities, clinical trial results, and product approvals; the anticipated benefits of our gene therapy platform including the potential impact on our commercialization activities, timing and likelihood of success; the expected benefits and results of our implementation of the plato platform in our clinical trials and gene therapy programs; and the expected safety profile of our investigational gene therapies. Any such statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Results in pre-clinical or early-stage clinical trials may not be indicative of results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements, or the scientific data presented.

Any forward-looking statements in this press release are based on AVROBIOs current expectations, estimates and projections about our industry as well as managements current beliefs and expectations of future events only as of today and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that any one or more of AVROBIOs product candidates will not be successfully developed or commercialized; the risk of cessation or delay of any ongoing or planned clinical trials of AVROBIO or our collaborators; the risk that AVROBIO may not successfully recruit or enroll a sufficient number of patients for our clinical trials; the risk that AVROBIO may not realize the intended benefits of our gene therapy platform, including the features of our plato platform; the risk that our product candidates or procedures in connection with the administration thereof will not have the safety or efficacy profile that we anticipate; the risk that prior results, such as signals of safety, activity or durability of effect, observed from pre-clinical or clinical trials, will not be replicated or will not continue in ongoing or future studies or trials involving AVROBIOs product candidates; the risk that we will be unable to obtain and maintain regulatory approval for our product candidates; the risk that the size and growth potential of the market for our product candidates will not materialize as expected; risks associated with our dependence on third-party suppliers and manufacturers; risks regarding the accuracy of our estimates of expenses and future revenue; risks relating to our capital requirements and needs for additional financing; risks relating to clinical trial and business interruptions resulting from the COVID-19 outbreak or similar public health crises, including that such interruptions may materially delay our development timeline and/or increase our development costs or that data collection efforts may be impaired or otherwise impacted by such crises; and risks relating to our ability to obtain and maintain intellectual property protection for our product candidates. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause AVROBIOs actual results to differ materially and adversely from those contained in the forward-looking statements, see the section entitled Risk Factors in AVROBIOs most recent Quarterly Report, as well as discussions of potential risks, uncertainties and other important factors in AVROBIOs subsequent filings with the Securities and Exchange Commission. AVROBIO explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200928005176/en/

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AVROBIO Receives Orphan Drug Designation from the European Medicines Agency for AVR-RD-02, an Investigational Gene Therapy for Gaucher Disease -...

Recommendation and review posted by Bethany Smith

NEWARK, Del., Sept. 24, 2020 /PRNewswire/ --Neurophth Therapeutics, Inc., (hereinafter referred to as "Neurophth") today announced that its leading candidate, NR082 (rAAV2-ND4, NFS-01 project), was granted an orphan drug designation (ODD) by the U.S. FDA for the treatment of Leber's Hereditary Optic Neuropathy associated with ND4 mutation.

Leber's Hereditary Optic Neuropathy (LHON) is a maternally inherited mitochondrial disease, characterized by acute or subacute, painless vision loss or even loss simultaneously or sequentially, accompanied by central visual field defect and color vision impairment with poor prognosis. It was first reported by German scholar Leber in 1871. It affects about 1-9:100,000 people worldwide. LHON is one of the blinding diseases. The disease mainly occurs in young- and middle-aged men. Currently, there is no effective treatment for LHON. About 70% - 90% of LHON is caused by ND4 mutation of harboring a point mutation at nucleotide 11778 associated with a G-to-A transition. With the development of NR082, AAV-based gene therapy of LHON becomes possible.

"Due to the lack of effective treatment, the quality of life of LHON patients associated with ND4 mutation is very poor, and a huge unmet medical needs have not been fulfilled," said Dr. Alvin Luk, Chief Executive Officer at Neurophth. "NR082 is the first candidate drug developed by Neurophth. It uses recombinant adeno-associated virus serotype 2 to deliver the genetically modified ND4 gene (rAAV2-ND4). After a single intravitreal injection, the gene is translated and expressed in cells, which effectively supplements the function loss caused by endogenous mutation. Through this gene therapy, the electron transport function of mitochondrial respiratory chain was maintained, and the increase of ATP synthesis restored the normal function of mitochondria, which in turn improved the sensory function of the retinal ganglion cells and improved the visual acuity of LHON patients."

Luk added, "the significance of orphan drug designation is that regulators recognize the unmet medical needs of rare diseases like LHON. The recognition of NR082 will reduce the R&D investment to a certain extent and accelerate the progress of clinical trials and marketing registration. Furthermore, Neurophth is committed to fundamentally solve the causes and change the quality of life of patients through a single treatment of gene therapy."

Professor Bin Li, Founder, Chairman and Chief Scientific Officer at Neurophth, said: "NR082 has been granted as orphan drug by U.S. FDA, which further strengthens our focus on gene therapy for rare ophthalmic diseases, and develops more drugs for treatment of ocular genetic diseases, bringing hope to patients with ocular genetic diseases in the world".

*FDA grants orphan drug designation to drugs and biological products designed to safely and effectively treat, diagnose, or prevent rare diseases or conditions affecting less than 200,000 people in the US. According to the Orphan Drug Act of FDA, Orphan Drug Designation (ODD) provides opportunities for grant funding, fast approval channel, and some incentives, such as waiver of New Drug Application (NDA) fees, tax credits for clinical trial expenses and exemption for prescription drug users' fees as well as the products are entitled to a seven-year of market exclusivity and will not be affected by patents.

About NR082 (rAAV2-ND4; NFS-01 Project)

LHON disease is caused by mutations in mitochondrial DNA 11778, 14484 or 3460. ND4 gene of 11778 G>A mutation is the main pathological factor, which exists in 55-70% of European and American patients and 90% of Chinese patients. NR082 (NFS-01 project) is an innovative candidate drug for ophthalmic AAV-based gene therapy. It uses AAV2 vector to express human ND4 gene in the retinal ganglion cells to repair optic neuropathy caused by 11778 G>A mutation.

As early as 2011, Professor Bin Li's team started the world's first LHON gene therapy investigator-initiated trial (IIT) with this candidate drug. Nine subjects who participated in the clinical trial have been followed up for up to 8 years with no serious adverse reactions, and 5 of them have significant improvement in their vision. This result is the longest follow-up record of gene therapy in the world, which has already been published in the Scientific Report, EBioMedicine and Ophthalmology journals, and has fully proven the long-term safety, effectiveness, and durability of AAV gene therapy in clinical settings.

After the gratifying results of the first study, Professor Li's team conducted a more comprehensive IIT clinical study from 2017 to 2018, with 159 subjects (including 10 subjects from Argentina), which is the largest clinical trial in the entire gene therapy in the world. Among those, 143 of the patients has completed the 12-month follow-up and 56.6% showed a significant BCVA (best-corrected visual acuity improved by at least 0.3 LogMAR) improvement. No serious adverse reaction was found. In May 2020, at the 23rd online annual meeting of the American Society for Gene and Cell Therapy (ASGCT) and the online annual meeting of the Association for Research in Vision and Ophthalmology (ARVO), Neurophth presented these two clinical research data on the treatment of LHON with NR082 (NFS-01 project of rAAV2-ND4), demonstrating the international advanced level of this research in the field of gene therapy.

Following the positive results of these two IIT trials, Neurophth is actively preparing the China/U.S. IND (Investigational New Drug) applications, and plans to carry out the registration clinical Phase 1/2/3 registration trial to evaluate the safety, efficacy and durability of NR082.

About Neurophth

As a clinical-stage R & D company, Neurophth is committed to exploring and developing new therapies for global patients with ophthalmic diseases. With the help of the mature AAV ophthalmic gene therapy technology platform and the deep understanding of the ophthalmology field by the founding team for decades, Neurophth has established a rich, robust product pipeline, including more than 10 research projects for various ophthalmic diseases, such as dominant hereditary optic atrophy, optic nerve injury diseases, vascular retinopathy, etc., and gradually expanded from rare to common ophthalmic diseases. Additionally, the company is preparing to build a GMP commercial production platform for gene therapy drugs accordance with the international quality standards, and plans to build an ophthalmic gene therapy transformational excellence center, aiming to become a global leader in gene therapy in ophthalmology to benefit patients all over the world.

Prospect of Gene Therapy in Ophthalmology

Inherited retinal diseases (IRDs) have long been regarded as an ideal disease area for gene therapy, because most of the gene mutations leading to the disease have been identified (more than 200 gene defects are associated with the most common IRDS). The eye is, to some extent, an immune privilege. Clinical trials have shown that gene therapy using adeno-associated virus (AAV) or lentivirus (LV) vectors in the eye does not cause systemic side effects and does not cause significant immune responses. The most common IRDs were Retinitis Pigmentosa (RP), Achromatopsia color blindness (ACHM), Leber Hereditary Optic Neuropathy (LHON), Leber Congenital Amaurosis (LCA), Stargardt disease and X-linked Retinoschisis (XLRS).

To date, only one ophthalmic AAV gene therapy product has been approved in the world, namely the first AAV2 gene therapy voretigene neparvovec-rzyl (LUXTURNA; Spark Therapeutics) approved by FDA in December 2017 to treat IRD caused by RPE65 double allele mutation in adult or pediatric patients. The approval of LUXTURNAhas brought confidence and hope to the global ophthalmic gene therapy field. Public information disclosed that at least 20-30 kinds of gene therapy for ophthalmic diseases are in the research and development stage, and the international representative companies include Applied Genetic Technologies Corporation and Meira GTX, and new companies represented by Neurophth have also begun to enter the international stage of ophthalmic gene therapy.

References

Contact:Dr. Alvin LukAlvin.Luk@neurophth.com

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SOURCE Neurophth Therapeutics, Inc.

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Neurophth Therapeutics' Treatment of Leber's Hereditary Optic Neuropathy Gene Therapy NR082 was Granted Orphan Drug Designation by US FDA - BioSpace

Recommendation and review posted by Bethany Smith

SHANGHAI, Sept. 28, 2020 /PRNewswire/ -- On September 25, 2020, BIORAY LABORATORIES Inc. ("Bioraylab"), a company specialized in gene therapy and cell drug R&D, announced for the first time that clinical trials of non-viral PD1 specific targeted CAR T therapy in relapsed/refractory B-cell non-Hodgkin lymphoma, undertaken by the company in cooperation with East China Normal University and the First Affiliated Hospital, School of Medicine, Zhejiang University, has achieved significant breakthroughs. This is the world's first application of gene editing technology to realize PD1-knockin CAR T treatment, and is also the world's first clinical trial treating lymphoma with non-viral PD1 specific targeted CAR T cells.

The latest research results, finished by East China Normal University, the First Affiliated Hospital, School of Medicine, Zhejiang University and Bioraylab, were announced on the preprint platform medRxiv on September 23, 2020.

PD1 specific targeted CD19-CARTis Bioraylab's Quikin CART platform technology using its proprietary IP, precisely inserting CAR cassette into PD1 locus without using virus, thus generating the CAR T product in just one step. The product combines PD1 immune checkpoint inhibition with CART anti-tumor activity, generating effects of both anti-PD1 immunotherapy and CAR T therapy. Several ongoing clinical trials demonstrate the outstanding safety and effectiveness of this CAR T product.

Two patients showed complete remission following a three-month treatment

The clinical trial program enrolled 15 patients, among which, four patients who were able to be evaluated showed partial remission (PR) after receiving the one-month treatment, while two patients showed complete remission (CR) after three months of treatment.

There were no CAR T cell related high-grade (3) adverse eventsduring the entire treatment, including cytokine release syndrome (CRS)and neurologic toxicity. After infusion, the CAR T cells were well sustained in vivo.

The Quikin CART technology produces CAR T cells without using virus, greatly reducing high costs of producing CAR T products, while avoiding the cancer risk from random insertion. The regulation of T cell endogenous genes and the constant expression of CAR are realized in just one step. Compared with other CAR T technologies, Quikin CART has a variety of advantages, including a simpler process, fewer production links, shorter time preparation and higher product uniformity.

Liu Mingyao, chief scientist at Bioraylab and professor at East China Normal University, said, "Without using virus, the Quikin CART technology can realize the precise integration of CAR cassette into genome as well as regulation of T cell endogenous genes in just one step, delivering many unparalleled advantages compared with existing CAR T technologies. The technology offers a strong platform for the development of more diverse CAR T products in the future."

Huang He, the project investigator of this clinical trial and chairman of the First Affiliated Hospital, School of Medicine, Zhejiang University, commented, "The current results showed that the non-viral PD1-knockin CAR T cellsproduced by using the Quikin CART technology have great potential to treat patients. We are very delighted to see patients rapidly show CR after treatment, and are looking forward to safer and more durable long-term effects on relapsed/refractory patients through this novel CAR T technology."

In addition to the ongoingclinical trials of non-viral PD1 specific targeted CD19-CART, Bioraylab is conducting research on other non-viral specific targeted CART products for treating solid tumors, with the aim of achieving more breakthroughs in CAR T therapy.

About Bioraylab

Founded in Shanghai in 2013, BiorayLaboratories Inc.("Bioraylab")is already well positioned to become the world's leading gene cell pharmaceutical manufacturer, by way of innovation with gene editing and the development of breakthrough therapies that benefit all mankind. Bioraylab owns 108 patents, conductedIIT trials for fiveprojects in eightof the world's leadinghospitals, three of which having entered the IND application stage. Bioraylab has, over the past five years, published 12 high-level academic papers in internationally renownedjournals, including Nature Biotechnology and Nature Medicine. The firmhas built three technology platforms for gene editing, cell therapy and gene therapy, and has a 6,000-square-meter GMP pilot plant and an operating team comprising nearly 100 people, placing the firm in the position of being able to guarantee the rapid transformation and application of innovative research results.

Read more:
World's first clinical trial of non-viral PD1 specific targeted CAR T therapy achieves great breakthroughs - WFMZ Allentown

Recommendation and review posted by Bethany Smith

Timothy Ray Brown, the first person known to have been cured of HIV infection, says he is now terminally ill from a recurrence of the cancer that prompted his historic treatment 12 years ago.

Brown, dubbed "the Berlin patient" because of where he lived at the time, had a transplant from a donor with a rare, natural resistance to the AIDS virus. For years, that was thought to have cured his leukemia and his HIV infection, and he still shows no signs of HIV.

But in an interview with the Associated Press, Brown said his cancer returned last year and has spread widely. He's receiving hospice care where he now lives in Palm Springs, Calif.

"I'm still glad that I had it," Brown said of his transplant. "It opened up doors that weren't there before" and inspired scientists to work harder to find a cure, which many had begun to think was not possible, the 54-year-old said Sept. 24.

"Timothy proved that HIV can be cured, but that's not what inspires me about him," said Dr. Steven Deeks, an AIDS specialist at the University of California at San Francisco, who has worked with Brown to further research toward a cure.

"We took pieces of his gut, we took pieces of his lymph nodes. Every time he was asked to do something, he showed up with amazing grace," Deeks said.

Brown was an American working as a translator in Berlin in the 1990s when he learned he had HIV. In 2006, he was diagnosed with leukemia.

Dr. Gero Huetter, a blood cancer expert at the University of Berlin, believed that a marrow transplant was Brown's best chance of beating the leukemia. He wondered, could he also cure Brown's other life-threatening disease by using a donor with a gene mutation that provides natural resistance to the AIDS virus?

Donors like these are very rare and transplants are risky. Doctors have to destroy the patient's diseased immune system with chemotherapy and radiation, then transplant the donor's cells and hope they develop into a new immune system for the recipient.

Brown's first transplant in 2007 was only partly successful: His HIV seemed to be gone but his leukemia was not. He had a second transplant from the same donor in March 2008 and that one seemed to work.

Since then, Brown has repeatedly tested negative for HIV and has frequently appeared at AIDS conferences where cure research is discussed.

"He's been like an ambassador of hope," said Brown's partner, Tim Hoeffgen.

A second man, Adam Castillejocalled "the London patient" until he revealed his identity earlier this yearalso is believed to have been cured by a transplant similar to Brown's in 2016.

But donors like these are scarce and the procedure is too risky to be widely used.

Scientists have been testing gene therapy and other ways to try to get the effect of the favorable gene mutation without having to do a transplant. At an AIDS conference in July, researchers said they may have achieved a long-term remission in a Brazil man by using a powerful combination of drugs meant to flush dormant HIV from his body.

Mark King, a Baltimore man who writes a blog for people with HIV, said he spoke with Brown recently and is grateful for what Brown has contributed to AIDS research.

"It is unfathomable what value he has been to the world as a subject of science. And yet this is also a human being who is a kind, humble guy who certainly never asked for the spotlight," King said. "I think the world of him."

Read the original post:
First man cured of HIV infection now has terminal cancer - Modern Healthcare

Recommendation and review posted by Bethany Smith

The continuing spread of Coronavirus (COVID-19) amongst major global economies has become an important factor of concern for import and export activities. Learn how companies in the Gene Therapy Industry are responding to the Coronavirus crisis by gaining efficacy in alternative strategies that are stabilizing various business activities. Browse through our latest research analysis on COVID-19 and its impact on the global market landscape.

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The report on the global Gene Therapy market published by Fact.MR provides a clear understanding of the flight of the Gene Therapy market over the forecast period (2020 to 2026). The study introspects the various factors that are tipped to influence the growth of the Gene Therapy market in the upcoming years. The current trends, growth opportunities, restraints, and major challenges faced by market players in the Gene Therapy market are analyzed in the report.

The study reveals that the global Gene Therapy market is projected to reach a market value of ~US$XX by the end of 2026 and grow at a CAGR of ~XX% during the assessment period. Further, a qualitative and quantitative analysis of the Gene Therapy market based on data collected from various credible sources in the market value chain is included in the report along with relevant tables, graphs, and figures.

Relevant Takeaways from Report:

Gene Therapy Segmentation

By Product Type

The report highlights the product adoption pattern of various products in the Gene Therapy market and provides intricate insights such as the consumption volume,

By End-User,

Key Players

The global Gene Therapy market expected to be fragmented due to the low to medium presence of international and local market players. Some of the key players are identified across the value chain of the global Gene Therapy market which is as-

The research report presents a comprehensive assessment of the market and contains thoughtful insights, facts, historical data, and statistically supported and industry-validated market data. It also contains projections using a suitable set of assumptions and methodologies. The research report provides analysis and information according to market segments such as geographies, applications, and industry.

The report covers exhaustive analysis on:

Regional analysis includes:

The report is a compilation of first-hand information, qualitative and quantitative assessment by industry analysts, inputs from industry experts, and industry participants across the value chain. The report provides an in-depth analysis of parent market trends, macro-economic indicators, and governing factors along with market attractiveness as per segments. The report also maps the qualitative impact of various market factors on market segments and geographies.

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The report addresses the following doubts related to the Gene Therapy Market:

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Recommendation and review posted by Bethany Smith

Monday, September 28, 2020

The prospect of genetic engineering using CRISPR (clustered regularly interspaced short palindromic repeats) and CRISPR-associated nucleases (Cas) has long been hailed as a revolutionary development in medicine.

This technology is rapidly advancing, and several CRISPR/Cas-based drugs have entered clinical trials over the past several years. One kind of product in clinical trials is CRISPR-modified cells, such as CTX001 (CRISPR-Cas9-modified autologous hematopoietic stem cells), currently under study for the treatment ofb-thalassemiaand severe sickle cell anemia. Another CRISPR-based product,AGN-151587, is injected into the eye with the goal of eliminating a genetic mutation in patients with Leber congenital amaurosis 10, a leading cause of childhood blindness. In parallel, others are working to harness theCRISPR/Cas system to develop drugs for rare diseases, including bespoketherapiestailored to an individual patients needs.

Given CRISPR/Cas-based drugs potential to treat rare diseases, issues relating to orphan drug exclusivity will arise as these products are developed. In May 2020, for example, CTX001 received anorphan drug designationfor transfusion-dependent b-thalassemia.

In January 2020, the FDA provideddraft guidanceregarding orphan drug exclusivity for gene therapy products, whichincludesCRISPR/Cas gene editing (Draft Guidance). This guidance focuses on the analysis of whether two gene therapy products are the same under the Orphan Drug Act. Although informative, the limited scope of the Draft Guidance invites more questions than it answers.

Obtaining orphan drug exclusivity involves a two-step process. First, a sponsor requests designation of a drug for a particular rare disease or condition.See21 C.F.R. 316.20. If this drug is the same drug as a drug already approved to treat the same rare disease or condition, the sponsor must provide a plausible hypothesis that the new drug is clinically superior to the previously-approved drug.Id.Whether two drugs are the same depends on consideration of structural features relevant to that type of drug.See id. 316.3(b)(14).

If the new drug later obtains marketing approval for a use or indication within the rare disease or condition for which it received orphan drug designation, the FDA will determine if the drug is eligible for orphan drug exclusivity.See21 C.F.R. 316.31(a). In this situation, to receive exclusivity, the sponsor of the new drug must show that its drug is clinically superior to the same previously-approved drug for the same rare disease or condition.See id. 316.34(c). A clinical superiority determination is based on the new drugs greater efficacy, greater safety, or a major contribution to patient care.See id. 316.3(b)(3).

To determine whether one gene therapy product is the same as another, per 316.3(b)(14)(ii), the FDA will evaluate the principal molecular structural features of the two products, particularly transgenes (e.g., transgenes that encode different enzymes for treatment of the same rare disease) and vectors. For example:

If two gene therapy products express different transgenes, the FDA generally intends to consider them to be different drugs even if they have or use the same vector.

Conversely, if two gene therapy products have or use vectors from a different viral class (e.g., gammaretrovirus or adeno-associated virus), the FDA generally intends to consider them to be different drugs even if they express the same transgene.

In the case of two vectors from the same class (e.g., AAV2 or AAV5), the FDA intends to determine their same-ness on a case-by-case basis.

However, the FDA generally does not intend to consider these principal molecular structural features to be different based solely on minor differences between the transgenes and/or the vectors.

Additionally, [w]hen applicable, the FDA generally intends to consider additional features of the final gene therapy product, such as regulatory elements or, in the case of genetically-modified cells, the type of cell that is transduced. It generally intends to consider requests for designation and exclusivity of gene therapy products to evaluate whether such additional features may also be considered to be principal molecular structural features.

The Draft Guidance helps answer certain high-level questions relating to whether two gene therapy products would be considered the same under the Orphan Drug Act. As various stakeholders haverecognized, however, it is short on the details that meaningfully aid the process of drug research and development.

It is clear from the Draft Guidance that a new product can be considered the same as a previously-approved product even if the two products are not perfectly identical, but the guidance does not explain what would constitute a minor difference between such products, or what the scope of additional features would be.

For example, the Draft Guidance does not clarify what makes two transgenes the same. Nor does it cite to prior guidance or regulations that may answer this question. The question is significant becauseCas nucleasesand otherpartsof the CRISPR/Cas system may be modified in various ways. To address whether these modifications bar a finding of same-ness, the FDA could potentially import the kinds of considerations that govern same-ness of other kinds of large-molecule products, such as polynucleotide drugs or closely related, complex partly definable drugs with similar therapeutic intent (e.g., viral vaccines).See21 C.F.R. 316.3(b)(14)(ii)(C), (D). However, this is not clear from the Draft Guidance.

The Draft Guidance also does not explain what will factor into the case-by-case basis assessment of whether viral vectors from the same viral class are the same. In the case of AAV2 and AAV5the two viruses identified in the guidanceresearchers have foundthat these viruses differ with respect to sequence analysis, tissue tropism, and heparin sensitivity. It is not clear from the guidance, however, whether a plausible hypothesis of clinical superiority will be required to seek orphan drug designation for a drug based on AAV2 if the previously-approved drug expresses the same transgene(s) but is based on AAV5.

It would be beneficial to sponsors and other stakeholders if these aspects of gene therapy drugs sameness are clarified further before they invest significant resources into the design and development of these therapeutics.

2020 Proskauer Rose LLP. National Law Review, Volume X, Number 272

More:
Orphan Drug Exclusivity for CRISPR/Cas-Based Therapeutics - The National Law Review

Recommendation and review posted by Bethany Smith

LEIDEN, The Netherlands and SEVILLE, Spain, Sept. 25, 2020 /PRNewswire/ -- Amarna Therapeutics, a Dutch privately held biotechnology company developing the next-generation SV40-based gene delivery vector platform transforming gene-replacement and immunotherapy across many disease areas. The company today announced it has entered into a collaboration with scientists from the Progreso y Salud Foundation (FPS) at Cabimer in Seville, to jointly examine the efficacy of Amarna's SVecTMgene delivery vector to develop effective immunotherapies for diabetes mellitus type 1 (DM1) and multiple sclerosis (MS).

The collaboration is a joint effort between the research group of the FPS at research institute Cabimer, led by Dr. Benoit Gauthier, and Amarna Therapeutics, represented by Dr. Peter de Haan (CSO) and Miguel Garca Toscano (Head of Laboratory in Spain).

To date, the symptoms of DM1 and MS can be managed, but patients cannot be cured from both autoimmune diseases. The aim of this joint effort is to study the efficacy of Amarna's SV40-based gene delivery vector platform, denoted SVecTM, for downregulation of pathological immune responses that underlie the destruction of own cells in DM1 and in MS patients.

The research will focus on the induction of SVecTM-mediated immune tolerance to the primary self-antigens of both diseases. The studies will use advanced animal models of both autoimmune diseases, that have been established by the collaboration partners. Amarna will invest some 0.6 million over the next two years in the Gauthier research group to conduct the animal proof-of-principle studies for these two indications, for which at present there are no cures available.

Benoit Gauthier, Staff Scientist at Junta de Andalucia-Consejeria de Salud y Familias, comments:

"We are thrilled to start this new venture with Amarna Therapeutics, a world leader in viral gene therapy and we anticipate the studies to generate exciting results."

Peter de Haan, Amarna Therapeutic's Chief Scientific Officer, adds:

"We are delighted entering this collaboration with such a renowned academic partner like FPS and we look very much forward to initiate the planned studies. Since the quality of life for patients with DM1 and MS is so severely impaired given the lack of cures for these invalidating diseases, the more efficiently we can develop our groundbreaking SV40-based gene delivery vector basedtherapies, the sooner patients will experience the positive impact of our solution on their lives."

Contact details:

For further inquiries please contact: Amarna Therapeutics Steen Klysner, CEO E-mail: [emailprotected]

LifeSpring Life Sciences Communication, Amsterdam Lon Melens Tel: +31 6 538 16 427 E-mail: [emailprotected]

About FPS

For more than ten years, Benoit Gauthier's research group has focused on the field of diabetes and recently other autoimmune diseases. Its basic quality research has generated important new knowledge which enable the development of new therapies for this disease cluster. An important finding of the group was the mandatory association of immune responses to pancreatic beta cells with their capacity to regenerate in patients with type 1 diabetes. In addition, the discovery of the PAX8 gene, and the relationship between type 2 diabetes (T2D) and increased risk of pancreatic cancer, led to international recognition and generated numerous publications in peer-reviewed scientific journals.

The group is funded by different national and international public and private institutions, as well as from diabetes patient associations and supported by the Andalusian Government.

Amarna Therapeutics

Amarna Therapeutics is a privately held Biotech company founded in 2008. Its head office is located in Leiden (The Netherlands), and it also holds a research facility in Seville (Spain). The company has developed a proprietary production and gene therapy delivery platform in its SuperVeroTM cell line and SVecTM vector for the development of safe and efficient therapies. The company's pipeline targets several major indications as well as orphan diseases within the field of degenerative, inflammatory and autoimmune diseases. The company plans to take the first candidate from its pipeline into clinical development in 2021.

In October 2019, Amarna secured 10 million in new equity, with the aim of bringing the first product into clinical studies. The financing round was led by the Swedish Flerie Invest AB, together with existing shareholders and an innovation credit from the "Netherlands Enterprise Agency" (RVO.nl).

SOURCE Amarna Therapeutics

The rest is here:
Dutch Amarna Therapeutics enters research collaboration with Spanish FPS, examining the efficacy of its SV40-based SVec gene delivery vector platform...

Recommendation and review posted by Bethany Smith

Roots Analysis has announced the addition of Gene Therapy Market (3rd Edition), 2019-2030 report to its list of offerings.

Encouraging clinical results across various metabolic, hematological and ophthalmic disorders have inspired research groups across the world to focus their efforts on the development of novel gene editing therapies. In fact, the gene therapy pipeline has evolved significantly over the past few years, with three products being approved in 2019 alone; namely Beperminogene perplasmid (AnGes), ZOLGENSMA (AveXis) and ZYNTEGLO (bluebird bio). Further, there are multiple pipeline candidates in mid to late-stage (phase II and above) trials that are anticipated to enter the market over the next 5-10 years.

To order this 550+ page report, which features 190+ figures and 355+ tables, please visit this link

Key Market Insights

Around 470 gene therapies are currently under developmentNearly 45% of pipeline drugs are in the clinical phase, while rest are in the preclinical / discovery stage. Gene augmented therapies presently represent 66% of the total number of such interventions that are in the pipeline. It is worth mentioning that majority of such product candidates are being developed as in vivo gene therapies.

More than 30% of clinical stage pipeline therapies are being designed for treating oncological disordersConsidering the overall pipeline, over 20% of product candidates are being developed to treat various types of cancers, followed by those intended for the treatment of metabolic (15%) and ophthalmic disorders (12%). It is also worth highlighting that adenovirus vectors are presently the preferred vehicles used for the delivery of anticancer gene therapies.

Over 60% of gene therapy developers are based in North AmericaOf the 110 companies developing gene therapies in the abovementioned region, 64 are start-ups, 26 are mid-sized players, while 18 are large and very large companies. Further, within this region, most of the developers are based in the US, which has emerged as a key R&D hub for advanced therapeutic products.

More than 31,000 patents have been filed / published related to gene therapies, since 2016Of these, 17% of patent applications / patents were related to gene editing therapies, while the remaining were associated with gene therapies. Leading assignees, in terms of the size of intellectual property portfolio, include (industry players) Genentech, GSK, Sangamo Therapeutics, Bayer and Novartis, (non-industry players) University of California, Massachusetts Institute of Technology, Harvard College, Stanford University and University of Pennsylvania.

USD 16.5 billion has been invested by both private and public investors, since 2014Around USD 3.3 billion was raised through venture capital financing, representing 20% of the total capital raised by industry players till June 2019. Further, there have been 28 IPOs, accounting for more than USD 2.2 billion in financing of gene therapy related initiatives. These companies have also raised significant capital in secondary offerings.

30+ mergers / acquisitions have been established between 2014 and 2019Examples of high value acquisitions reported in recent past include the acquisition of AveXis by Novartis (2018, USD 8,700 million) and Bioverativ by Sanofi (2018, USD 11,600 million).

North America and Europe are anticipated to capture over 85% of market share by 2030With a promising development pipeline and encouraging clinical results, the market is anticipated to witness an annualized growth rate of over 40% during the next decade. In addition to North America and Europe, the market in China / broader Asia Pacific region is also anticipated to grow at a relatively faster rate.

To request a sample copy / brochure of this report, please visit this link

Key Questions Answered

The USD 10 billion (by 2030) financial opportunity within the gene therapy market has been analyzed across the following segments:

The report features inputs from eminent industry stakeholders, according to whom gene therapies are likely to be the most promising treatment options for genetic disorders. The report includes detailed transcripts of discussions held with the following experts:

The research covers brief profiles, featuring an overview of the therapy, current development status and clinical results. Each profile includes information on therapeutic indication, targeted gene, route of administration, special designations, mechanism of action, dosage, patent portfolio, technology portfolio, clinical trials and recent developments (if available).

For additional details, please visit https://www.rootsanalysis.com/reports/view_document/gene-therapy-market-3rd-edition-2019-2030/268.html

or email [emailprotected]

Contact:Gaurav Chaudhary+1 (415) 800 3415+44 (122) 391 1091[emailprotected]

See the original post here:
Gene Therapy Market is projected to be worth USD 10 Billion by 2030 - The Daily Chronicle

Recommendation and review posted by Bethany Smith

Axovant Gene Therapies (AXGT) is a gene therapy company focused on treating neurodegenerative diseases, including Parkinson's Disease. Despite being in early clinical stages and being relatively underfunded, in my opinion, at today's valuation, it offers a very interesting risk/reward proposition. I explain why in this article.

(source)

AXGT's premier drug under development is AXO-Lenti-PD aimed at treating Parkinson's Disease. The drug is a re-engineered version of an earlier gene therapy developed by Oxford BioMedica (OTCPK:OXBDF) under the name "ProSavin". The re-engineered version is thought to improve gene payload and delivery, but because the same genes are being delivered, the data from ProSavin will also be included in any eventual FDA submission.

As Parkinson.org reminds us, "Parkinsons disease (PD) is an extremely diverse disorder. While no two people experience Parkinsons the same way, there are some commonalities. PD affects about one million people in the United States and ten million worldwide. The main finding in brains of people with PD is loss of dopaminergic neurons in the area of the brain known as the substantia nigra."

AXO-Lenti-PD's mechanism of action is to deliver three genes (TH, CH1 and AADC) involved in converting tyrosine and levodopa into dopamine. By increasing dopamine in the brain, AXGT hopes to reverse the symptoms of Parkinson's in its patients.

(source)

(As an aside, the only direct gene therapy competition in the space that I'm aware of is a collaboration between Neurocrine Biosciences (NBIX) and Voyager (VYGR) whose treatment delivers only one of the three genes (AADC) to its patients.)

AXGT is using the Unified Parkinson's disease rating scale (UPDRS) motor score (subscale III) to assess improvements in Parkinson's symptoms. This is the most commonly accepted measure for the disease and to gage the effectiveness of treatments.

One JAMA meta study attempted to equate changes in UPDRS scores into levels of clinically important differences (CIDs). The results were as follows:

Concordance among multiple approaches of analysis based on subjective and objective data show that reasonable estimates for the CID on the UPDRS motor score are 2.5 points for minimal, 5.2 for moderate, and 10.8 for large CIDs.

The JAMA study is helpful in assessing AXGT's early results.

AXGT treated 15 patients at three dose levels in the initial ProSavin trial. The data showed dose dependence and the overall improvements in UPDRS-III scores would have ranked the two higher dose groups as having "large" clinically important differences according to the JAMA researchers.

Six patients have been treated with AXO-Lenti-PD at two dose levels, with results having been attained for the first two treated at the lower dose and partial results for one patient in the higher dose group.

(source)

The initial results are an improvement over the original ProSavin data and overall the potential for this treatment is tantalizing, given the expected deterioration of patients on today's standard of care (levodopa). Compare the timeline of AXGT's treatment results to an older graph showing the 40 week data for levodopa (note that the second graph is total score, not subsection III as I wasn't able to find exactly comparable data). For a deeper dive, see this NCBI paper titled "Progression of motor and nonmotor features of Parkinson's disease and their response to treatment".

(source)

Changes in Total Scores on the Unified Parkinson's Disease Rating Scale (UPDRS) from Baseline through Evaluation at Week 42.

The changes in subjects treated with levodopa at different doses or with placebo were determined on the basis of the total scores on the UPDRS. (source)

The initial market for AXGT's gene therapy is on the order of 100K patients. Given that it's a one time treatment, charging $75K to $100K wouldn't be unreasonable. That's a market opportunity of $7.5B to $10.0B should everything work out.

(source)

However Oxford BioMedica didn't exactly give the technology away, such that the licensing agreement allows Oxford to materially participate in any future success AXGT may have with this gene therapy. From the most recent 10Q (with my emphasis):

In June 2018, we, through our wholly owned subsidiary, ASG, entered into the Oxford Agreement, pursuant to which we received a worldwide, exclusive, royalty-bearing, sub-licensable license under certain patents and other intellectual property controlled by Oxford to develop and commercialize AXO-Lenti-PD and related gene therapy products for all diseases and conditions. In June 2018, as partial consideration for the license, we made an upfront payment to Oxford of $30.0 million, $5.0 million of which was applied as a credit against the process development work and clinical supply that Oxford is obligated to provide to us over the term of the Oxford Agreement. Under the terms of the Oxford Agreement, we could be obligated to make payments to Oxford totaling up to $55.0 million upon the achievement of specified development milestones and $757.5 million upon the achievement of specified regulatory and sales milestones. In April 2019, certain development milestones were achieved resulting in a $13.0 million net payment due to Oxford. We will also be obligated to pay Oxford a tiered royalty from 7% to 10%, based on yearly aggregate net sales of the underlying gene therapy products, subject to specified reductions upon the occurrence of certain events as set forth in the Oxford Agreement. These royalties are required to be paid, on a product-by-product and country-by-country basis, until the latest to occur of the expiration of the last to expire valid claim of a licensed patent covering such product in such country, the expiration of regulatory exclusivity for such product in such country, or 10 years after the first commercial sale of such product in such country.

Personally I think that these high costs validate the potential of the treatment, but they of course also limit the benefit AXGT will see from it successful deployment.

Before looking at the company's valuation and the risk/reward it presents, let's quickly look at the company's other two product candidates which are aimed at treating rare neurological diseases.

This gene therapy is intended to treat Gangliosidosis, a very rare but fatal pediatric disease for which there is currently no treatment. Initial 6 month data from the Stage 1 low dose cohort is expected some time next quarter.

(source)

This gene therapy is a dual vector program aimed at delivering HEXA and HEXB genes into patients with GM2 gangliosidosis (including Tay-Sachs disease and Sandhoff disease).

(source)

There is initial data from two patients, with the second one showing some promise. From the most recent 10Q:

Patient #2

In June 2019, a six month old child with early symptomatic infantile Tay-Sachs disease received AXO-AAV-GM2 prior to the onset of severe symptoms, delivered into the thalamus bilaterally as well as into the cisterna magna and lumbar intrathecal space, the planned routes of administration for patients in the registrational program. The surgical procedure was well tolerated with no neurological defects noted. There were baseline elevated transaminases noted with a transient increase. This child is clinically stable at six months after dosing with plateaued development. Importantly, no seizure activity and no exaggerated startle responses were observed. By contrast, the patients untreated, two older siblings with Tay-Sachs disease exhibited rapid disease progression, clinical regression and seizure onset at 12 to 18 months of age. In addition, brain MRIs taken three and six months after administration (at 10 and 13 months of age, respectively) demonstrated no damage to the thalamus and normal new myelin deposition. By contrast, commonly reported MRI findings in infantile Tay-Sachs disease at this age include demyelination and cerebral and cerebellar atrophy. The CHOP INTEND score, a 16-item scale of motor function that has been validated in infants with neuromuscular disorders, was 58 out of 64 at baseline, increasing to a total score of 60 at month three following gene transfer and declining to a total score of approximately 52 at month 12 following gene transfer. Total CHOP INTEND scores sustained at levels greater than 40 points indicate a clinically meaningful improvement.

With the stock trading at $4.72, AXGT sports a market cap of $198M and an EV of $143M thanks to the $55M it had as cash on the balance sheet at the end of June.

(source)

For a company with a multi-billion dollar opportunity in front of it, these seem to be low valuations.

The risk however is continued dilution and/or failed or stalled trials which would mean that the company either doesn't succeed or the share count is much higher by the time the company is generating revenues. Indeed, despite having $55M in cash on the balance sheet, the company is operating under a going concern warning.

From the 10Q with my emphasis:

As of June 30, 2020, the Companys cash and cash equivalents totaled $55.5 million and its accumulated deficit was $767.2 million. For the three months ended June 30, 2020 and the fiscal year ended March 31, 2020, the Company incurred net losses of $8.6 million and $72.6 million, respectively. The Company expects to continue to incur significant operating and net losses, as well as negative cash flows from operations, for the foreseeable future as it continues to develop its gene therapy product candidates and prepares for potential future regulatory approvals and commercialization of its products, if approved. The Company has not generated any revenue to date and does not expect to generate product revenue unless and until it successfully completes development and obtains regulatory approval for at least one of its product candidates, and its current cash and cash equivalents balance will not be sufficient to complete all necessary development activities and commercially launch its products. The Company anticipates that its current cash and cash equivalents balance will not be sufficient to sustain operations beyond nine months following the date that these unaudited condensed consolidated financial statements and notes were issued, which raises substantial doubt about the Company's ability to continue as a going concern.

The company also has an ATM in force, from the 10Q:

During the three months ended June 30, 2020, the Company engaged SVB Leerink LLC as its agent to sell the Company's common shares from time to time through an at-the-market equity offering program. SVB Leerink LLC receives compensation for its services in an amount equal to 3% of the gross proceeds of any of the Company's common shares sold. As of June 30, 2020, the Company sold approximately 1.4 million common shares for total proceeds of approximately $4.3 million, net of brokerage fees, under this program, and subsequent to June 30, 2020, the Company has sold approximately 1.1 million common shares for total proceeds of approximately $3.3 million, net of brokerage fees (see Note 12).

AXGT has a promising gene therapy for Parkinson's Disease which will have more safety and efficacy data released next quarter. Should the data continue to substantially improve on current standard of care, I think investors will begin to take into account the huge potential market opportunity and the stock will rise impressively despite the risks mentioned above. With this in mind, I may take a starter position in the near future, but in doing this research I've also become intrigued by the idea of using OXBDF as a way to participate without taking the full risks that AXGT engenders. I will write up my findings if I do decide to go that way.

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Disclosure: I/we have no positions in any stocks mentioned, but may initiate a long position in AXGT over the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

Additional disclosure: I actively trade around core positions.

Originally posted here:
Axovant Offers An Interesting Risk-Reward Proposition - Seeking Alpha

Recommendation and review posted by Bethany Smith

Manipal Academy of Higher Education (MAHE) in India and Esco Aster in Singapore have signed agreement to establish collaborative research unit at MAHE, Manipal

This is the second Esco Aster collaborative research unit set up globally after the firstCentre of Excellence (COE) with Bioprocessing Technology Institute (BTI), Singapore. Esco Aster hopes to continue to develop more collaborations in Asia Pacific in years to come to work on the booming cell and gene therapy.

As per the agreement, ESCO Aster and MAHE will jointly establish a research unit at MAHE Manipal campus to carry outactivities related to development and manufacturing in the biotherapeutics area.MAHE will provide cGMP compliant facility and necessary resources for carrying out the research activities.

-Lt. General Dr. Venkatesh M.D., MAHEs Vice Chancellor

Weare excited to sign this agreement with MAHE and we look forward for harnessing the skilled manpower and mentor pool available at MAHE to build our pipeline products and services to our clients. We envision showcasing this research unit to our potential clients and collaborators and also utilizing it as a training centre.

-Xiangliang Lin, Esco Aster Chief Executive Officer

Through this agreement, both parties aim to facilitate research, development, and commercial plans and activities relating to stem cells or extracellular vesicles. Other fields of study with potential advantages to scientific discoveries are also welcome. This collaboration opens up potential breakthrough discoveries aiming to drive the biotherapeutics industry.

More here:
Singapore inks research collaboration with India for biotherapeutics - BSA bureau

Recommendation and review posted by Bethany Smith

LONDON, Sept. 24, 2020 (GLOBE NEWSWIRE) -- (Companies Included: Crispr Therapeutics, Thermo Fisher Scientific, Intellia Therapeutics, Horizon Discovery, and Synthego Corporation)

In another instance, in early May, the US Food and Drug Administration (FDA) granted Sherlock Biosciences an emergency use authorization (EUA) for its COVID-19 diagnostic assay, beating out other companies and academic groups trying to use the powerful gene-editing technology to figure out who is infected with the novel coronavirus. Sherlocks test is the first FDA-authorized use of CRISPR technology for anything. Sherlocks test is a molecular diagnostic, intended to identify people who have acute SARS-CoV-2 infection. It capitalizes on a CRISPR-based technology developed in the lab of Feng Zhang, a scientist at Broad Institute of MIT and Harvard and a cofounder of Sherlock.

The Business Research Companys report titled CRISPR Technology Global Market Report 2020-30: Covid 19 Growth And Change covers the CRISPR market 2020, CRISPR technology market share by company, global CRISPR technology market analysis, global CRISPR technology market size, and CRISPR technology market forecasts. The report also covers the global CRISPR technology market and its segments. The CRISPR technology market share is segmented by product type into Cas9 and gRNA, design tool, plasmid and vector, and other delivery system products. The CRISPR technology market share is segmented by end-user into biopharmaceutical companies, agricultural biotechnology companies, academic research organizations, and contract research organizations (CROs). By application, it is segmented into biomedical, agriculture, diagnostics, and others.

Request A Sample Of The Global CRISPR Technology Market Report:

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The global CRISPR technology market value is expected to grow from $685.5 million in 2019 to $1,654.2 million in 2023 at a compound annual growth rate (CAGR) of 24.6%. The application of CRISPR technology as a diagnostic tool is expected to boost CRISPR technology market growth during the period. The Sherlock CRISPR SARS-CoV-2 kit is the first diagnostic kit based on CRISPR technology for infectious diseases caused due to COVID-19. In May 2020, the US FDA (Food and Drug Administration) announced emergency use authorization of Sherlock BioSciences Inc.s Sherlock CRISPR SARS-CoV-2 kit, which is a CRISPR-based SHERLOCK (Specific High-sensitivity Enzymatic Reporter unLOCKing) diagnostic test.

This test helps in specifically targeting RNA or DNA sequences of the SARS-CoV-2 virus from specimens or samples such as nasal swabs from the upper respiratory tract, and fluid in the lungs from bronchoalveolar lavage specimens. This diagnostic kit has high specificity and sensitivity, and does not provide false negative or positive results. Widening the application of CRISPR technology for the diagnosis of infectious diseases will further increase the demand for CRISPR technology products and services and drive the CRISPR market 2020.

Several advancements in CRISPR technology are trending in the market. Advancements in technology will help in reducing errors, limiting unintended effects, improving the accuracy of the tool, widening its applications, developing gene therapies, and more. Scientists, researchers and companies are increasingly developing advanced CRISPR technologies for more precise editing and to get access to difficult to reach areas of human genome. For instance, in March 2020, scientists at University of Toronto developed CHyMErA, a CRISPR-based tool for more versatile genome editing. Similarly, in March 2020, researchers at New York genome center developed a new CRISPR screening technology to target RNA, including RNA of novel viruses like COVID.

In November 2019, researchers at ETH Zurich, Switzerland, swapped CAS9 enzyme for Cas 12a, that allowed the researchers to edit genes in 25 target sites. It is also estimated that hundreds of target sites can be modified using the above method. In October 2019, a team from MIT and Harvard developed new CRISPR genome editing approach called prime editing by combining CRISPR-Cas9 and reverse transcriptase into a single protein. The prime editing has the potential to directly edit human cells with high precision and efficiency.

The CRISPR technology market share consists of sales of CRISPR technology products and services, which is a gene-editing technology that allows researchers to alter DNA sequences and modify gene function. The revenue generated by the market includes the sales of products such as design tools, plasmid & vector, Cas9 & gRNA, and libraries & delivery system products and services that include design & vector construction, screening and cell line engineering. These products and services are used in genome editing/genetic engineering, genetically modifying organisms, agricultural biotechnology and others, which include gRNA database/gene library, CRISPR plasmid, and human stem cell & cell line engineering.

CRISPR Technology Global Market Report 2020-30: Covid 19 Growth And Change is one of a series of new reports from The Business Research Company that provide market overviews, analyze and forecast market size and growth for the whole market, CRISPR technology market segments and geographies, CRISPR technology market trends, CRISPR technology market drivers, CRISPR technology marketrestraints, CRISPR technology market leading competitors revenues, profiles and market shares in over 1,000 industry reports, covering over 2,500 market segments and 60 geographies. The report also gives in-depth analysis of the impact of COVID-19 on the market. The reports draw on 150,000 datasets, extensive secondary research, and exclusive insights from interviews with industry leaders. A highly experienced and expert team of analysts and modellers provides market analysis and forecasts. The reports identify top countries and segments for opportunities and strategies based on market trends and leading competitors approaches.

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The Global CRISPR Technology Market Size Is Seeing Exponential Growth Due To The Application Of CRISPR Technology In Treating COVID-19 - GlobeNewswire

Recommendation and review posted by Bethany Smith

IRVINE, Calif.--(BUSINESS WIRE)--Applied Biology in collaboration with researchers at University Hospital Ramon y Cajal in Madrid, Spain, today announced results from their androgen receptor genetics study in hospitalized COVID-19 male patients (NCT04368897, https://clinicaltrials.gov/ct2/show/NCT04368897?term=androgen&cond=Covid19&draw=2&rank=4). The aim of the study was to confirm a direct association between androgens and COVID-19, potentially paving the way for a breakthrough therapy against SARS-CoV-2.

This prospective longitudinal study analyzed the length of a variable genetic repeat in the androgen receptor gene of hospitalized COVID-19 male patients. The results of the clinical study were published in the Journal of the European Academy of Dermatology and Venerology (doi: 10.1111/jdv.16956).

The study demonstrated that the proportion of male patients admitted to the ICU with the longer variant was statistically significantly higher compared to males with the shorter variant. Similarly, the risk of ICU admissions was significantly higher among males with the longer variant (OR 2.9143). In addition, COVID-19 patients with the shorter variant experienced a shorter duration of hospitalization compared to males with the longer variant (25 days vs 47.5 days). Overall, the longer variant of the androgen receptor was associated with higher disease severity among hospitalized male COVID-19 patients.

The team was led by Andy Goren, MD, Medical Researcher and Co-Investigator with the Department of Dermatology at the University Hospital Ramon y Cajal in Madrid, Spain; Sergio Va Galvn, MD, from the Department of Dermatology at the University Hospital Ramon y Cajal; Sabina Herrera, MD, from the Infectious Disease Department at the University Hospital Ramon y Cajal; Carlos G. Wambier, MD, PhD, from the Department of Dermatology at the Alpert Medical School of Brown University; and Flavio A. Cadegiani, MD, MSc, PhD, from Corpometria Institute in Brazil.

According to Dr. Sergio Va Galvn: To the best of our knowledge, this is the first study to directly confirm an association between androgens and COVID-19 disease severity.

According to Dr. Carlos Wambier: This is another piece of the puzzle for the scientific understanding of role of androgens in the pandemic.

Further, according to Dr. Andy Goren: The results of this study further support our research into the use of anti-androgens in the treatment of COVID-19. If randomized prospective trials demonstrate efficacy, anti-androgens may provide a breakthrough inexpensive treatment for COVID-19.

ABOUT APPLIED BIOLOGY

Founded in 2002, Applied Biology, Inc. (www.appliedbiology.com), headquartered in Irvine, California, is a biotechnology company specializing in hair and skin science. Applied Biology develops breakthrough drugs and medical devices for the treatment of androgen mediated dermatological conditions. Applied Biology's R&D pipeline includes a topically applied prophylactic treatment for chemotherapy induced alopecia; a novel diagnostic device that can aid dermatologists in identifying non-responders to topical minoxidil; an adjuvant therapy for non-responders to topical minoxidil; and a novel therapy for female pattern hair loss.

Go here to read the rest:
Applied Biology in Collaboration with Researchers at University Hospital Ramon y Cajal Hospital Announce Results from Study of Androgen Receptor...

Recommendation and review posted by Bethany Smith

Gene Therapy

A report by The Insight Partners on the Global Gene Therapy Market discusses the growth of the market in great detail. It discusses thoroughly all factors promoting and deterring the market. The report also focuses on the competitive dynamics in the market by monitoring the strengths and weaknesses of prominent contributors and their key products.

Gene Therapy provide the ability for remote medical diagnosis and remote medical care in the home, which is particularly important for the growing ageing society, which may require assisted living. Satellite connectivity can also assist in the gathering of data to predict and track disease progression and associated risks of outbreaks.

Request for sample PDF Copy @ https://www.theinsightpartners.com/sample/TIPHE100001165/

Top leading companies operating in the global Gene Therapy market:-

Sangamo Therapeutics, Inc., bluebird bio, Inc., uniQure N.V., AveXis, Inc., Vineti, Solid Biosciences., Spark Therapeutics, Inc., CHIMERON BIO, RENOVA THERAPEUTICS, HORAMA S.A.

Valuable Data included in the report:

Our expert team is consistently working on updated data and information of key players related business processes which values the market. For future strategies and predictions, we provide special section regarding covid-19 situation.

Due to the pandemic, we have included a special section on the Impact of COVID 19 on the Gene Therapy Market which would mention How the Covid-19 is Affecting the Disposable Incontinence Products (DIPs) Industry, Market Trends and Potential Opportunities in the COVID-19 Landscape, Covid-19 Impact on Key Regions and Proposal for Disposable Incontinence Products (DIPs) Players to fight Covid-19 Impact.

Important Queries Addressed in the report:

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Gene Therapy Market 2020 Demand Analysis, Economic Stability and Investment Opportunity For Expansion 2027 - Crypto Daily

Recommendation and review posted by Bethany Smith

The research report, titled [Global Hemophilia Gene Therapy market 2020 by Manufacturers, Type and Application, Forecast to 2025], presents a detailed analysis of the drivers and restraints impacting the overall market. Analysts have studied the key trends defining the trajectory of the market. The research report also includes an assessment of the achievements made by the players in the global Hemophilia Gene Therapy market so far. It also notes the key trends in the market that are likely to be lucrative. The research report aims to provide an unbiased and a comprehensive outlook of the global Hemophilia Gene Therapy market to the readers.

The Hemophilia Gene Therapy market report offers a comprehensive analysis of this industry vertical, emphasizing on the key growth stimulants, opportunities, and constraints projected to shape the market dynamics over the forecast period.

As per industry experts, the market is anticipated to grow significantly, registering a CAGR of XX% over the analysis period of 2020-2025

Request Sample Copy of this Report @ https://www.express-journal.com/request-sample/207769

Instabilities in the supply & demand channels due to the stringent lockdown measures imposed to address the COVID-19 pandemic has left numerous companies in disarray. Speaking of the ambiguity of revenues in the near term, businesses are expected to face hindrance even once the economy recovers from the pandemic.

Additionally, the report offers a holistic assessment of various industry segments to infer the revenue projections for the market over the study duration.

Key inclusions of the Hemophilia Gene Therapy market report:

Hemophilia Gene Therapy Market segments covered in the report:

Regional analysis: North America, Europe, Asia-Pacific, South America and Middle East and Africa

Product spectrum: Hemophilia A and Hemophilia B

Applications spectrum: Hemophilia A Gene Therapy and Hemophilia B Gene Therapy

Competitive landscape:

Information including major players operating in the market along with the manufacturing facilities as well as competitors of each participant

Questions Answered by the Report:

What will be the size of the global Hemophilia Gene Therapy market in 2025?

What is the current CAGR of the global Hemophilia Gene Therapy market?

Which product is expected to show the highest market growth?

Which application is projected to gain a lions share of the global Hemophilia Gene Therapy market?

Which region is foretold to create the most number of opportunities in the global Hemophilia Gene Therapy market?

Will there be any changes in market competition during the forecast period?

Which are the top players currently operating in the global Hemophilia Gene Therapy market?

How will the market situation change in the coming years?

What are the common business tactics adopted by players?

What is the growth outlook of the global Hemophilia Gene Therapy market?

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Hemophilia Gene Therapy Market Overview, Environmental Analysis and Forecast to 2025 - Express Journal

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Monoclonal antibodies that stop the coronavirus from spreading in the body are among promising strategies for averting severe illness from Covid-19 before vaccines arrive, said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.Antibody-based medications, other blood products from recovered patients and antivirals are being investigated as early treatments, Fauci said. The aim is to prevent patients from developing the serious lung damage for which Gilead Sciences Inc.s remdesivir and the anti-inflammatory drug dexamethasone are administered.We are focusing very heavily now on treatment of early infection and, or prevention of infection, Fauci told the Journal of the American Medical Association in an interview Friday. And thats the bridge to the vaccine.Immunization against SARS-CoV-2 could begin in the U.S. in November or December, Fauci said, though it will probably take until at least the third quarter of 2021 for enough Americans to have been protected against the pandemic virus to significantly diminish its threat. Fauci said 100 million doses of vaccine may be produced by December, with all six companies supplying the U.S. slated to have made 700 million doses by next April.

With no vaccines yet proven to prevent Covid-19, health authorities must continue to push for new treatments and measures to stop the coronavirus from spreading, said Robert Chip Schooley, a professor of medicine at the University of California, San Diego, who is studying more potent versions of an existing antiviral.

Optimally, wed have an oral antiviral drug you can give to more people earlier in the course of the illness, Schooley said. Vaccines might not be 100% effective, which is better than nothing, but were still going to have to rely on drugs and behavioral modifications for a long time to come.

Blockbuster studies published by the journal Science on Thursday showed about 14% of critical Covid-19 patients have impaired levels of a substance called interferon that helps orchestrate the bodys defense against viral pathogens.

Read More: Covid Doctors Find a Turning Point in Life-Threatening Cases

The finding opens up new strategies for identifying high-risk patients and treating them with interferon infusions or, in some cases, removing interferon-blocking antibodies from their blood in a procedure called plasmapheresis.

Interferon, which is already being studied in dozens of clinical trials, might improve the effectiveness of antiviral drugs if they are administered early in an infection, according to Stanley Perlman, a professor of microbiology and immunology at the University of Iowa in Iowa City, who has studied coronaviruses for 38 years.

Infusions of coronavirus-neutralizing antibodies may also reduce the amount of virus in patients early in an infection, preventing an immune overreaction thats behind most life-threatening cases, said Thomas File, an infectious diseases physician in Akron, Ohio, and president of the Infectious Diseases Society of America.

Monoclonal antibodies, a product made by cloning an antibody captured from the blood of a patient who recovered from Covid-19, could also be given to high-risk patients in nursing homes as a preventative treatment, Fauci said. Ely Lilly & Co.s experimental antibody LY-CoV555 showed some hopeful signs in a trial among out-patients, the company said on Sept. 16.

"What I do is like military intelligence."

We have some cautious optimism that monoclonal antibodies may be an important therapeutic for early disease, Fauci said Sept. 10 in an online briefing for Massachusetts General Hospital staff. We need something to keep people out of the hospital.

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Early Covid treatments could be a bridge to vaccine - Times of India

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There's nothing more satisfying than downing a glass of cool water when your throat is seemingly on fire. But if you find yourself unable to quench that urgent sense of thirst whether you've worked your way through eight or eighteen cups of water in a given day there may be a larger issue at hand. Feeling super thirsty is totally normal if you've just powered your way through a long workout, have spent the day outside under a hot sun, or are working on upkeep around the house (dehydration can manifest itself in cramps or fatigue as well). But endless thirst isn't something that anyone should be living with in the long run.

Many people sip on water throughout the day, thinking they're sufficiently hydrated; but for the majority, the simplest explanation for feeling thirsty is just that they're not drinking enough. "You want to aim for half of your body weight in ounces of water each day," says Stefani Sassos, MS, RD, CDN, the Good Housekeeping Institute's registered dietitian, highlighting a rule of thumb that most can stick to. "If you weigh 160 pounds, as an example, you'll want to aim for about 80oz based on that math just about 10 cups of water a day. Get from ounces to cups by simply dividing by eight, since 8oz is one cup."

If you find that your water intake is close or even above that recommended benchmark, it's time to consider other factors that have you reaching for your water bottle. Believe it or not, it's a condition all its own: polydipsia. "It's an excessive amount of not only thirst but drinking, and it indicates a pathology, which is much different than dehydration," says Ron Weiss, M.D., a board-certified internist and assistant professor of clinical medicine at Rutgers' New Jersey Medical School. Your diet may play a role in potentially developing polydipsia or related symptoms, certainly, as can other lifestyle factors; sometimes, thirst may be an indicator of a larger issue that requires a doctor's help. Below, we review nine more common reasons for constantly feeling thirsty, plus expert tips to finally help you quench that thirst.

Reminder: Consult your physician right away if you're experiencing excessive thirst as it could be a signal for an underlying condition.

Let us explain: If you normally have had plenty to drink throughout your routine, but that routine has adapted in some way recently, it may require you to increase the amount of water you consume in a given day. Most often, people don't account for weather changes, new exercise routines, or a change in career and new daily physicality into upping their water intake. In hotter climates where you may sweat more, or if you've recently started playing a new sport or joined a new club, it's crucial to drink more throughout the day, Sassos explains especially for seniors and the elderly.

You may want to reevaluate your water intake if you are experiencing these symptoms regularly:

Especially one that's angled for dramatic weight loss. "In general, low-carb or keto diets put you at greater risk for dehydration. Carbohydrates retain fluids and electrolytes, so when you drastically decrease the amount of carbs in your diet, that results in extra water being removed through your urine or more trips to the bathroom," says Sassos, who has previously declared keto diets as one of the worst diets for many more reasons.

If you're new to a diet where you're drastically reducing or eliminating a food group entirely, it's important to remain focused on how much water you drink every day, because of that risk of low-carb diets leading to dehydration (and if left unchecked, kidney stones or constipation). "The most important thing, regardless of your diet, is to drink according to your thirst and listen to your body," Sassos adds. "You can also look at your urine to gauge your hydration; you want to see a light lemonade or pale straw-type color, which indicates you are properly hydrated."

It's also important to take a closer look at the food you're already eating. Just like your body processes excess glucose, your kidney processes excess salt and redirects it into your urine, which in turns pulls liquids away from your blood. "And then you would pee an excessive amount," Dr. Weiss says, adding that this process can happen in as little as a few hours if you've eaten a high-sodium meal. "Then, your brain would make you feel thirsty, to take back free water."

While it's natural (and good!) to drink lots of water after enjoying a salty meal, if you're frequently eating meals that are overly high in sodium, chronic dehydration may not be the only condition you could battle later on. Overdoing it on sodium can lead to high-blood pressure over time, and may also lead to kidney or heart damage in the long run. The American Heart Association recommends that Americans eat less than 1,500mg of sodium each day, so if you already know you may be doubling or tripling that limit, talking to your primary care provider about a low-sodium diet is a good idea.

Think salt might be the culprit, but aren't sure? Sassos advises doubling down on fruits and vegetables for a couple weeks to see if your frequent thirst disappears. "Fruits and vegetables naturally have a ton of water content and can help you reach your hydration goal without having to down an extra bottle," she says. "Watermelon, celery, and cucumbers are some of my favorites, and all are over 90% water."

We're sure that you've heard that hunger can sometimes be mistaken for thirst, but did you know that the opposite is also true? "Many symptoms of dehydration, like fatigue and dizziness, can feel similar to feelings of hunger," Sassos says. "It's very important to listen to your body and get in touch with your hunger and thirst cues."

If you've downed a few glasses of water and can't get rid of the feeling that you should be drinking more, it might be time to reach for a snack or think about lunch or dinner. "But if you just had a balanced meal or snack reach for a glass of water [first] to see if hydration is what you really need."

It may be due to new medication or because of high-blood pressure (or a myriad of other health reasons), but dry mouth can also be mistaken for thirst. Dr. Weiss points out that caffeine intake, smoking, and over-the-counter antihistamines or cold medicine can aggravate a case of dry mouth. But medical experts at the Mayo Clinic say that those suffering from dry mouth can get some relief by chewing sugar-free gum to stimulate saliva, in addition to sipping water as frequently as possible. There are medications that can help relieve dry mouth if neither of these solutions work.

When it comes to Dr. Weiss's patients, he says that those who have complained of excessive, constant thirst often end up having complications related to diabetes. Mostly, type 2 diabetes, otherwise known as diabetes mellitus in the medical community, as the kidneys are under more stress to absorb excess glucose, Dr. Weiss explains. When the kidney can't keep up, the glucose ends up in your urine, dragging water along with it, making you feel awfully dehydrated. It can happen quite regularly if your diabetes is undiagnosed or undetected.

Diuretic foods (like celery or asparagus) or drinks can work to make you thirsty over time because they encourage more urination than usual. "Diuretics force sodium to be eliminated by your kidneys it's the laws of osmosis, so you lose water in the process, and then your brain signals that you need more water," Dr. Weiss explains. When it comes to diuretic supplements, he says, "It's the physician's job to make sure the patient isn't getting too much diuretic It'd be drying them out, making them thirsty, if they were being overmedicated with diuretics."

Sassos explains that caffeinated beverages are known to be mildly diuretic, and if you are drinking too much coffee or soda over the course of the day, it may trigger innate thirst. "I recommend no more than 400mg of caffeine daily for healthy adults, or less, if you're sensitive to caffeine like I am," she says. Alcohol is also a diuretic and can be equally harmful for your body, especially if you already aren't getting enough water during the day.

Yulia ReznikovGetty Images

Sometimes, you can be drinking TOO much water yes, really! "Overhydration is a real issue, though less common because normal healthy kidneys easily excrete excess water," Sassos says. "It's more common a problem for people who have kidney issues and can't excrete urine normally." If you have any chronic condition that affects your kidney, your doctor may have already spoken to you about adapting your hydration and beverages you should avoid (and if you haven't had that discussion yet, it's time!).

Kidneys aren't the only organ that can influence your thirst and water regulation in your body. Dr. Weiss points out that your thyroid (which also can influence your appetite, temperature, and even your hair) can greatly impact how thirsty you feel if the gland's hormone production is impacted. Hyperthyroidism and other thyroid issues can contribute to period irregularity and anxiety, among other things, all of which influences thirst. The National Institutes of Diabetes and Digestive and Kidney Diseases also report that those with thyroid issues may also be more likely to suffer from type-1 diabetes, anemia, and other conditions, which may be the root cause of raging thirst.

It's much more rare than having issues related to type 2 diabetes, but some individuals may develop a disorder that doctors know as diabetes insipidus, which triggers a sustained imbalance of fluids in your body. "It has to do with an inappropriately high production rate of a hormone called ADH, which stands for antidiuretic hormone, and how it affects your brain overall," Dr. Weiss explains. "What this does is, it forces your kidney to dump water out of your body, beyond what's appropriate; then, this hormone abnormality would force the person to seek water, like with a raging thirst. I've only confirmed it twice in my life, as it's relatively rare."

Those with diabetes insipidus would also be frequently urinating. But you wouldn't be able to confirm the condition unless you discussed the issue and had a full set of blood work done by your provider which hopefully would be in your plans long before you ever were worried about diabetes insipidus.

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Why Am I Always Thirsty? - 9 Health Explanations for Excessive Thirst - GoodHousekeeping.com

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Smart exercise company Echelon has teamed with Amazon for a $500 spin bike that only Prime subscribers can buy.

The Echelon Ex-Prime Smart Connect Bike, unveiled Tuesday, allows users to join virtual exercise classes and connect with personal trainers remotely.

The bike can be bought through Amazon Prime only. Echelon had a similar arrangement with Walmart for its Connect Sport bike, which costs $600, though it had an introductory price of $500.

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Echelon, which has made connected fitness products since 2017, said Amazon initiated the partnership, and the two companies developed the bike together. It's Amazon's first foray into the connected fitness market.

But the delays caused other problems too. When Peloton announced the price cuts, it said it would automatically refund customers who purchased a bike within the last 30 days or are still waiting for back-orders. Customers who narrowly missed the 30-day window or who waited weeks for their back-ordered purchases took to Twitter to express their anger over the policy. Peloton said owners of its original bike can trade it in for a $700 rebate, and free yoga and toning accessories.

Peloton also came under fire after customers told Business Insider they had to wait weeks, and in some cases months, for the fitness company to make repairs to their broken bikes.

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Amazon's first foray into connected fitness is a $500 smart bike made by Echelon that only Prime subscribers c - Business Insider India

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You probably think of staying in good health as something thats insanely time consumingthe stuff of extreme diets, expensive gyms or off-and-on cleanses. But the truth is, there are dozens of easy and effective ways you can seriously improve your health in fifteen minutesor even lessper day. These tiny tweaks, many of which are great fun, can help you strengthen your immune system, boost your mood, and prevent serious diseases like cancer, Alzheimers and Parkinsonsand here, we share them exclusively with you. Read on, and to ensure your health and the health of others, dont miss these Sure Signs Youve Already Had Coronavirus.

1

Add a few minutes to each mealtime.

Eat slowly, says Mackenzie Griffith, a Precision Nutrition certified coach. This will give your body time to send you satiety/fullness cues, making you naturally and voluntarily eat less food. Do this by putting down your utensil between bites, talking to the people around you, chewing more thoroughly, or really focusing on the flavors and textures youre experiencingbecome a sommelier of whatever youre eating. Youll find youre more satisfied, dont feel bloated, and naturally start to shed some weight.

2

Go outside.

An effective way for you to ease stress is by literally changing your view, says Dr. Richard Carmona, former Surgeon General of the U.S. and Chief of Health Innovation at Canyon Ranch. Just sitting quietly outside for a few minutes can help. Nature is easy on the eyes and easy on the ears, and by linking yourself to its calmness, you can lower your anxiety and increase brain health.

3

Doit.

Studies have found that having sex on a regular basis can help lower blood pressure, which can decrease your risk of stroke. According to a study published in American Journal of Cardiology, men who had sex at least twice a week were less likely to develop cardiovascular disease compared with men who had sex once a month. Thats likely because sexual activity increases feel-good chemicals in the brain like dopamine and the bonding hormone oxytocin, which can lower high blood pressure, the No. 1 cause of stroke.

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4

Have exercise snacks.

According to Harvard Medical School, researchers have found that people who exercise for just 15 minutes a day live, on average, three years longer than those who dont. New research is proving that exercise snacks are great ways to decrease negative health outcomes (high cholesterol, blood sugars, etc) found in many chronic diseases, says Kathryn Hossack, BSc. CAT(C), owner of Integrative Movement and RideWell Performance. These include doing short bursts, like 20 to 30 seconds of moderate activity, like walking up a flight of stairs or jumping jacks, once every hour or two in your day. Its perfect for those who work at a desk.

5

Talk to a friend.

Feelings of loneliness and social isolation can increase a persons risk of having a heart attack, according to a study published in the journal Heart. People who reported poor social relationships had a 29 percent higher risk of coronary disease, and a 32 percent higher risk of stroke, than people who have solid friendships. The reason: Researchers believe loneliness increases chronic stress, a risk factor for ticker trouble. So take time to drop in on, call or text friends or family regularly.

6

Drink some coffee.

A study published in the European Journal of Neurology found that people who consumed caffeine had a significantly lower risk of Alzheimers Disease than non-drinkers. Why? Researchers believe that certain compounds in roasted coffee may prevent the build-up of brain plaque believed to cause Alzheimers and dementia.

RELATED: COVID Mistakes You Should Never Make

7

Eat a handful of nuts.

Several studies have shown that eating nuts like almonds, walnuts, peanuts or hazelnuts can lower LDL (bad) blood cholesterol, while raising HDL (good) cholesterol among several other health benefits. Eating a small amount of different nuts during the day can help your health significantly in the long run, says Nikola Djordjevic, MD, of MedAlertHelp.org. Nuts are rich in vitamins such as magnesium, selenium or copper. Plus, they are great antioxidants and can help fight free radicals in blood which can cause cell damage and lead to a variety of diseases.

8

Add leafy greens to your meal.

Most people say a complete meal is healthy fat, fiber and protein, but they always forget the greens, says Jacquie Smith, a certified integrative nutrition coach in New York City. Leafy greens are the best type of superfood to add to every meal. Theyre packed with antioxidants, B vitamins, Vitamin C and K, and fiber, which aid in digestion and prevent inflammation. This ultimately prevents chronic diseases and illnesses, such as cancer and cardiovascular disease.

9

Eat berries.

According to a study conducted at the Harvard School of Public Health (HSPH) the high flavonoid content in berries, apples and oranges help ward off the disease. Study participants who consumed the most flavonoids were 40 percent less likely to develop Parkinsons Disease.

10

Make a gratitude list every morning.

Take time to write down ten things youre grateful for in your life, no matter how small or basic. It could be your health, your morning coffee, the ability to pay the mortgage (or having paid off your mortgage). That simple exercise has been shown to improve mood. Gratitude focuses on the good and positives in life, says Dr. Catherine Jackson, a licensed clinical psychologist and board-certified neurotherapist based in Chicago. Research suggests the brain literally produces more dopamine, a feel-good neurotransmitter, when gratitude is expressed. A grateful mind will allow you to be less stressed and feel more positive emotions. While thinking about what you are grateful for is good for the brain, studies show writing it down has even greater benefits.

11

Have a glass of orange juice.

Thats one of the top ways the Arthritis Foundation says you can help prevent the debilitating joint disease. Studies have shown that consumption of Vitamin C reduces the risk of developing osteoarthritis.

12

Play video games.

Seriously. Per a study published in the journal Neuroscience, adults who played a lot of action video games sharpened their vision by 20 percent. Action video game play changes the way our brains process visual information, said study co-author Daphne Bavelier, professor of brain and cognitive sciences at the University of Rochester. After just 30 hours, players showed a substantial increase in the spatial resolution of their vision, meaning they could see figures like those on an eye chart more clearly, even when other symbols crowded in.

13

Track your meals.

In a March study published in the journal Obesity, researchers found that people who tracked their mealslogging them on paper or online, with an app like Lose Itfor at least 15 minutes a day were the most successful at losing weight.

14

Get 15 minutes of sun.

Fifteen minutes of sunlight can help naturally boost Vitamin D levels, which help with bone health and immune function and can also keep circadian rhythm in sync, says John M. Martinez, MD, a primary care physician in La Mesa, California. I find the 15 minutes of sun helps with patients that suffer with insomnia for that reason.

15

Meditate for 15 minutes.

A 2018 study published in The Journal of Positive Psychology found that just 15 minutes of meditation can have the same positive effect on your mood and well-being as taking one vacation day.

RELATED: Im an Infectious Disease Doctor and Would Never Touch This

16

Breathe deeply.

Few people pay attention to their breathing. However, bringing attention to your breath for at least ten minutes a day can reduce stress and increase relaxation, says Jackson. Slow, deep and consistently control breathing activates the parasympathetic nervous system, reduces the heart rate and relaxes the mind and the muscles. It also triggers your neuron in the brain to calm you down. In a stressful situation, the brain needs that extra oxygen to help it think clearly in order to solve or calmly get through the problem.

17

Eat beans.

Or legumes, if youre nasty. A study published in the journal Clinical Diabetes found that participants who ate slightly less than one cup of legumes every day for 10 weeks saw significantly decreased systolic and mean arterial blood pressure.

18

Take a short walk.

People who have been diagnosed with type 2 diabetes or insulin resistance can lower their blood glucose level after meals by taking a 15-minute walk, says Nancy Woodbury, MA, MS, RD, LD/N, a registered dietitian nutritionist in Boca Raton, Florida. The contraction of the larger leg muscles drives excess glucose from the bloodstream directly into the muscle cells, independently of the action of insulin secreted the pancreas. If your pancreas doesnt produce enough insulin, or your muscle cells are resistant to the action of insulin, exercising can help you reduce your blood glucose. Moreover, physical activity that builds muscle mass will increase your capacity to either use or store the glucose which is produced from metabolizing foods with carbohydrates, so you can eat more of them.

19

Do plantar fascia stretches.

Your plantar fascia is the tissue that supports your arches. If we arent actively stretching them in the morning, we pose the risk of developing an inflammatory condition called plantar fasciitis, says Dr. Benjamin Tehrani, a podiatrist at Kings Point Foot&Ankle Specialists in Los Angeles. A simple lacrosse ball massage on the plantar sole of the feet will do the trick. Lay on your back and place the lacrosse ball on the heel. Slowly move the ball from the heel to the ball of your foot, being sure to push against the ground with your feet and feel the ball stretching into the fascia. This helps break up scar tissue or any muscle the has become fatigued from either walking or standing too often or from simple wear and tear of our feet. This helps remove lactic acid from foot muscles, allowing our feet to become more energized and ready for the day.

20

Practice relaxation techniques.

In a pilot study at the Benson-Henry Institute for Mind Body Medicine at Massachusetts General Hospital and at Beth Israel Deaconess Medical Center in Boston, 48 adults with irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD) participated in a nine-week program focused on stress reduction and other healthy behaviors that included relaxation training to be practiced at home for 15 to 20 minutes each day. They not only felt better they had fewer gastrointestinal symptoms and researchers found marked positive changes in genes involved with their stomach conditions. The relaxation response reduced the expression of a number of genes directly linked to the key inflammatory processes of IBD. While the mechanisms behind IBS are less well-defined, they most likely involve stress response, which also could be improved by relaxation response practice, said study researcher Towia Libermann, Ph.D.

21

Listen to music.

According to a study published in the Journal of Alzheimers Disease, adults with self-observed cognitive impairment who listened to 12 minutes of music every day for 12 weeks showed a decrease in a cellular biomarker of aging in the blood, as well as improvements in memory, mood, sleep, and cognitive function. Other studies have found that listening to music or playing a musical instrument improves memory in healthy people, too.

RELATED: Dr. Fauci Says You Can Catch COVID This Way After All

22

Go for a walk together.

As a personal fitness coach, Ive been prescribing challenging fat-loss workouts for years, but as an aging personal fitness coach Ive also recently discovered the decidedly un-challenging activity of going for a walk with my wife every night, says personal trainer and nutrition adviser Matt Edwards. At first it was just to burn calories, and you burn a ton of calories walking, but then I started noticing these other cool benefits creeping in: With no TV, work, phone or other distractions calling for our attention, my wife and I talk. Its nice. Really nice. Its quality time that you can unashamedly devote to simply being with your romantic partner, and it can bring you closer together.

He adds: No distractions also mean that youre completely present in the moment, and the emotional benefits of mindfulness, a practice which promotes being fully present, are felt immediately.

23

Cook with whole foods.

Thats the recommendation of Dr. Terry Wahls, a clinical professor at the University of Iowa. Use ingredients, not boxed, processed foods. The industrialized foods are filled with sugar, salt, and food additives that interfere with our microbes in our gut. Food additives and emulsifiers that are common in industrialized food increase the risk of developing leaky gut, or increased intestinal permeability. When a person has leaky gut, inflammation goes up along with a higher risk of autoimmunity and chronic disease. I can make a meal in a skillet with fresh or frozen vegetables and meator a vegetarian source of protein for those who dont eat meatin less than 15 minutes. Doing so will have a profound impact on your health and your familys health today and far into the future.

24

Do a short burst of high-intensity exercise.

Exercise becomes increasingly important as we age, says Anthony Kouri, MD, an orthopedic surgeon at the University of Toledo Medical Center. Many people think that the only way to benefit from exercise is to do it for a long period of time. However, research suggests that high-intensity exercise in short bursts can improve bone mineral density. Osteoporosis is due to low bone mineral density and is a serious health concern, especially for women. It is a factor in up to 90% of hip fractures. It is often asymptomatic, but can lead to devastating injuries at an older age when our bodies are most vulnerable.

He continues: Recent research suggests that women who participate between 1-2 minutes of high-intensity weight bearing activity each day have 4% better bone health than women who do less than 1 minute of physical activity. Furthermore, women who did more than 2 minutes of this type of exercise had 6% better bone health. These activities include running, jogging, dancing, stair climbing, and tennis, among many others.

25

Meditate.

While meditation is not a cure-all, it helps to slow brain aging, acts as an antidepressant and helps improve depression and anxiety, says Jackson. It has been found to increase grey matter in the hippocampus, which is important for learning and memory and decreases brain cell volume in the amygdala, an area of the brain responsible for fear and stress and improves attention and concentration.

RELATED: Worst Things For Your HealthAccording to Doctors

26

Stretch.

Stretching for just 15 minutes a day can have benefits such as better bone and joint health, improved balance, better flexibility, and mobility, says Dr. Thanu Jeyapalan, clinical director of the Yorkville Sports Medicine Clinic in Toronto. Stretching a few minutes a day will do wonders for your health in the long run.

27

Write in a journal.

Journaling for 15 minutes, or 3 full hand-written pages, can really help you get whatever is buzzing around in your mind and put it down in a physical entity, says Carla E. Campos of 15 Minutes of Creativity. While itll initially feel like a strenuous exercise, with time, youll start to feel better and better about putting all your thoughts, unscripted, and with no edits, down on paper.

28

Pause before that second helping.

Wait 15 minutes after you initial plate before you go back for more, says Martise Moore, a running coach in Los Angeles. It may be just enough time to make you feel full and forgo the unneeded calories.

29

Pet your dog.

Thats right. According to Harvard Medical School, a large study showed that dog owners had lower cholesterol and triglyceride levels than non-ownersand those differences werent explainable by diet, smoking, or body mass index (BMI)! Scientists arent sure why. They do believe that dogs calming effect can lower blood pressure, reducing your risk of cardiovascular disease. Two paws up.

30

Design a sleep ritual.

It doesnt have to be anything fancy something as simple as soaking in a bath for 15 minutes before bed, spraying lavender oil on your pillowcases before you lie down, or committing to a short full-body stretch before bedtime can help you sleep better, says Amanda L. Dale, a certified personal trainer and sports nutritionist. And better sleep leads to better appetite control, reduced inflammation, a lessened incidence of depression, and a lowered risk of heart attack and stroke. And to get through this pandemic at your healthiest, dont miss these 35 Places Youre Most Likely to Catch COVID.

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Doing This for Just Minutes a Day Can Improve Your Health - KYR News

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A man has been left in excruciating pain in hospital after he was stabbed and attacked with bats by three men who broke into his home in Sheffield.

Scott Sinclair, 46, is in hospital with serious injuries after the attack took place in the early hours of September 17 at his home in Valley Road.

He was stabbed four times in his head, neck and back, has a broken shoulder and ribs and his shin has been left in pieces.

Mr Sinclair said that the pain is 'horrendous' and he won't be able to return to the home that he loves.

After an earlier dispute at around 1am Mr Sinclair said that he woke up at 4.30am to three men attacking him in his home.

He said: "I was woken up to the most horrendous pain. I could see a bright light shining at me and three men standing over me.

"They were hitting me with baseball bats, sticks and at one point even a shovel.

"I was screaming at the pain, at first I actually thought that it was a nightmare and that it wasn't real.

"I think I passed out and I felt a prodding sensation four times and now I know that it was me being stabbed by them.

"They left and I just could not move I was in so much pain.

"I started to scream help me and my neighbours heard and ran around to come and help me.

"They really were amazing, they were talking to me and telling me that I was going to be OK whilst they called for help.

"I was scared stiff and still in bewilderment at what had happened."

As well as the injuries sustained in the attack Mr Sinclair also has a number of disabilities including a damaged vertebra which he sustained in a crash, Fibromyalgia and hypopituitarism which affects his bodies ability to produce vital hormones.

Now he fears he will be left in a wheelchair for at least 18 months due to the severity of his injuries.

Mr Sinclair added: "I can't return home as it's not safe.

"I am absolutely devastated about that and I absolutely loved living there.

"I am going to have to start afresh and move out of Sheffield and it's going to be awful but I have no choice.

"I've not slept since it happened, it has just been horrendous."

South Yorkshire Police have said that they are investigating the attack.

A spokeswoman for the force said: ""An investigation is underway into reports of a burglary and assault on Valley Road in Sheffield.

"It is reported that on Thursday 17 September around 4:30am two offenders broke into a property on Valley Road and assaulted a man.

"The man was taken to hospital by ambulance, his injuries are not believed to be life-threatening.

"Officers attended and conducted a search of the area. Enquiries are on-going to locate those involved in the incident.

"Anyone with information is asked to call 101 quoting incident number 96 of 17 September 2020."

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Man scared to return home after being stabbed and beaten by intruders in the middle of the night - Yorkshire Live

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The last seven months or so have been an interesting time to be alive. Lets face it, its not often that we see our grandparents scratching their heads and saying theyve never seen anything like it. From COVID-19 to politics, 2020 has been one of those years that will be referred to in history lessons for decades, if not centuries, to come. Of course all of that upheaval also comes with a record-breaking amount of personal stress, too, manifesting itself in our bodies in all sorts of ways. For a lot of modern men, that tension is working its way out literally through hair loss.

Its perfectly normal to experience some hair loss. Hair goes through phases just like the rest of us. Without getting too technical, theres a growth phase, a transition phase, and a resting phase. Hair can grow for anywhere from five to seven years, depending on your genetics. That transitional phase, on the other hand, only lasts about ten days. The resting phase (the technical term is telogen) can last as long as three months, but thats the point where slowly but surely the hair starts to loosen and come out. After about three months the whole process starts all over again. Usually.

Those of us with Male Pattern Baldness will lose hair due to genetics. The hair follicle starts to shrink and, after a while, that whole growth process just dies out. (Dont despair, there is hope for that.)

Beyond genetics, though the stress of our current times including the stress on your body if you have actually contracted COVID may also lead to premature hair loss. (Editors note: We truly hope that hair loss is the only thing you have to cope with, should you be ill.) In fact, according to Dr Dayal Mukherjee, MD, at The Aura Clinic London, Psychological factors such as stress, anxiety or any significant traumatic episode, may trigger or exacerbate certain types of hair loss.

Dr. Craig Ziering is a hair restoration specialist with clinics in Newport and Beverly Hills, CA, Las Vegas, and New York City. He refers to this circumstance as telogen effluvium. Sure, it sounds like something sticky from Ghostbusters, but its actually the technical term for hair loss that happens after stress. And these past seven months or so have been all about stress.

The coronavirus itself can cause inflammation, so people who are already hypersensitive may find that its bad for their hair, Ziering tells The Manual. Weve even been seeing patients who arent sick suddenly losing more hair than usual. Men particularly are suffering because they are still, traditionally, seen as the head of the household. If they get even a little sick it can cause emotional stress. How will they provide for their families? Compound that with fluctuations in the stock market. Guys who own small businesses may feel it even more because they feel the stress of providing for their families as well as for their employees.

Ziering goes on to point out that a lot of things can unmask underlying genetic hair loss that a patient might not normally experience until later in life. Men who are treated for cancer, for instance, may lose their hair temporarily, but it will grow back. If there is underlying Male Pattern Baldness, however, that may exacerbate hair loss into a more permanent condition.

Sometimes its as simple as giving the patient a sense of control. Everything else in his life is spiraling beyond his power, now its his hair, too? Its about breaking that cycle., says Ziering.

Sometimes that cycle may be as simple as using hair products that are healthier for your hair and scalp. Buildup from styling products can actually clog hair follicles, accelerating that telegenic effluvium response. Here are some of the best natural styling products weve tried.

Dr. Mukherjees comment sparked British grooming brand No Gunk to launch its lighthearted campaign, Dont Be a Receder Peter, in September. The accompanying video shows a young, healthy-haired man transformed into an aged, bald one from using preparations with harsh chemicals and those that leave residue behind. No Gunk is in favor of natural ingredients like lava clay, shea butter, and argan oil.

Winner of 2020 Grooming Awards, Jack Henrys rockstar product only contains four main ingredients beeswax, coconut oil, bentonite clay, and lavender oil to easily shape hair without damaging follicles.

Lots of drugstore shampoos contain some artificial ingredients that can further cause hair damage. Not so with Verbs vegan shampoo, which is infused with hydrating moringa and sunflower seed extracts to thoroughly clean your mane. Plus, its free of harmful sulfates and parabens, and its cruelty-free.

If youve tried changing products and are still experiencing rapid hair loss, dont waste any time getting to a doctor. If a serious hair loss problemis diagnosed in time, it may be reversible within three to six months.

Dr. Ziering starts with topical medications like minoxidil or finasteride, an easy at-home treatment. In some cases he may move on to oral finasteride, which blocks DHT. DHT is a type of testosterone that works wonders for men when were going through puberty, but is not so friendly to your follicles when you get older.

We also use laser therapy, where the patient wears a cap that stimulates the mitochondria, improving cell growth, says Ziering. Finally we also do exosomes injections, which is a form of stem cell therapy. The treatment nourishes the hair and basics all helps wimpy hair grow thicker.

Finally, if it comes down to it, actual surgery may be an option, and doctors like Ziering can help with hair restoration and transplants.

Maybe the most important part of stress-related hair loss is to keep things in perspective.

Im a medical doctor. I deal with the patient as a whole, says Dr. Ziering. Its important to remember that we are all in this together. Find something thats good for your body: Meditation, exercise, rest, yoga, or whatever makes you feel better. Eat a high protein diet with fresh super greens and legumes. Dont keep stress bottled up! Find somebody that you can talk to and share your feelings. Dont be ashamed if its time to do something about losing your hair. Do whats necessary to break that stressful cycle and feel like youre doing something positive for yourself.

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How To Treat Stress-Related Hair Loss During COVID-19 - The Manual

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OWINGS MILLS, Md., Sept. 24, 2020 /PRNewswire/ --Chesapeake Urology, an affiliate of United Urology Group, recently welcomed three new physicians to its growing team of specialists and general urologists. The addition of David A. Levy, M.D., Devang Sharma, M.D., and Katherine Smentkowski, M.D., continues to expand Chesapeake Urology's reach into specialties such as prostate cancer, men's sexual and reproductive medicine, reconstructive surgery, as well as general urology.

David A. Levy, M.D. is a recognized expert in prostate cryosurgery, an outpatient curative prostate cancer procedure that he has been performing for the past 15 years. He has published numerous peer-reviewed manuscripts on prostate cryosurgery detailing patient selection criteria, procedure-related side effects and outcomes analyses, as well as the definition of treatment success for the procedure for patients with newly diagnosed prostate cancer and those treated for recurrence following failed radiation therapy.

Dr. Levy also has substantial experience in prostate cancer nutrition and directed a Prostate Cancer Nutrition Genetics Clinic in Cleveland where he treated more than 450 prostate cancer patients in a non-operative manner over the past six years.

He graduated from Washington University in St. Louis in 1985. He received his Doctorate of Medicine degree from the Chicago Medical School and completed his General Surgery Internship and Urology Residency at University Hospitals of Cleveland, Case Western Reserve University. Following his residency, Dr. Levy completed a fellowship in Urologic Oncology at the MD Anderson Cancer Center in Houston, Texas.

Dr. Levy sees patients at Chesapeake Urology's Hanover and Saint Agnes Hospital/Angelos Medical Pavilion offices.

Devang Sharma, M.D. is a comprehensive men's health specialist with fellowship training in male infertility, sexual dysfunction, and reconstructive surgery. In addition to general urology, his practice is focused on men with urinary complaints related to the bladder, prostate, or urethra, erectile dysfunction, Peyronie's disease, low testosterone, fertility concerns, and prostate cancer survivorship. He brings advanced training and expertise in contemporary treatments including no-scalpel vasectomy, Greenlight photovaporization of the prostate, UroLift, penile injection and shockwave therapy, penile implants, artificial urinary sphincters and slings, urethral reconstruction, and microsurgical techniques including vasectomy reversal, varicocele repair, sperm extraction, and spermatic cord denervation.

Dr. Sharma graduated summa cum laude from the University of Maryland with a degree in Bioengineering. He graduated with honors from the Geisel School of Medicine at Dartmouth, then completed Urology Residency and Andrology Fellowship at the University of Virginia.

Dr. Sharma sees patients at Chesapeake Urology's office at Holy Cross Germantown Hospital.

Katherine Smentkowski, M.D.focuses on general urology as well as bladder and kidney cancer, kidney stones and minimally invasive and robotic surgery for upper urinary tract reconstruction. Her fellowship training at Thomas Jefferson University focused on robotic management of both benign and malignant urological conditions. This included prostate, bladder, kidney and ureteral cancers as well as reconstructive techniques for ureteropelvic junction obstruction and ureteral strictures.

Dr. Smentkowski earned her Bachelor of Science degree in Physiology and Neurobiology from the University of Maryland, College Park, MD. She received her Medical Doctorate at Eastern Virginia Medical School (EVMS) in Norfolk, VA where she was involved in community outreach and elected into the Alpha Omega Alpha Honor Society. She went on to complete Urological Residency at EVMS as well as a Fellowship in Minimally Invasive and Robotic Surgery at the Thomas Jefferson University in Philadelphia, PA.

Dr. Smentkowski sees patients in Chesapeake Urology's Columbia office.

About Chesapeake Urology

Chesapeake Urology, an affiliate of United Urology Group, is a fully-integrated urology practice providing a comprehensive array of urologic services to its patients. The Company operates 24 medical offices and 17 AAAHC-certified ambulatory surgery centers in Anne Arundel, Baltimore, Harford, Howard, Carroll, Montgomery, Prince George's, Wicomico, Worchester counties in Maryland, Baltimore City, and Sussex County, Delaware, and has a staff of more than 900 including 90 physicians, 84 who are urologists. Chesapeake Urology has been named one of the top places to work in healthcare nationally by Modern Healthcare magazine and Becker's ASC Review, and locally by the Baltimore Sun, Baltimore magazine and the Baltimore Business Journal. For additional information, please visit ChesapeakeUrology.com.

Media Contact: Patricia Schnably, Senior Vice President, Marketing & CommunicationsUnited Urology Group25 Crossroads Drive, Suite 306, Owings Mills, MD 21117443-738-8107[emailprotected]

SOURCE Chesapeake Urology

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Hair loss can be the result of complex environmental and genetic processes. In the former camp lies responses to stressful situations and certain cancer treatments. In the genetic camp is androgenetic alopecia - commonly known as pattern baldness. It usually runs in the family, which, on the face of it, seems dispiriting.

Fighting genetics may seem like a losing battle but evidence does suggest you can reverse this form of hair loss.

One strategy that has yielded surprising results is applying a melatonin solution to the scalp.

Most people will associate melatonin with sleep - the hormone plays a central role in the bodys sleep-wake cycle.

As the National Sleep Foundation explains, its production increases with evening darkness, promoting healthy sleep and helping to orient our circadian rhythm.

READ MORE:Hair loss treatment - Dr Sara explains the best type of shampoo to stimulate hair growth

Circadian rhythms are 24-hour cycles that are part of the bodys internal clock, governing important processes such as the sleep-wake cycle.

Theres evidence that the benefits of melatonin extend to treating hair loss.

This is because melatonin also affects hair growth, as the hair growth cycle in mammals is under circadian control, according to The Lifespan Research Institute, a research body that focuses on anti-ageing compounds.

"As with other circadian cycles, the hair growth cycle becomes dysregulated and lower in amplitude with age," explains the research body.

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In a randomised double-blind study of 40 women with hair loss, melatonin solution applied to the scalp increased hair growth significantly relative to placebo.

What's more, in a study published in the International journal of trichology, 1891 male and female patients with androgenic alopecia applied a topical melatonin solution for three months.

At three months 61 percent of patients had no hair loss, compared to 12.2 percent at the start; 22 percent had new hair growth at three months compared to four percent at baseline.

The incidence of seborrheic dermatitis also declined, from 34.5 percent at baseline to 9.9 percent at three months.

Seborrheic (seb-o-REE-ik) dermatitis is a common skin condition that mainly affects your scalp.

The skin condition can cause an itchy, flaky rash, which may lead to hair loss due to excessive itching.

According to the NHS, finasteride and minoxidil are the main treatments for male pattern baldness.

"Minoxidil can also be used to treat female pattern baldness. Women shouldn't use finasteride," explains the NHS.

There are a number of drawbacks to consider before taking these treatments.

According to the NHS, these treatments:

These treatments:

Alternatively, some wigs are available on the NHS, but you may have to pay unless you qualify for financial help.

While considering your options, you may benefit from some psychological support.

Your GP may be able to help you get some counselling or you can join a support group, adds the NHS.

The rest is here:
Losing hair fast? Applying this natural solution to the scalp resulted in new hair growth - Express

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Diabetes is a chronic condition that affects how your body uses insulin. This hormone controls how much blood sugar, also known as glucose, is released into your cells to be used as energy.

Over 34 million people in the US have diabetes, according to the Centers for Disease Control and Prevention (CDC). While there is no cure for diabetes, it can be managed with lifestyle and dietary changes, or medication like insulin.

Here's what you need to know to manage diabetes and lower blood sugar levels.

With all types of diabetes, your body either doesn't produce enough insulin, or isn't able to use insulin effectively.

Insulin is necessary to move blood sugar into your cells, where it is stored and used for energy. Without insulin, a condition called hyperglycemia can occur, where blood sugar builds up in your bloodstream instead of traveling into your cells.

Type 1 diabetes makes up just 10% of all diagnosed diabetes cases in the US, according to the CDC. It is most commonly diagnosed in children, teenagers, and young adults.

Although the cause is unknown, type 1 diabetes may be due to an autoimmune response caused by an infection or other trigger. Your body mistakenly attacks and damages the beta cells in your pancreas that make insulin, so little or no insulin is produced.

There are not many risk factors for type 1 diabetes, though genetics is believed to play a role. The odds of the children of men with type 1 diabetes developing the condition is 1 in 17, according to the American Diabetes Association (ADA). For the children of women with type 1 diabetes, the odds are 1 in 25 if the woman is under the age of 25, or 1 in 100 after the age of 25.

A type 1 diabetes diagnosis requires some important lifestyle changes. You must take insulin every day in order to survive. Your blood sugar level needs to be frequently monitored. It's essential to carefully plan your meals and count carbohydrates.

"This can be a frustrating and tiresome adjustment, but it is crucial that patients educate themselves on how certain foods impact glucose levels," says endocrinologist Rocio Salas-Whalen, MD, of New York Endocrinology.

Type 2 diabetes makes up about 90% of all diagnosed diabetes cases in the US. It is most often diagnosed in adults, but the CDC notes that it is becoming increasingly diagnosed in children and teenagers.

With type 2, your body can produce insulin, but it is not able to use it effectively. This is called insulin resistance, which happens when your liver, muscle, and fat cells don't effectively take in the blood sugar from your blood to use it for energy. As a result, your blood sugar level increases, which can eventually lead to type 2 diabetes.

You are more at risk for type 2 diabetes if you:

In addition to eating a healthy diet, it's very important for people with type 2 diabetes to maintain a healthy weight, Salas-Whalen says, because this can also help them control blood sugar levels.

Pregnant people may develop gestational diabetes, which is caused by the body's inability to produce the extra insulin needed during your pregnancy. Gestational diabetes can put your baby at risk for health problems later in life, such as obesity or type 2 diabetes.

About 7% of pregnant people in the US are diagnosed with gestational diabetes. It usually begins in the middle of your pregnancy, without any symptoms. You should be tested for it between your 24th and 28th weeks of pregnancy. It typically goes away after your baby is born, but you will have a higher risk of developing type 2 diabetes later in life.

If you have gestational diabetes, you'll need to work with your doctor to develop a healthy eating plan, and you should also remain physically active to help keep your blood sugar levels low. If a healthy diet and exercise don't lower your blood sugar levels, you may need to take insulin.

Prediabetes is a condition where your blood sugar levels are elevated, but not yet high enough for a diabetes diagnosis. However, if left untreated, prediabetes can develop into type 2 diabetes.

More than a third of all US adults over 88 million have prediabetes, yet 84% of them don't know they have it, the CDC notes.

With lifestyle changes like a healthy diet, losing weight, and getting regular exercise, it's possible for prediabetes to be reversed or delayed. Your doctor may also prescribe medication to help lower your blood sugar level.

"A prediabetic still has the potential to avoid diabetes, which should be avoided in every possible way," Salas-Whalen says.

The signs of all types of diabetes can include the following:

However, these symptoms develop slowly over time, and it may be difficult to recognize them, especially if you have type 2 diabetes. The signs of type 1 diabetes may be more severe, and can also include nausea or vomiting.

Target blood sugar levels are different for those with diabetes. The follow chart depicts normal blood sugar levels for diabetics and non-diabetics:

Yuqing Liu/Insider

Many people with diabetes with need to learn how to check their blood sugar multiple times a day using a glucose meter or a continuous glucose meter.

"Try not to think of blood sugars as 'good' or 'bad' or as a reflection of how well or bad you are doing," says Shelley Nicholls, DNP, APRN, CDCES, director of patient education at the Diabetes Research Institute. "Having a good understanding of what affects blood sugars and which of them a person can control or influence is the best tool a person with diabetes can have."

To treat diabetes, it is important to lower your blood sugar level and make sure it stays in a healthy range.

Doing this will not only increase your energy, but according to the ADA, each percentage point of A1C lowered reduces the possibility of long-term health complications which could include serious heart, kidney, brain, eye, or foot problems by 40%.

These are some of the best natural ways to lower and manage your blood sugar levels over time:

It's important for people with diabetes to be careful about the foods they eat because they can impact your blood sugar levels."Some foods can worsen diabetes, while other foods can actually improve diabetes control," Salas-Whalen says.

Carbohydrates and fiber especially affect your blood sugar levels in the following ways:

It can be helpful to follow a diet to manage your diabetes, as planning out your meals and snacks will help you control blood sugar levels effectively.

"Every person has different needs, so there is no one diet that is recommended for people with diabetes," Nicholls says. "The best option is to meet with a dietitian to determine individual needs and goals."

Here are some of the best diets for diabetics:

The Mediterranean diet includes plant-based foods, lean meats, and healthy fats.

According to a 2009 study published in Diabetic Medicine, people who strictly followed a Mediterranean diet for three months had lower A1C percentages and lower blood sugar levels after meals than those who followed it less strictly.

The DASH diet, which stands for Dietary Approaches to Stop Hypertension, is mainly used to lower blood pressure, but it can also help lower blood sugar.

A 2017 study published in the ADA journal Diabetics Spectrum suggests that the DASH diet can lower insulin resistance and help you lose weight. A 2016 study published in the journal Nutrition found that a DASH diet can also help lower the risk for gestational diabetes by as much as 71%.

This high-fat, low-carb diet limits carbs to 20 to 50 grams daily in an effort to put your body in the metabolic state of ketosis, where you burn fat instead of carbs for fuel.

A 2017 study published in Nutrition & Diabetes found that overweight adults with type 2 diabetes or prediabetes who followed a keto diet had lower A1C levels and lost over 4% more weight after one year than those who followed a moderate-carbohydrate/low-calorie/low-fat diet.

There are also some health risks associated with the keto diet. If you have type 1 diabetes, your lowered blood sugar level may lead to hypoglycemia and serious brain, kidney, or liver complications.

Another issue associated with this diet are "keto flu" symptoms that may include headache, nausea, and vomiting. It's important to consult with your doctor or a registered dietitian before starting a keto diet.

People with type 1 diabetes need to take insulin every day in order to survive. If people with type 2 diabetes are unable to reach their blood sugar target levels with diet and exercise, they may also need medication like insulin or metformin.

People with type 1 diabetes generally need to take three to four doses of insulin every day, according to the ADA. Women with gestational diabetes may need to take insulin daily during their pregnancy if their bodies aren't producing enough of it naturally. Many people with type 2 diabetes may need one dose each day with or without other medications.

Insulin is injected in the fat under your skin using a syringe, insulin pen, or pump. It should be injected in the same area of the body, but not the same place each day. It's best to inject insulin at mealtime so it is more effectively processed in your body.

There are many different types of insulin, and your doctor may even prescribe two or more of the following types:

"The challenge with taking insulin is that it's tough to know precisely how much to take," Nicholls says. The amount is based on factors that may change throughout the day, such as food, exercise, and stress. "So, deciding on what dose of insulin to take is a complicated balancing act."

Taking an extra dose of insulin can also help you lower blood sugar fast if it's an emergency, though you may want to check in with your doctor beforehand.

If you have type 2 diabetes, your doctor may prescribe metformin, a medication that lowers blood sugar by slowing your liver's production of glucose. It is the drug most commonly prescribed to treat type 2 diabetes.

Metformin is available in a liquid, pill, or extended-release tablet. You take it orally at mealtime two to three times a day. The extended-release tablet only needs to be taken once daily.

According to a 2012 scientific review published in Diabetes Care, metformin can effectively reduce A1C levels for people with type 2 diabetes by an average of 1.12%.

Although it's possible to control your diabetes and lower blood sugar levels, there is no specific cure.

"Because of this reality, lifestyle changes must be permanent and not temporary in order to avoid the potential long-term complications of diabetes," Salas-Whalen says.

To develop the best plan of treatment for diabetes, it's important to meet with your doctor for individualized recommendations.

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Paul L. Nguyen, MD, discusses standard and investigational treatment options in high-risk prostate cancer.

Paul L. Nguyen, MD, senior physician and director of Genitourinary Clinical Center for Radiation Oncology at Dana-Farber Cancer Institute, as well as a professor of radiation oncology at Harvard Medical School, discusses standard and investigational treatment options in high-risk prostate cancer.

Typically, patients with high-risk prostate cancer are treated with standard androgen deprivation therapy with a gonadotropin-releasing hormone agonist plus an antiandrogen, Nguyen says. However, novel agents are in development to try to improve upon standard treatment.

For example, enzalutamide (Xtandi) is currently being tested in the randomized phase 3 ENZARAD trial in men with high-risk, localized prostate cancer, says Nguyen. Additionally, the phase 3 ATLAS trial is evaluating apalutamide (Erleada) in patients with high-risk disease who are receiving primary radiation therapy.

Abiraterone acetate (Zytiga) was tested in the STAMPEDE trial, Nguyen adds. Although data from study were published, the field awaits additional follow-up to determine whether patients with node-negative nonmetastatic prostate cancer derived benefit from abiraterone.

Additionally, other studies such as the phase 3 DASL-HiCaP trial, which is evaluating darolutamide (Nubeqa) in very high-risk prostate cancer, and the phase 3 Predict-RT trial, which is evaluating abiraterone plus apalutamide in patients with high genomic risk disease, are ongoing, concludes Nguyen.

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Dr. Nguyen on Standard and Investigational Treatment Options in High-Risk Prostate Cancer - OncLive

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People with diabetes have a more difficult time regulating their blood sugar. Those with type 1 diabetes are not able to produce insulin, the hormone that helps the body convert blood sugar into energy. And those with type 2 diabetes cannot use insulin effectively.

As a result, blood sugar levels are often much higher for people with diabetes, especially in the morning. Here's why.

As your body prepares to wake for the day, it releases glucose stored in the liver to give you the energy you need to get going. However, people with diabetes are not able to utilize this blood sugar, so roughly half of diabetics experience high blood sugars in the morning. This is known as the dawn phenomenon.

If you have diabetes, your doctor will work with you to set a target range for your blood sugars. In general, blood sugar levels between 70 to 130 mg/dl are considered healthy for diabetes.

If your levels are consistently above your target in the morning, and you have not eaten yet, you might be experiencing dawn phenomenon. This is most common in people with type 2 diabetes.

Blood sugars typically peak about 2 to 3 hours before waking and can remain high as you wake up. For most people, that means the early morning hours, but if you have an abnormal sleep schedule you can experience this spike at any time.

"For individuals who work night shifts, the 'dawn' phenomenon may occur at dusk, since it's related to an individual's normal waking time, not the specific time of the day," says Joseph Barrera, MD, an endocrinologist with Mission Hospital in Orange County, California.

The Somogyi effect is a second explanation for high blood sugars in the morning, and this occurs most often in people with type 1 diabetes. It happens when people experience hypoglycemia or low blood sugar during the night. In an attempt to correct that, the body releases more stored glucose, which can then lead to high blood sugars in the morning.

The Somogyi effect is more rare than the dawn phenomenon, but that's mostly because fewer people have type 1 diabetes than type 2 diabetes. When a 2015 study published in Diabetology & Metabolic Syndrome followed 85 people with type 1 diabetes, it found that 82.4% of them had high blood sugars in the morning, and 60% of those were caused by the Somogyi effect, compared with just 12.9% caused by the dawn phenomenon.

To determine if your high blood sugars in the morning are caused by the Somogyi effect, Barrera says you'll need to see your blood sugar levels about 4 to 5 hours before you wake up, which can be done with a continuous glucose monitor.

You should talk to your doctor if you regularly experience high blood sugars in the morning, Barrera says. Your team will make recommendations on changing your treatment regimen that might help you avoid this morning hyperglycemia.

"High blood sugars in the morning can generally be addressed by careful attention to a diet and exercise regimen, and adjustments in diabetic medication by a qualified health professional," Barrera says.

To avoid dawn phenomenon, your doctor might tell you to take these steps:

People who continue to have trouble with the dawn phenomenon might be advised to take insulin before bed, Barrera says. However, this has to be done carefully, so that it doesn't cause the Somogyi effect.

People who experience the dawn phenomenon often find that it gets worse over time. In fact, it's considered an indicator that diabetes is progressing, so it's important to talk to your doctor about treating it.

On the flip side, making the necessary changes to regulate the dawn phenomenon can lower blood sugar over time. In fact, research has found that it can result in a 0.5% decrease in A1C levels a long-term measure of blood sugar which can reduce your risk for health complications from diabetes.

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