Advancing Preclinical Autoimmune Studies &
Accelerated FDA Approvals Producing Rewards in Biotech
Sector
Coral Springs, FL -- September 20, 2016 -- InvestorsHub
NewsWire -- 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 Regens
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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