2014

Test Results Show Unprecedented Achievement for Marburg Drug Candidate

Treatment with JPM-TMTFunded AVI-7288 Shows Significant Survival Rates Even When Administered up to Four Days Post Infection 

FORT BELVOIR, Va., Aug. 2, 2012 /PRNewswire-USNewswire/ -- A new study testing a drug candidate to treat Marburg virus demonstrated significant survival rates up to four days after exposure to the disease.   Referred to as AVI-7288, the drug is a post-exposure prophylactic targeting the Marburg virus which may cause hemorrhagic fever, a severe, life-threatening disease that exhibits fever and bleeding.  The development of AVI-7288 is funded by the Department of Defense's (DoD) Joint Program Executive Office for Chemical and Biological Defense, Joint Project Manager Transformational Medical Technologies (JPM-TMT).  Sarepta Therapeutics—formerly AVIBioPharma—conducted the study to determine the efficacy of AVI-7288 when administered at various post-exposure time points. The results demonstrated a high degree of survival, between 83% and 100%, in each of four post-exposure cohorts that received daily treatments with AVI-7288 beginning immediately and then one, two and four days after infection. The placebo-treated control group had a 0% survival rate.

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Working with scientists at the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), Sarepta tested AVI-7288 in a non-human primate model under the U.S. Food and Drug Administration's (FDA) "animal rule".   The FDA requires that when drug testing for efficacy in humans is not feasible or is unethical, an animal model must be used to better understand the disease and to demonstrate drug effectiveness without endangering humans.

"Showing efficacy when used up to four days post infection is a very significant step in the development of the Marburg drug candidate," noted David E. Hough, Joint Project Manager for JPM-TMT. "Our goal is to protect the Warfighter and the nation from naturally occurring or weaponized viruses and this new development means that we may soon be able to offer treatments for a lethal and fast-acting virus even days after the suspected exposure."

The ongoing study will now monitor the group of non-human primates off-treatment through day 40 with analysis of additional indicators such as liver enzymes and renal markers.

Through its Hemorrhagic Fever Virus-Therapeutics Medical Countermeasures acquisition program (HFV-Tx MCM), JPM-TMT is targeting Marburg as a model for testing the development of rapidly adaptable platform-based, post-exposure therapeutics for all HFVs.  John Anderson, the program's product manager, explained that "the continued success of this program will provide platform technologies capable of rapidly responding to outbreaks of all HFVs as well as other biological pathogens."

About Joint Project Manager Transformational Medical Technologies (JPM-TMT)

JPM-TMT, a component of the Joint Program Executive Office for Chemical and Biological Defense, aims to protect the Warfighter from emerging infectious diseases, genetically altered and unknown biological threats. Through strategic investments and partnerships with innovative biotech firms, pharmaceutical corporations, other government agencies, and academic institutions, JPM-TMT facilitates the advanced development and acquisition of broad-spectrum medical countermeasures and systems to enhance our nation's biodefense response capability. For more information, visit www.jpmtmt.mil.

SOURCE Joint Project Manager Transformational Medical Technologies



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