Sarepta therapeutics announces publication of Ebola and Marburg phase I clinical study results in antimicrobial agents and chemotherapy Full Text
Sarepta Therapeutics, 10/17/2014 Sarepta Therapeutics, Inc. (NASDAQ: SRPT), a developer of innovative RNA–based therapeutics, announced the publication of results from two single ascending–dose studies that demonstrated no clinical or toxicologic safety concerns with the company's drug candidates for the treatment of Ebola and Marburg virus, respectively.
EUA ...........this is why it came from left field
PMO-Based Platform Chemistries Used by AVI to Design and Manufacture Novel RNA-Based Drug Candidates Against Both Undisclosed Bacterial and Viral Targets
BOTHELL, WA--(Marketwire - Jun 16, 2011) - AVI BioPharma, Inc. (NASDAQ: AVII), a developer of RNA-based therapeutics, and the Naval Medical Research Center (NMRC) in Silver Spring, MD, today announced the successful completion of a formal rapid-response exercise conducted by the Joint Project Manager Transformational Medical Technologies (JPM-TMT) of the Defense Threat Reduction Agency (DTRA). The exercise involved two undisclosed bacterial and viral threats and exhibited AVI's continued success in the development of a credible rapid response capability utilizing its RNA-based therapeutic technologies against pathogenic threats. Previously, AVI successfully completed its first formal rapid-response exercise against the pandemic H1N1 influenza virus (swine flu) in 2009 and one against the dengue virus in 2010.
The key outcome of this newest rapid response exercise was AVI's simultaneous conception, design and manufacture in 18 days of two novel RNA-based drug candidates, one against a gram negative bacterial target and the second against a viral target. The drug candidates use AVI's proprietary phosphorodiamidate morpholino oligomer (PMO) technologies, including PMOplus™, a positively charged version of its intrinsically charge-neutral PMO chemistry. This exercise is part of JPM-TMT 's and AVI's ongoing research efforts to develop and refine an efficient rapid-response capacity that includes the capability of responding to a real-world emerging infectious disease or biological threat by rapidly identifying the threat, designing and producing therapeutic candidates against the threat, and then evaluating the preclinical efficacy of therapeutic candidates.
"By addressing two pathogenic threats simultaneously, including for the first time a bacterial threat, this exercise further tested AVI's demonstrated ability to
just about any single strand virus ''do a sequence and get the drug made from Sarepta's platform.See rapid response done by us army and Avi/Sarepta
seems like we may see the 52 week high faster than we think....
I think the FDA is just looking for production of dystrophin in a larger group for approval of this drug ,Sarepta has hired a third party for exact measuring ,Natural history has already proven dystrophin production slows the progression of dmd .
So my thinking is after 24 weeks of dosing the FDA will approve the drug here..''confirmation of dystrophin''
For ramp up and production ..It is simply a wise choice.
ebola has a non death rate of of 40 percent in healthy humans and i do not think zmapp is all that ,we will see in the African trials
Oppenheimer Maintains Outperform On Sarepta As 3-Year Data Support Eteplirsen’s Clinical Benefit
October 14, 2014 12:01 PM EDT by Editor Corey Williams in Exclusively Published, Healthcare
In a research report issued Tuesday, Oppenheimer analyst Christopher Marai maintained an Outperform rating on Sarepta Therapeutics (NASDAQ:SRPT) with a $45 price target, as longer term follow-up presented at World Muscle Society (WMS) for SRPT’s eteplirsen’s phase 2b data highlights improved function vs. natural history.
Marai noted, “Newly published nat history data at WMS highlight eteplirsen’s benefit even in the ITT population (including 2 patients who became non-ambulatory). Data demonstrated a clinically meaningful 27-31m benefit (-111m vs -138-142m) (Pane et al.). In the mITT population, the benefit looks significantly better even with recent declines. We continue to expect accelerated approval of eteplirsen given the unmet need, preliminary evidence of efficacy and minimal toxicity that looks better than current standard of care steroids. Recall, a majority of DMD patients receive steroids, that, while not approved, delay disease progression but have side effects.”