FirstEver

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First-Ever Positive Phase III Trial in Epidermolysis Bullosa

A topical treatment derived from tree bark significantly increased healing of epidermolysis bullosa (EB) lesions versus standard care in an international multicenter clinical trial.

After 45 days of treatment, 41.3% of patients randomized to oleogel-S10 (Filsuvez) had complete wound closure as compared with 28.9% of the control group. A subgroup analysis showed that the beneficial effects were limited to patients with recessive dystrophic, which accounted for almost 80% of the study population.

The wound-healing advantage of oleogel-S10 emerged at about 30 days and persisted out to 90 days, when the proportion of patients with healing became similar in the two treatment groups, reported Dedee Murrell, MD, of the University of New South Wales in Kensington, Australia, during the European Academy of Dermatology and Venereology virtual conference.

“The time to event, which is wound healing over 90 days … was not statistically significant overall,” she said. “The wound healing trajectories demonstrated that oleogel-S10 accelerates wound healing in a subset of the wounds. However, as expected, with good wound care, the control group begins to catch up later by 90 days. The difference in the proportion of healed target wounds had narrowed between treatment groups at 90 days, but the control group never overtook the oleogel arm.”

“This is the first time that a phase III trial in EB has met its primary endpoint,” she added.

Background of Development

A rare genetic skin-fragility disorder, EB characteristically emerges as a pattern of recurring healing and break-down wounds, along with chronic slow-healing or nonhealing wounds. The condition has no approved therapy, and standard of care consists of nonadhesive bandages, topical antimicrobial agents, topical steroids, and various unapproved therapies that are not specific for EB, Murrell noted.

The primary active ingredient in oleogel-S10 is betulin, a naturally occurring triterpene found in the bark of certain types of birch trees. Dry betulin extract is mixed with sunflower oil to form a gel, which is applied directly to EB lesions and to the contact surface of bandages. The mechanistic rationale for its use in EB includes evidence that triterpenes help modulate inflammation and are involved in keratinocyte proliferation, migration, and differentiation.

Preliminary clinical research provided evidence of accelerated wound healing in patients with dystrophic EB. The work subsequently led to the international phase III EASE trial. Investigators at 58 sites in 28 countries enrolled 223 patients, primarily with dystrophic EB but also junctional EB or Kindler syndrome. Eligible patients had a partial thickness wound 10-50 cm2 in size, persisting for 21 days to 9 months.

Patients were randomized to oleogel-S10 or control gel, each in addition to standard dressings changed at least once every 4 days. The primary endpoint was the proportion of patients who had a first complete closure of a target wound within 45 days. Secondary endpoints included time to wound healing, proportion of target wounds healed within 90 days, incidence and severity of wound infections, change in total body wound burden, change in itching, and adverse events.

Patients ages 4-12 years accounted for

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health

First-Ever Treatment Shown to Reverse Alzheimer’s Earns NeuroEM Therapeutics FDA Breakthrough Device Status

The FDA is expediting a revolutionary clinical-stage head device to beat back Alzheimer’s disease at home

NeuroEM Therapeutics is poised to deliver a knockout blow to Alzheimer’s disease. The clinical-stage medical device company is pleased to announce FDA Breakthrough Device designation for its bioengineered head device shown to reverse Alzheimer’s memory loss in its pilot study, published last fall in the Journal of Alzheimer’s Disease.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201028005376/en/

Woman pictured wearing NeuroEM Therapeutics’ bioengineered MemorEM™ cap and arm control box. This revolutionary head device has earned FDA Breakthrough Device designation, having demonstrated in a pilot study that it can reverse Alzheimer’s disease. This woman’s participation in the study resulted in her regaining the equivalent of 12 months of memory. (Photo: Business Wire)

“No other drug or device has received this highest FDA designation to accelerate a treatment for Alzheimer’s disease,” said Dr. Robert Matthews, PhD, CEO of NeuroEM Therapeutics. “No other treatment has demonstrated the clinical results we have thus far, to not only slow but in fact reverse the progressive, debilitating loss of memory caused by this devastating brain disease.”

The FDA has given Breakthrough status to over 300 devices and over 100 drugs, but none to a therapeutic for Alzheimer’s disease – until now. NeuroEM’s head device (MemorEMTM) is the first-ever Alzheimer’s treatment (device or drug) to receive FDA Breakthrough status. The FDA program is designed to expedite the development and review process of new technology for patients with life-threatening or irreversibly debilitating conditions, such as Alzheimer’s Disease.

  • NeuroEM’s novel, proprietary technology, called Transcranial Electromagnetic Treatment (TEMT), achieves what other treatments for AD have not. In fact, no other therapy comes close to MemorEM’s remarkable results, made possible by its unique modes of action.

  • In just two months of daily use, the MemorEM restored on average the equivalent of 12 months of memory for 7 of 8 participants in its pilot study, none of whom experienced adverse side effects.

  • Treatment is easy, comfortable and safe. A patient wears what appears to be a simple cap that belies the complex biomedical engineering within it. The device is worn twice a day in home for an hour at a time, and its design allows the patient to move around home as usual.

NeuroEM has pioneered TEMT to successfully penetrate the skull to reach vital nerve cells in the brain called neurons. NeuroEM’s revolutionary TEMT technology works by breaking up small aggregates (oligomers) of two toxic proteins, called β-amyloid and tau, that are made inside the brain’s neurons during the Alzheimer’s disease process. These two toxic oligomers appear to be the root cause of Alzheimer’s disease by wreaking havoc on vital functions within neurons – especially in brain areas involved in memory. The electromagnetic waves emanating from multiple emitters within NeuroEM’s MemorEM head device easily penetrate the human brain and gently disassociate the toxic oligomers inside neurons resulting in a reversal of Alzheimer’s memory impairment in key

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health

Beachbody Launches First-Ever Running Program

To run a 5K in 30 days, both English and Spanish customers have innovative “30 Day Breakaway” to learn from a world class trainer

Beachbody, renowned for its innovative fitness and nutrition content streamed on the Beachbody On Demand platform, has launched “30 Day Breakaway” – its first-ever running program that utilizes a combination of strength training and running workouts that can be done outdoors or inside with the goal of getting healthy, fit and actually completing a 5K on day 30.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201026005104/en/

Beachbody Launches First-Ever Running Program, “30 Day Breakaway” (Photo: Business Wire)

Created by Super Trainer and accomplished track-and-field athlete, Idalis Velazquez, “30 Day Breakaway” is designed for both novice and experienced runners alike, with participants following her trademark resistance workouts followed by interval run training with specific training protocols, 3 times a week.

In addition to being Beachbody’s first running centric program, “30 Day Breakaway” is also the company’s first program produced concurrently in Spanish and English thanks to its bilingual instructor.

The program is designed for anyone who wants to experience the joy of running a 5K and feel all of the associated health benefits. With that in mind, Beachbody is encouraging members to run in its first virtual “5k race,” the 30 Day Breakaway Virtual 5K, from November 21 – November 29, to raise funds for Hope of the Valley – a rescue mission dedicated to eliminating poverty, hunger and homelessness in the San Fernando Valley. In addition to funds generated from the virtual event, Beachbody will match up to $500,000. As an added incentive, participants will be eligible to receive a limited-edition 5k race medal when they submit their “30 Day Breakaway” 5k race time and transformation results.

“With people feeling cooped-up at home this year, ‘30 Day Breakaway’ is perfectly timed to give people a new outlet to get healthy and fit,” said Beachbody CEO Carl Daikeler. “I’m proud to be one of the first people to do this program, especially since I’m not a runner, so this is my chance to learn while also doing good within our community. And we’re hoping to maximize the $500,000 match for our charitable partner, Hope of the Valley this November.”

“I’m thrilled to be partnering again with Beachbody to introduce ‘30 Day Breakaway,’” said Idalis Velazquez. “As a NASM-certified personal trainer and creator of Beachbody’s Spanish program Mes de Más, this one-on-one running and resistance program to get you 5K-ready is a dream come true for me.”

“30 Day Breakaway” combines a mix of running and resistance training six days per week for 20 to 45 minutes per day. Different types of running (or walking) workouts use individual rates of perceived exertion (RPE) — from moderate, steady-state efforts to speed work — to help participants to adapt and progress quickly. In the event of inclement weather, a Rainy Day Cardio routine has been created to help participants stay on track.

The main calendar

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