Advancing Preclinical Autoimmune Studies & Accelerated FDA Approvals Producing Rewards in Biotech Sector

Sep 20, 2016, 08:30 ET from FN Media Group LLC

CORAL SPRINGS, Florida, September 20, 2016 /PRNewswire/ --

Biotech & Pharma companies aim to create enhanced treatments & therapies for autoimmune diseases such as arthritis, cancer and other rare disease conditions through the latest preclinical studies, seeking accelerated FDA approvals and protocol assessments that include advancements from Sarepta Therapeutics, Inc. (NASDAQ: SRPT), Regen BioPharma Inc. (OTCBB: RGBP), Novavax, Inc. (NASDAQ: NVAX), PTC Therapeutics, Inc. (NASDAQ: PTCT) and Array BioPharma (NASDAQ: ARRY).

Regen BioPharma Inc. (OTCQB: RGBP), (OTCQB: RGBPP) today announced completion of experiments demonstrating immunological effects of its novel NR2F6 small molecule modulators.  These experiments were conducted in collaboration with Dr. Xiaojing Ma, Professor of Microbiology and Immunology at Weill Cornell Medical College. The experiments revealed that administration of Regen's proprietary compounds RG-NA01, RG-NI01 and RG-NI02 prevented cells of the immune system from producing the inflammatory factors interleukin-2, interferon-gamma, tumor necrosis factor-alpha and, importantly, interleukin-17a. These factors are critically involved in the immune response found in autoimmune diseases such as rheumatoid arthritis and psoriasis.

Read the full Regen BioPharma (RGBP) release at:  http://financialnewsmedia.com/profiles/rgbp.html

The company is currently developing small molecule drugs that target NR2F6 and either inhibit production of these factors or, in other cases, stimulate their production. The goal is to have a series of compounds that can modulate the immune system up or down. Regen has recently filed a composition of matter patent application covering these novel NR2F6 small molecule modulators. NR2F6 is a molecular switch which controls genes associated with the immune response.

"We are delighted to discover that our lead compounds have a cellular effect, even though these compounds are not optimized yet," said Harry M. Lander, Ph.D., MBA, President and Chief Scientific Officer of Regen. "These preclinical experiments firmly support our initial screening data which discovered these compounds. Now, it is a matter of optimizing these compounds to improve their efficacy. To date, no one in the world has reported the discovery of molecules, natural or synthetic, which activate or inhibit NR2F6 except Regen." 

In other Biotech performances and developments in the markets this week:   

Sarepta Therapeutics, Inc. (NASDAQ: SRPT), a developer of innovative RNA-targeted therapeutics, yesterday announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for EXONDYS 51™ (eteplirsen) as a once weekly intravenous infusion of 30 milligrams per kilogram for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation in the DMD gene that is amenable to exon 51 skipping. This indication is based on an increase in dystrophin in skeletal muscles observed in some patients treated with EXONDYS 51. A clinical benefit of EXONDYS 51 has not been established. Continued approval for this indication may be contingent upon verification of a clinical benefit in confirmatory trials. The most common adverse reactions compared to a placebo group were vomiting (38%) and balance disorder (38%) with contusion, excoriation, arthralgia, rash, catheter site pain, and upper respiratory tract infection also reported more frequently than placebo (≥ 10%).

Novavax, Inc. (NASDAQ: NVAX) last week announced topline data from two clinical trials of its RSV F-protein recombinant nanoparticle vaccine candidate (RSV F Vaccine) in older adults. The Resolve(TM) trial, a Phase 3 trial of our RSV F Vaccine in 11,856 older adults (60 years of age and older), did not meet the pre-specified primary or the secondary efficacy objectives, and did not demonstrate vaccine efficacy. Consistent with our previous clinical experience, the vaccine was well tolerated.

PTC Therapeutics, Inc. (NASDAQ: PTCT) closed up over 20% on Monday at $10.99 on over 9.1 Million shares traded by the market close. PTC Therapeutics announced last week that on September 8, 2016 it approved non-statutory stock options to purchase an aggregate of 22,900 shares of its common stock to eleven new employees. The awards were made pursuant to the NASDAQ inducement grant exception as a component of our new hires' employment compensation.

Array BioPharma (NASDAQ: ARRY) announced recently that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) related to BEACON CRC, a global Phase 3 trial of encorafenib and Erbitux® (cetuximab), with or without binimetinib, versus standard of care in patients with BRAF-mutant colorectal cancer (CRC) who have previously received first-or second-line systemic therapy.

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