StemCell Therapy

LEXINGTON, Mass., Sept. 25, 2020 (GLOBE NEWSWIRE) -- LogicBio Therapeutics, Inc. (Nasdaq:LOGC), a genome editing company focused on developing medicines to durably treat rare diseases in pediatric patients, today announced CEO Fred Chereau will present at the Jefferies Virtual Gene Editing/Therapy Summit on Friday, October 2, 2020 at 11:30 AM, ET.

A live audio webcast of the presentation will be available under the Events and Presentations section of LogicBios website. A replay of the presentation will become available approximately one hour after the event and will be archived for 30 days.

About LogicBio Therapeutics

LogicBio Therapeutics is a genome editing company focused on developing medicines to durably treat rare diseases in pediatric patients with significant unmet medical needs using GeneRide, its proprietary technology platform. GeneRide enables the site-specific integration of a therapeutic transgene in a nuclease-free and promoterless approach by relying on the native process of homologous recombination to drive potential lifelong expression. Headquartered in Lexington, Mass., LogicBio is committed to developing medicines that will transform the lives of pediatric patients and their families. For more information, please visit http://www.logicbio.com

Contacts:

Investors:Matthew Lane

Gilmartin Investor Relation

matt@gilmartinir.com

Media:Stephanie Simon

TenBridge Communications

Stephanie@tenbridgecommunications.com

617-581-9333

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LogicBio Therapeutics to Present at the Jefferies Virtual Gene Editing/Therapy Summit October 2, 2020 - GlobeNewswire

DetailsCategory: DNA RNA and CellsPublished on Friday, 25 September 2020 11:52Hits: 367

Focus on effect of SVecTM on downregulation of pathological immune responses underlying the destruction of own cells in DM1 and in MS patients

Investment of 0.6 million (US$0.7 million) in animal proof-of-principle studies

LEIDEN, The Netherlands and SEVILLE, Spain I September 25, 2020 I 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 Amarnas SVecTM gene 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 Amarnas 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 Therapeutics 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 based therapies, the sooner patients will experience the positive impact of our solution on their lives.

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 companys 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

Link:
Dutch Amarna Therapeutics enters research collaboration with Spanish FPS, examining the efficacy of its SV40-based SVecTM gene delivery vector...

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.

Link:
What is diabetes? A comprehensive guide to lower blood sugar and manage the condition - Insider - INSIDER

September 25, 2020 -A group of Senators has introduced a bill that would expand access to the Medicare Diabetes Prevention Program through telehealth.

S 4709 was introduced this week by Senators Tim Scott (R-SC), Mark warner (D-VA), Kevin Cramer (R-ND), Kyrsten Sinema (D-AZ), Tom Cotton (R-AR) and Tina Smith (D-MN). Titled the Prevent Diabetes Act, it addresses a long-standing issue with a Medicare program designed to help members at increased risk of developing type 2 diabetes.

Its no secret that diabetes is a disease that has disproportionately affected minority communities across the country, Warner said in a press release. To ensure that all individuals have the tools needed to combat this preventable disease, the Prevent Diabetes Act would help expand access to virtual classes under the existing Medicare Diabetes Prevention Program. This commonsense and cost-saving expansion will ensure that more Americans at-risk of developing diabetes who are living in either rural or medically underserved communities, can participate in this critical program that has been proven to delay the full onset of this preventable disease.

The original Diabetes Prevention Programwas developed by the National Institutes of Healths National Institute of Diabetes and Digestive and Kidney Disease (NIDDK), and focused on in-person classes and one-on-one coaching. Based on that model, which is administered by the Centers for Disease Control and Prevention, the Centers for Medicare & Medicaid Services created the National Diabetes Prevention Program for Medicare beneficiaries and launched that program in 2018.

But the Medicare Diabetes Prevention Program Expanded Model conducted by the Center for Medicare and Medicaid Innovation doesnt reimburse care providers for using connected health platforms. Telehealth and mHealth advocates have been lobbying for years to add those services, saying a virtual platform would reach far more people at risk and enable providers to make better use of limited resources.

More than 70 healthcare providers are now listed on the CDCs DPP website, though only a handful have been recognized as offering proof that their online programs reach recognized benchmarks for activity and weight loss.A growing number of programs are using virtual careas a means of expanding the programs reach and making the most of limited resources, and theyre asking CMS to cover those services.

Last year, a group of Senators including those sponsoring the Prevent Diabetes Act wrote a letter to Health and Human Services Secretary Alex Azar and CMS Administrator Seema Verma asking that the program be expanded to include CDC-recognized virtual DPP providers.

Virtual delivery of MDPP has the ability to empower beneficiaries to access MDPP regardless of where they live, and in the format of their choosing, the Senators wrote. Because of the outcome-focused reimbursement structure, CMS has insulated from reimbursing for ineffective treatment. Medicare Advantage plans have also been vocal in their desire to deploy virtual DPP for their beneficiaries. Given this, we also encourage CMS to consider ways for Medicare Advantage plans to use virtual providers to ensure that all Medicare beneficiaries have access to a CDC fully-recognized DPP.

In April, that same group lobbied again for the inclusion of virtual care providers, saying the coronavirus pandemic has created further barriers to in-person care.

The new bill, which as of September 25 contains no text or summary, is supported by several organizations, including the American Diabetes Association, American Medical Association, Connected Health Initiative and National Kidney Foundation, along with digital health companies Livongo, Noom and Omada Health.

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New Bill Would Add Telehealth to Medicare Diabetes Prevention Program - mHealthIntelligence.com

Frequent hot tub bathinghada positive impact on glycemia, blood pressure, and body weight in patients with type 2 diabetes, in the first real-world study to analyze the effect of this type of heat therapy in such individuals.

"The data from our analysis showed that the frequency of hot tub bathing could have beneficial influences on diabetic control, hypertension, and obesity even after adjusting for confounding factors," HisayukiKatsuyama, MD, told Medscape Medical News.

Katsuyama presented the findings as a poster at the virtual European Association for the Study of Diabetes (EASD) Annual Meeting 2020. The study aimed to explore the real-world influence of habitual hot tub bathing on the control of type 2 diabetes and other cardiovascular risk factors.

"Heat therapy, shown here with hot tub bathing, can be one effective therapeutic option for type 2 diabetes in daily life. An alternative form of heat exposure might be nutrition therapy and exercise," noted Katsuyama, from Kohnodai Hospital, Ichikawa, Chiba, Japan.

But Lucy Chambers, PhD, head of research communications at Diabetes UK, was not so enthusiastic about the results.

"While this research suggests there might a link between taking regular hot baths and better health in people with type 2 diabetes, it raises more far more questions than it answers," she said.

"It could be that people who bathe more frequently have a healthier lifestyle in general perhaps they are more physically active we just don't know from the limited data collected."

"It isnot possible to say from this research whether bathingcan benefit yourphysicalhealth," she noted in a statement from Diabetes UK.

Prior to the current study, there were no large studies looking at the effects of hot tub bathing on metabolic parameters in patients with diabetes.

One cohort study in Finland revealed that frequency of sauna bathing was inversely associated with fatal cardiovascular events in middle-aged adults (BMC Med. 2018;16:219). And a prior small before-and-after study in patients with diabetes showed a significant reduction in fasting glucose and A1c (N Engl J Med. 1999;341:924-925), Katsuyama noted.

Most homes in Japan, where bathing is a traditional and common practice, have hot tubs, which prompted the researchers' idea for a real-world study, he explained.

Katsuyama and colleagues studied the frequency of hot-tub bathing using a self-reported questionnaire completed by 1297 patients with type 2 diabetes who regularly visited Kohnodai Hospital over 6 months.

They took anthropometric measurements and used blood test results to analyze associations between hot tub use and different variables. Patients were divided into three groups according to frequency of bathing: group 1, 4 baths/week; group 2, 1-<4 baths/week; and group 3, < 1 bath/week.

Mean age was 67 years, weight was 67 kg, BMI was 25.9 kg/m2, and A1c was 7.2%. There were more men than women (713/584).

Most participants, 693, were in group 1 ( 4 baths/week), 415 were in group 2 (1-< 4 baths/week); and 189 were in group 3 (< 1 bath/week).

The mean frequency of bathing was 4.2 times/week and mean duration of bathing was 16 minutes.

Body weight, BMI, waist circumference, diastolic blood pressure, and A1c were all significantly better in group 1 (most frequent bathing) compared with group 3 (least frequent bathing) (Table).

Table. Effects of Frequency of Hot Tub Bathing on Metabolic Parameters

Group 1 4 baths/week

BP = blood pressure

Katsuyama pointed out that animal studies have suggested heat stimulation might improve insulin sensitivity and enhance energy expenditure, an effect also observed during exercise.

"I expect that patients can benefit in a similar way with heat therapy," he added, noting that hot tub bathing might be particularly beneficial for patients who cannot exercise.

"It would probably [also] be beneficial for the prevention of diabetes," and potentially, diabetes complications, he said. Indeed, "cohort studies have shown the possibilities that heat therapy could prevent cardiovascular diseases."

Katsuyama pointed out that a key strength of the study was the relatively large number of participants compared with previous studies.

But there were also limitations due to the nature of the cross-sectional study, which "means we cannot guarantee causality, and secondly, various confounding factors, such as diet and other life habits, could influence the results."

"A well-designed prospective study will be needed to confirm the beneficial effects of the heat therapy," he concluded.

EASD 2020. Presented September 22, 2020. Abstract 342.

Katsuyama has reported no relevant financial relationships.

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Hot Tubs Improve A1c, BMI, and Blood Pressure in Type 2 Diabetes - Medscape

Dublin, Sept. 25, 2020 (GLOBE NEWSWIRE) -- The "Worldwide Diabetes Reusable Insulin Delivery Pen Market: Demand, Insights, Trends, Analysis, Opportunities, Growth Potential and Forecast to 2026" report has been added to ResearchAndMarkets.com's offering.

The Worldwide Diabetes Reusable Insulin Delivery Pen Market size is expected to touch US$ 6 billion by 2026.

The report offers the most up-to-date industry data on the actual market situation and future outlook for the worldwide diabetes reusable insulin delivery pen market. The report provides historical market data for 2013 - 2019, and forecasts from 2020 until 2026.

The report contains a granular analysis of the present industry situations, market demands, reveal facts on the market size, reusable insulin pen volume, revenues for reusable insulin delivery pen, and illustrative forecast to 2026. It also provides 16 countries with an all-round analysis of an overall number of patients with diabetes and insulin users. A comprehensive analysis has been done on the market share of the countries-based market.

The report explores essential insights into worldwide diabetes reusable insulin delivery pen market for the top 16 countries, comprising the United States, the United Kingdom, Canada France, Italy, Spain, Germany, Netherlands, Poland, Sweden, Turkey, Australia, Japan, China, India, and Brazil until 2026. The report also provides a detailed description of growth drivers and inhibitors of the worldwide diabetes reusable insulin delivery pen market.

The report concludes with the profiles of major players in the worldwide diabetes reusable insulin delivery pen market. The key market players are evaluated on various parameters such as company overview, product portfolios and recent development of the worldwide diabetes reusable insulin delivery pen market

Key Questions Answered in this Market Research Report:

The Major Companies Dominating this Market for its Products, Services and Continuous Product Developments are:

Key Topics Covered:

1. Executive Summary

2. Diabetes Reusable (Cartridge) Insulin Delivery Pen Users (Volume), 2013 - 2026

3. Diabetes Reusable (Cartridge) Insulin Delivery Pen Market (Value), 2013 - 2026

4. Diabetes Reusable (Cartridge) Insulin Delivery Pen Market Share, By Users (%) 2013 - 2026

5. Diabetes Reusable (Cartridge) Insulin Delivery Pen Market Share (%), 2013 - 2026

6. Key Market Drivers & Inhibitors of the Diabetes Reusable (Cartridge) Insulin Delivery Pen Market6.1 Market Drivers6.2 Market Inhibitors

7. Diabetes Reusable (Cartridge) Insulin Delivery Pen Market & Forecast (2013 - 2026) - Major 16 Countries Data Analysis7.1 United States7.1.1 Overall Diabetes Population & Forecast (Volume) 7.1.2 Insulin Users & Forecast (Volume) 7.1.3 Diabetes Reusable (Cartridge) Insulin Delivery Pen Users (Volume) 7.1.4 Diabetes Reusable (Cartridge) Insulin Delivery Pen Market & Forecast (Value) 7.2 Canada7.3 Germany7.4 France7.5 Italy7.6 Spain7.7 United Kingdom7.8 Netherlands7.9 Poland7.10 Sweden7.11 Turkey7.12 Australia7.13 Japan7.14 China7.15 India7.16 Brazil

8. Key Companies Analysis8.1 Business Overview8.2 Insulin Pen Products Portfolio8.3 Recent Development

For more information about this report visit https://www.researchandmarkets.com/r/nmbp1s

Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.

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Worldwide Diabetes Reusable Insulin Delivery Pen Market Report 2020: Demand, Insights, Trends, Analysis, Opportunities, Growth Potential and Forecast,...

A leading manufacturer of automated insulin delivery systems, Dexcom (NASDAQ:DXCM) signed a five-year collaboration agreement with the University of Virginia on Thursday . The company will fund research at the university that could expand its addressable patient population.

Dexcom already has clinical trial evidence that shows its constant glucose monitoring (CGM) technology reduces the amount of time Type 1 diabetes patients spend with blood sugar levels that are too high or too low. Through its collaboration with the university, the company will test its CGM technology for use among people with Type 2 and gestational diabetes, as well as for hospitalized patients.

Image source: Getty Images.

The University of Virginia's Center for Diabetes Technology will lead the research efforts, but the collaboration will employ experts from multiple disciplines across the University of Virginia System.

This isn't the first time these two have conducted research as partners. In 2019, the collaboration partners presented successful results of a trial with Type 1 diabetes patients that used Dexcom's CGM technology to control their blood sugar levels.

In 2020, Dexcom expects revenue to grow by about 25% to around $1.85 billion. While there has been some uptake of Dexcom's CGM systems among insulin-dependent Type 2 patients, the relative lack of evidence of a benefit is severely limiting the company's total revenue.

In 2017, the American Diabetes Association estimated the number of Type 1 diabetes cases in the U.S. at 1.3 million. In 2012, it estimated the number of Type 2 diabetes patients at 27.8 million.

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Dexcom and University of Virginia to Advance Diabetes Research Together - Motley Fool

My name is Dr. Vishwanath Pattan and I am the Medical Director of Endocrinology at Wyoming Medical Center in Casper. Endocrinology is the study of hormones, and as an endocrinologist I treat patients for a wide variety of diseases related to hormonal deficiencies and imbalances. That includes many patients with diabetes.

At my clinic, Wyoming Endocrine and Diabetes, I treat patients from across Wyoming, and I have noticed an alarming trend for my diabetic patients in relation to the COVID-19 pandemic: an inability to monitor and control glucose or maintain weight in the summer months.

In a typical year, diabetic patients tend to lose weight and achieve better glucose control in the summer because they are able to live a much more active outdoor lifestyle. During the winter, I often see the opposite trend of added weight, less stable glucose levels, seasonal depression, and an increase in overall stress.

2020, however, has not been a typical year, and I have noticed a deviation from the typical summer pattern in my diabetic patients. Many of these patients have actually gained weight, exhibited less than stable glucose control, and had an increase in their overall stress levels.

I have a few theories on why this might be. When COVID-19 was first acknowledged as a public safety concern, people were quick to stock up on everything they could. As we know, the shelf life of heavily processed foods is what makes them some of the first to go amidst a global crisis.

These foods are built to stand the test of time, but for a diabetic patient, they can easily contribute to an unsafe fluctuation of glucose. There was also a lot of uncertainty, fear, and confusion that caused millions to be left without a job and the added stress of strict isolation measures. People were forced to live a much more sedentary lifestyle, whether they wanted to or not, and eat food that does not promote a healthy glucose level. I also saw a major decrease in correspondence with many of my patients with uncontrolled diabetes, further contributing to an atypical summer for the diabetic population.

So, why does this raise a red flag?

Although patients with diabetes are not at any further risk of contracting COVID-19, they are much more likely to suffer greater complications because of it. These complications could lead to the need for ventilator support, further intensive care, and even higher death rates by several folds. This leads me to my main concern with so many of my diabetic patients experiencing poor glucose control prior to a season in which it is already difficult to manage: A person with uncontrolled diabetes in the summer is more likely to have uncontrolled diabetes in the winter, especially during a global pandemic. With the dual-threat of COVID-19 and this upcoming flu season, it is paramount that people with diabetes put their health and safety at the forefront.

I strongly urge people with diabetes and their families to safely support one another through the winter months with the helpful information discussed below.

People with diabetes should:

Monitor glucose regularly, per your healthcare providers recommendation

Make sure to follow up with your healthcare providers, either in person or by utilizing virtual visits. (Healthcare facilities take utmost care and precautions, and put your health as a top priority, so in-person visits should be safe). In the coming months, it is essential to keep your providers up-to-date on your progress, and you should discuss individualized glucose goals with your doctor

Contact your healthcare provider immediately if your blood glucose is above target

Remain compliant with medication regimens and dietary treatment plans

Aim to eat a balanced diet, exercise regularly and get adequate sleep at least between 7 and 8 hours per night

Maintain a healthy immune system by prioritizing glucose control, managing stress levels and taking a Vitamin D supplement. In Wyoming, most people are naturally deficient during the winter months and are encouraged to seek their healthcare providers recommendation for proper supplementation.

Family members of diabetic patients should:

Encourage your loved one to keep appointments with healthcare providers

Assist them with technology for virtual visits

Avoid social gatherings, practice proper hand hygiene, and always wear a mask in public spaces to keep your loved one safe

Help with cooking balanced and healthy meals

Ensure that your loved one has at least 4 to 6 weeks worth of diabetic supplies on hand in case of supply issues later on. These include testing strips, insulin, and necessary insulin administration equipment

Remind patients to take their medication on time and encourage compliance with glucose monitoring

Help to maintain a stress-free environment at home

The rest is here:
Concerning trend found in patients with diabetes - Green River Star

Consuming more than 3 cups/day of white ricesignificantly increases the risk of diabetes compared with eating lower amounts, a new analysis of the multinational, multiethnic Prospective Urban Rural Epidemiology (PURE) study suggests.

In addition, the results show that those living in South Asian countries ate the most white rice and subsequently had the highest likelihood of developing type 2 diabetes.

Compared with participants who ate less than 1 cup/day (150 g/day) of cooked white rice, those who ate more than 3 cups/day (> 450 g/day) had a 20% higher risk of developing diabetes over a mean follow-up of 9.5 years (P = .003).

However, among South Asian participants, who consumed a median of 630 g/day of white rice, the risk of diabetes was 61% higher compared to those who consumed less than 150 g/day (P = .02), Balaji Bhavadharini, MD, McMaster University, Hamilton, Ontario, Canada, and colleagues report in their article, published online in Diabetes Care.

As the authors point it, excess white rice consumption, in particular, is known to lead to postprandial glucose spikes. These spikes, in turn, trigger compensatory hyperinsulinemia to help maintain euglycemia.

"Over time, -cells become exhausted, leading to -cell failure and diabetes," the researchers write.

"Among people of middle and lower socioeconomic status, rice consumption is very high because other food choices meat, fish, chicken, vegetables, and fruits are all quite expensive," second author Viswanathan Mohan, MD, PhD, DSc, chairand chief diabetologist at Dr. Mohan's Diabetes Specialties Centre, India, told Medscape Medical News in an email.

"Hence, people make up the calories [they need] by eating 'polished' rice. What we are suggesting is that protein intake should be increased, and this can come...in the form of beans and legumes, whichif consumed along with the rice, would help reduce the overall glycemic load of the diet," he added.

A total of 132,373 participants aged 35 to 70 from 21 different countries were included in the new analysis, which excluded anyone with diabetes at baseline.

Cooked white rice consumption was categorized as less than 1 cup (< 150 g/day); 1 to 2 cups (150 to < 300 g/day); 2 to 3 cups (300to < 450 g/day), or more than 3 cups/day (> 450 g/day). In the overall cohort, the median consumption of white rice was 128 g/day.

Participants from South East Asia (Indonesia, Malaysia, Thailand, Vietnam, and Cambodia, among other countries) ate a median of 239 g/day of white rice, while those from China ate a median of 200 g/day, investigators note.

Those living in South Asian countries (including India, Pakistan, Bangladesh, Nepal, Bhutan, Sri Lanka and the Maldives) ate the most white rice, at a median of 630 g/day.

During the study interval, 6129 individuals developed incident diabetes.

Among those living in South East Asia, the Middle East, South America, North America, Europe, and Africa, the risk of diabetes was 41% higher among those with the highest levels of white rice consumption compared to those with the lowest levels(P = .01), the investigators report.

And as already noted, the risk was even higher, at > 60%, in those living in South Asia.

In contrast, the effect of consuming the greatest quantity of white rice versus the lowest on diabetes risk was minimal among Chinese participants and did not reach statistical significance, the authors note.

"There could be several reasons for this," Mohan said. "Firstly, the actual intake of white rice in China was substantially lower than it was in other countries, especially among those living in South Asia. Secondly, the type of rice the Chinese consume may be slightly different than elsewhere in that it is 'sticky,'" he speculated.

Probably more importantly, however, "in China, they do consume a lot of animal protein as well as vegetable protein," he noted.

In contrast, protein intake tends to be low and carbohydrate intake mostly in the form of white rice is higher in South Asia than in any other region of the world.

In fact, in South Asia white rice makes up 70% to 75% of a typical person's daily calorie intake, Mohan observed.

As the authors point out, until a few decades ago, most of the rice consumed in India was pounded by hand, or "unpolished," and thus was a much coarser grain, similar to brown rice. But this fell out of favor because it's easier to store highly polished white rice than brown rice, which turns rancid more quickly.

In addition, there were only a handful of rice mills in India until the early 1970s, a situation which has now completely changed: there are now over a million rice mills in the country.

"This naturally led to increased consumption of high polished white rice," Mohan emphasized, "and in general, people like the color, taste, and smell of white rice better [than brown rice] plus brown rice takes longer to cook and is difficult to chew," he noted.

The solution to this public health conundrum is multifold. As Mohan sees it, the most obvious solution is to reintroduce brown rice as a widespread food commodity and make it less expensive than white rice.

Alternatively, food manufacturers could develop healthier varieties of white rice with resistant starch that would lower both the glycemic index and overall glycemic load, he observed.

People also need to be encouraged to increase their intake of beans, legumes, and other types of vegetable proteinsor pulses, which in India include chickpeas, green gram, black gram, and thoor dal. When these are consumed along with white rice, it improves the overall quality of the diet and would be expected to reduce the risk of diabetes.

Lastly, people need to be encouraged to be more physically active, which would also help reduce obesity rates and with it, diabetes risk, Mohan emphasized.

The study was funded by a number of pharmaceutical companies including AstraZeneca, Sanofi, Boehringer Ingelheim, Servier, and GlaxoSmithKline.

Bhavadharini and Mohan have reported no relevant financial relationships.

Diabetes Care. Published online September 1, 2020. Abstract

For more diabetes and endocrinology news, follow us on Twitter and Facebook.

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More Proof That High White Rice Intake Ups Type 2 Diabetes Risk - Medscape

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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Why your blood sugar is high in the morning and how to lower it - Insider - INSIDER

The global Millimeter Wave Diabetes Treatment Devices market is segregated on the basis of Type as Under 50 GHz and Above 50 GHz. Based on Application the global Millimeter Wave Diabetes Treatment Devices market is segmented in Type 1 Diabetes and Type 2 Diabetes.

The global Millimeter Wave Diabetes Treatment Devices market report scope includes detailed study covering underlying factors influencing the industry trends.

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The global Millimeter Wave Diabetes Treatment Devices market report provides geographic analysis covering regions, such as North America, Europe, Asia-Pacific, and Rest of the World. The Millimeter Wave Diabetes Treatment Devices market for each region is further segmented for major countries including the U.S., Canada, Germany, the U.K., France, Italy, China, India, Japan, Brazil, South Africa, and others.

Competitive Rivalry

Zimmer MedizinSysteme, Smiths Group, Domer Laser, Hubei YJT Technology and others are among the major players in the global Millimeter Wave Diabetes Treatment Devices market. The companies are involved in several growth and expansion strategies to gain a competitive advantage. Industry participants also follow value chain integration with business operations in multiple stages of the value chain.

The Millimeter Wave Diabetes Treatment Devices Market has been segmented as below:

Millimeter Wave Diabetes Treatment Devices Market, By Type

Millimeter Wave Diabetes Treatment Devices Market, By Application

Millimeter Wave Diabetes Treatment Devices Market, By Region

Millimeter Wave Diabetes Treatment Devices Market, By Company

The report covers:

Report Scope:

The report covers analysis on regional and country level market dynamics. The scope also covers competitive overview providing company market shares along with company profiles for major revenue contributing companies.

The report scope includes detailed competitive outlook covering market shares and profiles key participants in the global Millimeter Wave Diabetes Treatment Devices market share. Major industry players with significant revenue share include Zimmer MedizinSysteme, Smiths Group, Domer Laser, Hubei YJT Technology, Application C10, Application B10, Application B8, Application B9, Application B10, Application C10, and others.

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ThursdaySep24,2020at11:08AM

DURHAM The University of New Hampshire announced it will receive $1.8 million from the National Institutes of Health to further molecular research to better understand drug interactions at the cellular level and help lead to the development of new targeted drugs to treat wide-spread metabolic, growth, neurological and visual disorders including diabetes and cancer.

"This is an exciting opportunity to support some of our preliminary research that showed promise in new protein drug targets involved in several diseases," said Harish Vashisth, associate professor of chemical engineering and recipient of the NIHs Outstanding Investigator award. "The NIH MIRA award (Maximizing Investigators' Research Award) is meant to provide flexibility to investigators and will allow us to explore new ideas and change direction based on our findings during the process."

Vashisth and his team will use computational techniques combined with experimental data to explore new and more suitable stages in the signaling cycle of a cell protein to target drug interventions. One of the studies will focus on better understanding the folding and binding mechanisms of novel peptides, a short string of amino acids that are building blocks of proteins and perform biological functions. Researchers will look at how they affect cell surface receptor proteins, part of the tyrosine kinase family, to signal responses within the cell. Small peptides can fold and bind to the receptor and mimic the normal physiological effects of natural peptides. The goal is to understand the folding and binding and ultimately find drugs to work around the fold.

"Imagine a cell as a flexible bag with the outer surface as the cell membrane containing proteins that act as gate keepers to communicate, or sense, specific conditions outside the cell that in turn trigger a cascade of signaling inside the cell," said Vashisth.

Their second research project will take an unconventional approach to target protein-protein interactions in proteins inside the cell, part of the G-protein coupled receptor family, that are important in touch, smell and sight and are implicated in many diseases. This work would create new small molecule drugs that would cross inside the membrane rather than bind to an outside receptor. These drugs would be synthetic and not naturally occurring.

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UNH receives $1.8 million for biomolecular research in diabetes and cancer - Seacoastonline.com

The scientists concluded that HIIT can help in improving the blood sugar levels and can also help in losing weight effectively.

Representational image. Reuters

Diabetes is one of the major health burdens in the entire world. According to the International Diabetes Federation, more than 463 million adults in the age group of 20 to 79 years were living with diabetes in the year 2019.

Among these, a majority of people have been reported to have type 2 diabetes. Type 2 diabetes is the result of reduced insulin sensitivity in the body, which mostly occurs due to excess body weight and physical inactivity.

It is already known that physical activity helps in managing and preventing type 2 diabetes. However, it has been reported that most commonly practised aerobic exercises such as walking or jogging provide only 10 percent to 20 percent improvement in insulin sensitivity.

As per the new study, presented at the annual meeting of the European Association for the Study of Diabetes (EASD) in September 2020, it was stated that insulin sensitivity, body composition and cardiorespiratory systems of people with obesity along with type 2 diabetes can be improved by combining high-intensity interval training (HIIT) with cycling and rowing.

Determining the effect of HIIT on obese and diabetic people

To determine the effects of HIIT, scientists from the Steno Diabetes Centre Odense, Odense, Denmark, enrolled 48 men in the study and divided them into three groups.

Out of the 48, 15 participants were obese with an average Body Mass Index (BMI) of 31 (kg/m2) and had been diagnosed with type 2 diabetes. The other two groups had non-diabetic participants, out of which 15 were obese with an average BMI of 31 and the rest 18 were lean with an average BMI of 24.

Body mass index, also known as BMI, is a way to measure whether or not a person is overweight or obese. An adult with a BMI that is between 18.5 and 24.9 is considered healthy, between 25 and 29.9 is considered overweight and 30 or over is considered obese.

All the participants underwent a highly supervised HIIT programme, which lasted for eight weeks. The participants had three training sessions per week, which were combined with cycling and rowing.

The effects of the training programme were evaluated with the help of Dual-energy X-ray absorptiometry (DXA) scans to determine the body changes, VO2 max tests to measure the amount of oxygen utilised during the session and euglycemic-hyperinsulinemic clamps along with indirect calorimetry to determine insulin sensitivity and metabolism.

The results of the study

In the beginning, people with diabetes showed around 35 to 37 percent reduction in insulin sensitivity as compared with the non-diabetic subjects.

However, after eight weeks of HIIT, the insulin sensitivity in lean men and those with only obesity was 32 to 37 percent on average whereas the average for the diabetic group was found to be 44 percent.

The scientists further found that after the training, the fasting blood sugar levels in patients with type 2 diabetes were also reduced. The HbA1c results, which measures the average level of blood sugar over the past 2 to 3 months, also showed a decline.

The body fat mass was reduced by 1.6 to 2.3kg in all three groups.

The VO2max results showed that oxygen utilisation increased by 10 percent in lean and obese people with no diabetes, while it increased to 15 percent in people with type 2 diabetes.

The scientists concluded that HIIT can help in improving the blood sugar levels and can also help in losing weight effectively. It is believed that the short bursts of intense anaerobic exercise with short recovery periods in between may prove to be better for people with obesity and diabetes in managing their condition.

For more information, read our article on High-Intensity Interval Training (HIIT).

Health articles in Firstpost are written by myUpchar.com, Indias first and biggest resource for verified medical information. At myUpchar, researchers and journalists work with doctors to bring you information on all things health.

Excerpt from:
HIIT along with rowing and cycling can help type 2 d..etes patients lose weight, improve insulin sensitivity - Firstpost

Why does diabetes make people particularly vulnerable to COVID-19? There is no persuasive evidence that this is because they are more likely to catch the virus in the first place and we, as yet, have no answers. Research is underway to understand the biological reasons why diabetes might allow the virus to get a firmer hold. A pro-inflammatory state, vascular damage, and upregulation of ACE2 receptors, all of which are associated with diabetes, have been suggested as potential contributors to severe COVID-19 in people with the condition7. The type of basic science needed to explore the virus mechanisms of attack and its interplay with diabetes takes time and is vital for understanding how we might better protect and care for people living with the condition.

Recently emerging is some limited and anecdotal evidence that COVID-19 might be triggering new cases of type 1 diabetes, accelerated progression of type 2 diabetes, or a new type of diabetes altogether. Again, we need to look to science for answers only long-term studies will reveal whats really going on and, crucially, help to inform care. To find answers, a global database of new cases of diabetes in patients with COVID-19, called the CoviDiab Registry Project, has been established8. The Post-HOSPitalisation COVID-19 (PHOSP COVID) study, a national consortium to understand and improve long-term health outcomes in people who have had the virus, will also shed light on the long-term implications of COVID-19 for people with diabetes.

Investment in science has never been more important. Last year, UK charities, including Diabetes UK, invested 1.9 billion into medical research more than half of all public spending nationally. But the sector is facing a dramatic and deeply concerning drop in income due to COVID-19 and research is at risk. The Association of Medical Research Charities (AMRC) has predicted a 310 million shortfall in research spend in 2020/21, with an estimated four-year recovery period.

AMRC and its members, including Diabetes UK, are urging the Government to commit to the Life Sciences Charity Partnership Fund (support at #Researchatrisk) co-investment scheme. This will allow medical research charities to emerge from this pandemic intact and in a strong position to continue to fund research that transforms healthcare and saves lives. Now more than ever, investment is needed in the sector to mitigate the impact of COVID-19 and future pandemics, on the health of the nation.

References

1 International Diabetes Federation, (2019). IDF Diabetes Atlas, 9th edn.Brussels, Belgium: IDF. Available at: https://www.diabetesatlas.org

2 Estimated from NCVIN (2016), Diabetes Prevalence Model for England + estimated growth between 20152020 from APHO (2010) Prevalence Models for Scotland and Wales.

3 Barron, E., Bakhai, C., Kar, P., Weaver, A., Bradley, D., Ismail, H., Knighton, P., Holman, N., Khunti, K., Sattar, N. and Wareham, N.J., (2020). Associations of type 1 and type 2 diabetes with COVID-19-related mortality in England: a whole-population study. The Lancet Diabetes & Endocrinology.

4 Diabetes Prevalence Model. Quality and Outcomes Framework (QOF) 2017/18. Public Health England. Available at: https://fingertips.phe.org.uk/profile/diabetes-ft/data

5 Holman, N., Knighton, P., Kar, P., OKeefe, J., Curley, M., Weaver, A., Barron, E., Bakhai, C., Khunti, K., Wareham, N.J. and Sattar, N., (2020). Risk factors for COVID-19-related mortality in people with type 1 and type 2 diabetes in England: a population-based cohort study. The Lancet Diabetes & Endocrinology.

6 Williamson, E.J., Walker, A.J., Bhaskaran, K., Bacon, S., Bates, C., Morton, C.E., Curtis, H.J., Mehrkar, A., Evans, D., Inglesby, P. and Cockburn, J., (2020). OpenSAFELY: factors associated with COVID-19 death in 17 million patients. Nature.

7 Apicella, M., Campopiano, M. C., Mantuano, M., Mazoni, L., Coppelli, A., & Del Prato, S. (2020). COVID-19 in people with diabetes: understanding the reasons for worse outcomes. The Lancet Diabetes & Endocrinology.

8 Rubino, F., Amiel, S. A., Zimmet, P., Alberti, G., Bornstein, S., Eckel, R. H., & Del Prato, S. (2020). New-Onset Diabetes in Covid-19. New England Journal of Medicine.

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COVID-19 and diabetes: What do we (not) know? - Open Access Government

The research and analysis conducted in Peripheral Neuropathy report help clients to predict investment in an emerging market, expansion of market share, or success of a new product with the help of global market research analysis. This report has been designed in such a way that it provides a very evident understanding of the business environment and Peripheral Neuropathy industry. However, this global market research report unravels many business problems very quickly and easily. Due to high demand and the value of market research for the success of different sectors, Peripheral Neuropathy Market report is provided that covers many work areas.

For the basic understanding of strategy in this report, we will focus on the static and dynamic pillars of the industry. Beyond this, identify the business development circle and opportunities. It also focuses on the limitations of analyzing problems in existing business strategies. Focus on various aspects such as application areas, platforms, and key players operating around the world.

Peripheral neuropathy market is expected to gain market growth in the forecast period of 2020 to 2027. Data Bridge Market Research analyses the market is growing at a healthy CAGR in the above-mentioned research forecast period. Emerging markets and vulnerable diabetic patients worldwideare the factors responsible for the growth of this market.

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Major Key Players Mentioned:

Teikoku Pharma USA, Inc, Sun Pharmaceutical Industries Ltd, Galen Limited, Cipher Pharmaceuticals Inc, Mylan N.V., Aurobindo Pharma,ZydusCadila, Hikma Pharmaceuticals PLC, ACI Limited, Apotex Inc, Johnson & Johnson Services, Inc, Pfizer Inc, Arbor Pharmaceuticals, ALMATICA PHARMA, Alkem Labs, Amneal Pharmaceuticals LLC, Novartis AG, and Lupin, among others.

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COVID-19 Impact Analysis:

The report seeks to track the evolution of the market growth pathways and publish a medical crisis in an exclusive section publishing an analysis of the impact of COVID-19 on the Peripheral Neuropathy market. The new analysis on COVID-19 pandemic provides a clear assessment of the impact on the Peripheral Neuropathy market and the expected volatility of the market during the forecast period. Various factors that can affect the general dynamics of the Peripheral Neuropathy market during the forecast period (2020-2026), including current trends, growth opportunities, limiting factors, etc., are discussed in detail in this market research.

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Table Of Contents

Part 01: Executive Summary

Part 02: Scope of the Report

Part 03: Research Methodology

Part 04: Market Landscape

Part 05: Pipeline Analysis

Part 06: Market Sizing

Part 07: Five Forces Analysis

Part 08: Market Segmentation

Part 09: Customer Landscape

Part 10: Regional Landscape

Part 11: Decision Framework

Part 12: Drivers and Challenges

Part 13: Market Trends

Part 14: Vendor Landscape

Part 15: Vendor Analysis

Part 16: Appendix

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Peripheral Neuropathy Market Understand The Key Growth Drivers Developments And Innovations - The Daily Chronicle

During a Case Based Peer Perspective event, Alicia K. Morgans, MD, MPH, associate professor of Medicine, Hematology and Oncology, at the Feinberg School of Medicine, Northwestern University in Chicago, IL, discussed the case of a 75-year-old male with metastatic castration-resistant prostate cancer (mCRPC).

Targeted Oncology: What are potential treatment options for the second-line setting in patients with metastatic castration-resistant prostate cancer (mCRPC)?

MORGANS: This patient was started on enzalutamide [Xtandi] and had progression after 8 months; he was started on docetaxel at that time. He received 4 cycles but had neuropathy that resulted in the patient and provider stopping the treatment.

The patient had a rising PSA level and required treatment. We know that we have multiple treatment options in this second-line setting for mCRPC.

We have to consider what these patients were treated with prior to seeing us. This includes assessing the fitness of the patient and the patients goals and preferences. We now know that this patient was treated with enzalutamide. We also know that the options are abiraterone acetate [Zytiga], cabazitaxel [Jevtana], and docetaxel.

After 4 cycles, the patient experienced neuropathy and a rising PSA level after less than 12 months on treatment.

Would you give cabazitaxel to a patient after experiencing neuropathy from docetaxel?

That would be a good treatment option.

We have data from a study in patients with mCRPC called FIRSTANA [NCT01308567].1 Patients were randomized in the first-line setting in mCRPC to receive either cabazitaxel 25 mg/m2, cabazitaxel 20 mg/m2, or docetaxel 75 mg/m2. For cabazitaxel, the 20-mg/m2 dose replaced the 25-mg/m2 dose in the NCCN [National Comprehensive Cancer Network] guidelines in the United States.2

Although none of these agents demonstrated superiority in terms of disease control or efficacy, there was a slightly higher response observed in the cabazitaxel 25-mg/m2 dose versus the 20-mg/m2 dose. Fewer adverse events [AEs] such as neuropathy, neutropenia, and neutropenic fever were observed in patients who received 20 mg/m2 versus docetaxel, which was a little surprising to me.

The study came out just a few years after cabazitaxel was approved.3 In most cases, I start at the 20-mg/m2 dose rather than the 25 mg/m2. We can give this in patients who have had complications with docetaxel. Its on a cycle-by-cycle basis, but it seems reasonable based on these data and on personal experience. I thought this was an interesting postapproval study that was required of the organization to enlighten us about different doses.

There is also the phase 4 CARD study [NCT02485691], which was shared at the ESMO [European Society of Medical Oncology] Congress last year.4 These patients had already progressed on their AR [androgen receptor]targeted agent and docetaxel. This is a European study, so patients had received an AR-targeted agent in the metastatic castration-resistant setting as well as chemotherapy in the metastatic castration-resistant setting. They were not patients who received AR-targeted agents in the hormone-sensitive setting.

Patients were randomized for their next treatment to cabazitaxel at the full 25-mg/m2 dose with Neulasta [pegfilgrastim versus either abiraterone or enzalutamide, depending on which agent that they had not previously received and progressed on in an earlier phase of the disease. Radiographic progression-free survival [rPFS] was the primary end point, overall survival was a secondary end point, as well as quality-of-life concerns including pain and PSA responses.

The baseline characteristics suggested that there were more patients who were older in the cabazitaxel arm. The investigators reported that patients in the AR-targeted arm experienced pain more frequently, but overall, both arms were fairly well matched. This was a small study to begin with, but they matched well overall

Please explain the efficacy of the CARD trial.

We saw that the rPFS was significantly better for patients who received cabazitaxel versus those treated with either abiraterone or enzalutamide. The median rPFS for the cabazitaxel arm was 8.0 months versus the abiraterone or enzalutamide arm at 3.7 months [HR, 0.54; 95% CI, 0.40-0.73; P <.0001]. Subgroup analysis revealed that most subgroups benefited from an rPFS standpoint.

The overall survival data were also presented at ESMO, and this is why I think it was considered one of the presidential symposia. Patients treated with cabazitaxel had a significant improvement in mortality as compared with patients who received either abiraterone or enzalutamide.

There was a 46% reduction in mortality when patients were treated with cabazitaxel compared with the other 2 regimens. Although this is a higher dose than what I normally prescribe, these patients were still able to tolerate it and had an improved survival.

Interestingly, there were significantly more PSA responses reported with treatment with cabazitaxel versus an AR-targeted agent, and significantly more tumor responses [reported] by [the] RECIST [trial]. When investigators measured the tumor size, it seemed to have decreased in size, and a much better pain response was observed. This was determined by using the percentage of the patients who had an improvement in their pain score that was maintained and clinically meaningful over time. Better pain control with cabazitaxel was reported as well. Investigators also observed a longer time to symptomatic skeletal events in the cabazitaxel arm versus the AR-targeted agent.

Whats important to note is when looking at chemotherapy versus AR-targeted agents, there were more AEs that led to treatment discontinuation, with slightly more discontinuations in the cabazitaxel arm. What surprised me and a fair number of people was that there were more AEs leading to death in those patients treated with the AR-targeted agents than with the chemotherapy. This suggests more mortality-related AEs associated with the AR-targeted agents.

Health-related quality of life seemed to be maintained, probably because the disease was better controlled. This was just presented at the 2020 Genitourinary Cancers Symposium. Patients had better pain control and certainly better prostate-specific concerns with cabazitaxel than with the AR-targeted agents, at least through cycle 5 or so.

What other presentations at the 2019 ESMO Congress were noteworthy?

The other study that I think was groundbreaking at ESMO was a phase 3 trial that targeted DNA repair defects.6 PROfound [NCT02987543] evaluated patients with mCRPC who had also progressed on the AR-targeted agents as well as chemotherapy. They were randomized to receive olaparib [Lynparza] or the second AR-targeted agent. All patients had to have DNA repair defects in their tissue to get into this trial. This was an ambitious study to carry out in a population with prostate cancer. The investigators were able to complete it and do a nice phase 3 trial and present it.

When the 2 arms were compared, the rate of AEs was higher in the olaparib arm; those included cytopenias, some nausea, and other complications. Those are some of the common AEs. Importantly, the treatment duration was significantly longer for patients treated with olaparib than AR-targeted agents.

Reviewing the disease response, rPFS as determined by a blinded independent reviewer was significantly longer for patients treated with olaparib compared with patients who received that second AR-targeted agent. Importantly, patients who received that second AR-targeted agent did not have any restrictions on how long they had to have been on that agent in the first place.

This differs from the CARD study, in which patients had to be on treatment for 12 months or less with a response to an AR-targeted agent. These patients, in contrast, could have been on for however long they were responding; they just had to have received treatment in the past. We see at 3.5 months, 50% of patients treated with that second AR-targeted agent are falling off for radiographic progression, which demonstrates that its not an effective treatment. In any event, olapaolaparib seemed to be significantly more effective in terms of rPFS.

Looking at the confirmed overall response rate in cohort A, which included patients with BRCA1/2 and ATM mutations, there was a significant improvement in objective response rate, 33% versus 2.3% [odds ratio, 20.86; 95% CI, 4.18-379.18; P <.0001].

Reviewing the data for cohort B, which included patients with DNA repair-defect mutations and not just BRCA1/2 or ATM mutations, the investigators reported an improvement in rPFS for this selected patient population.

What did the patient end up receiving?

In this particular case, the patient received cabazitaxel. In a pandemic, I think its especially important to try to prevent our patients from being hospitalized for neutropenic fever.

References:

1. Oudard S, Fizazi K, Sengelv L, et al. Cabazitaxel versus docetaxel as first-line therapy for patients with metastatic castration-resistant prostate cancer: a randomized phase III trial-FIRSTANA. J Clin Oncol. 2017;35(28):31893197. doi:10.1200/ JCO.2016.72.1068

2. NCCN. Clinical Practice Guidelines in Oncology. Prostate cancer, version 1.2020. Accessed May 12, 2020. https://www.nccn.org/professionals/physician_gls/pdf/ prostate.pdf

3. FDA approves lower dose of cabazitaxel for prostate cancer. Updated September 14, 2017. Accessed May 12, 2020. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lower-dose-cabazitaxel-prostate-cancer

4. deWit R, Kramer G, Eymard J, et al. CARD: randomized, open-label study of cabazitaxel (cbz) vs abiraterone (abi) or enzalutamide (enz) in metastatic castration-resistant prostate cancer (mcrpc). Ann Oncol. 2019;30(suppl 5):v851-v934. doi:10.1093/annonc/mdz394

5. Fizazi K, Kramer G, Eymard J-C, et al. Pain response and health-related quality of life (HRQL) analysis in patients with metastatic castration-resistant prostate cancer (mCRPC) receiving cabazitaxel (CBZ) versus abiraterone or enzalutamide in the CARD study. J Clin Oncol. 2020;38(suppl 6):16. doi:10.1200/JCO.2020.38.6_suppl.16

6. Hussain M. PROFOUND: phase 3 study of olaparib versus enzalutamide or abiraterone for metastatic castration-resistant prostate cancer (mcrpc) with homologous recombination repair (hrr) gene alterations. Ann Oncol. 2019;30(suppl 5):v851- v934. doi:10.1093/annonc/mdz394

Link:
Morgans Addresses Neuropathic Toxicity in Second-Line Metastatic CRPC - Targeted Oncology

LA JOLLA - MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ: MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced positive clinical findings published in Cancer Chemotherapy and Pharmacology regarding MN-166 (ibudilast) as a treatment for prevention of chemotherapy-induced peripheral neuropathy (CIPN).

The publication, entitled 'Ibudilast for prevention of oxaliplatin-induced acute neurotoxicity: a pilot study assessing preliminary efficacy, tolerability, and pharmacokinetic interactions in patients with metastatic gastrointestinal cancer', is the result of a collaborative effort between MediciNova and Dr. Janette Vardy, Professor of Cancer Medicine, University of Sydney Concord Cancer Centre in Australia. The authors report that co-administration of MN-166 (ibudilast) with oxaliplatin resulted in improvement or stabilization of oxaliplatin-induced neurotoxicity in the majority of participants treated with oxaliplatin.

This prospective, open-label, sequential crossover study was conducted to assess whether MN-166 (ibudilast) can reduce acute peripheral neuropathy symptoms in patients with metastatic upper gastrointestinal or colorectal cancer. A total 16 patients consented, and 14 patients completed two cycles of oxaliplatin-containing chemotherapy, one cycle with conventional chemotherapy (Cycle A) and one cycle of chemotherapy with concurrent MN-166 treatment (Cycle B). As a cross-over design, each participant acted as their own control. Participants underwent a number of assessments for neurotoxicity on Day 3 of each cycle, and at the completion of each cycle, including the Oxaliplatin-Specific Neurotoxicity Scale (OSNS), the Total Neuropathy Score Clinical (TNSc), the Functional Assessment of Cancer Therapy/Gynaecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx13), and the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) neuropathy subscale.

About Chemotherapy-induced Peripheral Neuropathy

Peripheral neuropathy is a set of symptoms caused by damage to the nerves that are outside of the brain and spinal cord. These distant nerves are called peripheral nerves. Some of the chemotherapy and other drugs used to treat cancer can damage peripheral nerves that carry sensations to the hands and feet. This damage results in chemotherapy-induced peripheral neuropathy (CIPN) and is a common side effect of cancer chemotherapy. Most commonly, people complain of 'pins and needles' in their toes and fingers. CIPN may affect cancer outcomes due to reductions in chemotherapy dosing and/or premature treatment discontinuation and have a profound impact on quality of life and survivorship. According to a meta-analysis which included more than 4,000 patients, CIPN prevalence was 68% when measured in the first month after chemotherapy, 60% at 3 months, and 30% at 6 months or more (Seretny et al., 2014). Long-term neurotoxicity is an important issue for the growing number of cancer survivors, with the highest number of affected patients having been treated for breast and/or colon cancer.

About MN-166 (ibudilast)

MN-166 (ibudilast) is a first-in-class, orally bioavailable, small molecule macrophage migration inhibitory factor (MIF) inhibitor and phosphodiesterase (PDE) -4 and -10 inhibitor that suppresses pro-inflammatory cytokines and promotes neurotrophic factors. Our earlier human studies demonstrated significant reductions of serum MIF level after treatment with MN-166 (ibudilast). It also attenuates activated glial cells, which play a major role in certain neurological conditions. MN-166 (ibudilast)'s anti-neuroinflammatory and neuroprotective actions have been demonstrated in preclinical and clinical studies, which provide the rationale for treatment of amyotrophic lateral sclerosis (ALS), progressive multiple sclerosis (MS) and other neurological diseases such as glioblastoma (GBM), and substance abuse/addiction. MediciNova is developing MN-166 for ALS, progressive MS and other neurological conditions such as degenerative cervical myelopathy (DCM), glioblastoma, substance abuse/addiction, and chemotherapy-induced peripheral neuropathy, as well as prevention of acute respiratory distress syndrome (ARDS) caused by COVID-19. MediciNova has a portfolio of patents which covers the use of MN-166 (ibudilast) to treat various diseases including ALS, progressive MS, and drug addiction.

About MediciNova

MediciNova, Inc. is a publicly-traded biopharmaceutical company founded upon developing novel, small-molecule therapeutics for the treatment of diseases with unmet medical needs with a primary commercial focus on the U.S. market. MediciNova's current strategy is to focus on BC-PIV SARS-COV-2 vaccine for COVID-19, MN-166 (ibudilast) for neurological disorders such as progressive multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), degenerative cervical myelopathy (DCM), substance dependence (e.g., alcohol use disorder, methamphetamine dependence, opioid dependence) and glioblastoma (GBM), as well as prevention of acute respiratory distress syndrome (ARDS) caused by COVID-19, and MN-001 (tipelukast) for fibrotic diseases such as nonalcoholic steatohepatitis (NASH) and idiopathic pulmonary fibrosis (IPF). MediciNova's pipeline also includes MN-221 (bedoradrine) and MN-029 (denibulin).

Statements in this press release that are not historical in nature constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding the future development and efficacy of MN-166, MN-001, MN-221, and MN-029. These forward-looking statements may be preceded by, followed by or otherwise include the words 'believes,' 'expects,' 'anticipates,' 'intends,' 'estimates,' 'projects,' 'can,' 'could,' 'may,' 'will,' 'would,' 'considering,' 'planning' or similar expressions. These forward-looking statements involve a number of risks and uncertainties that may cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Factors that may cause actual results or events to differ materially from those expressed or implied by these forward-looking statements include, but are not limited to, risks of obtaining future partner or grant funding for development of MN-166, MN-001, MN-221, and MN-029 and risks of raising sufficient capital when needed to fund MediciNova's operations and contribution to clinical development, risks and uncertainties inherent in clinical trials, including the potential cost, expected timing and risks associated with clinical trials designed to meet FDA guidance and the viability of further development considering these factors, product development and commercialization risks, the uncertainty of whether the results of clinical trials will be predictive of results in later stages of product development, the risk of delays or failure to obtain or maintain regulatory approval, risks associated with the reliance on third parties to sponsor and fund clinical trials, risks regarding intellectual property rights in product candidates and the ability to defend and enforce such intellectual property rights, the risk of failure of the third parties upon whom MediciNova relies to conduct its clinical trials and manufacture its product candidates to perform as expected, the risk of increased cost and delays due to delays in the commencement, enrollment, completion or analysis of clinical trials or significant issues regarding the adequacy of clinical trial designs or the execution of clinical trials, and the timing of expected filings with the regulatory authorities, MediciNova's collaborations with third parties, the availability of funds to complete product development plans and MediciNova's ability to obtain third party funding for programs and raise sufficient capital when needed, and the other risks and uncertainties described in MediciNova's filings with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2019 and its subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Undue reliance should not be placed on these forward-looking statements, which speak only as of the date hereof. MediciNova disclaims any intent or obligation to revise or update these forward-looking statements.

Contact:

Geoff O'Brien

Email: info@medicinova.com

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MediciNova : Announces Positive Clinical Results Regarding MN-166 for Prevention of Chemotherapy-induced Peripheral Neuropathy Published in Cancer...

North America will continue to be the Leading Market for Neuropathic Pain over the Forecast Period (20182026)

According to a recent study conducted by TMR, the global market for neuropathic pain is expected to reflect a CAGR of over XX% during the forecast period (20182026). In 2015, the market was valued at over US$XX Billion and is estimated to stand at US$XX Billion by 2026 end.

This Press Release will help you to understand the Volume, growth with Impacting Trends. Click HERE To get SAMPLE PDF (Including Full TOC, Table & Figures) @https://www.trendsmarketresearch.com/report/sample/3726

Factors such as increasing prevalence of chronic disorders including cancer and diabetes, introduction of newer modalities of receiving neuropathic pain treatment, growing number of pain management service providers and higher demand for neuropathic pain treatment drugs are expected to support the growth of neuropathic pain market globally. Further, arrival of various new medications for neuropathic pain treatment in the market, increasing patient awareness on the availability of advanced neuropathic pain therapeutics and rising demand for generic drugs are additional factors expected to drive the market growth. Moreover, pharmaceutical companies are actively focusing on developing enhanced drugs to cater to the requirement of patients with neuropathic disorders. In contrast to all of that, adverse side effects of steroids and opioids coupled with high cost of branded drugs may act as impediments for the global market of neuropathic pain.

Based on drug class, the global market for neuropathic pain has been segmented into anticonvulsants, tricyclic antidepressant, opioids, local anaesthesia, steroids, and others. Anticonvulsants drug is anticipated to be the largest segment of the market, reflecting a CAGR of over XX% during the forecast period. Minimum risk of side effects is a major factor driving the demand for this segment. By the end of 2026, the segment is estimated surpass market valuation of over US$XX Billion. Tricyclic antidepressant drugs are also gaining popularity amongst the physicians and patients and the segment is expected to witness a sound growth during the forecast period.

By indication, the market has been segmented into chemotherapy induced peripheral neuropathy, diabetic neuropathy, and others. Diabetic Neuropathy segment accounts for the largest share of the market. By the end of 2018, the segment is anticipated to account for nearly 47% share of the market in terms of value. On the other hand, chemotherapy induced peripheral neuropathy indication is projected to account for over 42% share of the market in revenue by 2018 end.

By region, the global market for neuropathic pain has been segmented into Asia Pacific North America, Europe, Latin America and the Middle East & Africa. North America is anticipated to be the most lucrative market for neuropathic pain, account highest share of the market in terms of value. The market in the region is expected to expand at a CAGR of over XX% during the forecast period. This is primarily due to a strong distribution network and presence of advanced healthcare infrastructure and major players of the market in the region.

Pre-Book Right New for Exclusive Analyst Support @https://www.trendsmarketresearch.com/report/analyst/3726

Vendor News

Key players operating in the global market for neuropathic pain include Bristol Myers Squibb, Depomed, Inc., GlaxoSmithKline PLC, Pfizer, Inc., Sanofi S.A., Eli Lily and Company, Baxter Healthcare Corporation, Biogen Idec, and Johnson & Johnson Services, Inc. Most of these pharmaceutical companies are actively focusing on developing enhanced medication for treat neuropathic pain and other disorders in order to strengthen their presence in the global market for neuropathic pain. Global market for neuropathic pain is expected to surpass market valuation of US$XX Billion by the end of 2026

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Neuropathic Pain Market: Projection of Each Major Segment over the Forecast Period 2026 - The Market Records

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 Luk[emailprotected]

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 - PRNewswire

The Warriors are back in the lab and putting up shots in the Warriors Minicamp, presented by Oracle NetSuite. One of those ready to step back on the hardwood and get their reps in is center Kevon Looney. After a 2019-20 campaign in which he appeared in just 20 of the Dubs 65 games due to a combination of neuropathy and abdominal soreness, Looney says he is doing great and ready to test himself.

See what else the Dubs center had to say following Thursdays practice below:

On his recovery from abdominal surgery in May:I had a lot of time to take my time on the rehab and I didnt have to rush this as though we were playing, so I was able to be really detail-oriented about it and make sure I was feeling 100 percent before stepping on the court and before pushing myself this camp is great for me so I have a chance to play (with) these guys, really test myself and see where Im at.

On what helped him through his injuries during the 2019-20 season:Just being in a good atmosphere like the Warriors. Just having the support of the coaches, the training staff and players made a tough time easier. Kinda got down on myself: signed that contract and wanted to come in and have a big year, but things didnt go as planned. To get injured again, and then get injured again, was kinda frustrating I got a lot of trust in our training staff and that theyre going to put me in a position to succeed. I was able to lean on my family, lean on my teammates, lean on fans. I always have my support.

His feelings on current racial inequality and overcoming the obstacles:Its been a tough time seeing what happened to James Blake. Hes not the first, and probably wont be the last its sad to say. Growing up in Milwaukee, seemed like every couple of months or every couple of years something like this happens Gotta try to persevere, gotta try to stay hopeful, try to encourage people to do the right thing, try to get them to protest peacefully, get them to go out there and vote.

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What They Are Saying in The Dubble - 9/24/20 - Warriors.com