AVI BioPharma receives $11.5M DTRA fund to develop AVI-7012 for treating Junin virus infection

Oct 5 2009

AVI BioPharma, Inc. (NASDAQ: AVII), a developer of RNA-based drugs, announced today that it has received expanded contract funding of approximately $11.5 million from the Defense Threat Reduction Agency's (DTRA) Transformational Medical Technologies Initiative (TMTI) to support development of the Investigational New Drug (IND) data package for its candidate drug, AVI-7012, to treat Junin virus infection. To date, the United States Department of Defense (DoD) has contracted with AVI for work potentially worth up to $45 million for the development of AVI's RNA-based drug candidates to treat Ebola, Marburg and Junin virus infections (AVI-6002, AVI-6003 and AVI-7012, respectively).

"AVI has recently been able to confirm the impressive and dose-related survival of drug-treated non-human primates in large dose titration studies for Ebola and Marburg virus infections, which were carried out in collaboration with the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID)," said Dr. Patrick Iverson, Senior Vice President for Strategic Alliances at AVI. "Importantly, these studies allowed us to unequivocally demonstrate the sequence-specific nature of the protection afforded by our drug candidates."

AVI has received a 'safe to proceed' allowance from the United States Food and Drug Administration (FDA) for IND applications for clinical safety trials of its two lead products to treat Ebola and Marburg virus infections. These INDs represent the first TMTI supported drug candidates targeting bioterrorism agents to receive FDA IND allowance.

AVI plans to conduct the animal efficacy trials for potential approval of its drugs under the Animal Rule as part of its continued collaboration with USAMRIID. The majority of the collaborative research effort between AVI and USAMRIID has been supported by a research contract from the DoD's TMTI with the goal of developing a new antiviral platform targeting hemorrhagic fever viruses. The current funding is a second amendment and expansion of an original contract from DTRA, which was awarded in November 2006 for $28 million and has been fully authorized. The contract for the first amendment was issued in May 2009 when an additional $5.9 million was authorized to support continued development of AVI's RNA-based drugs AVI-6002 and AVI-6003 to treat Ebola and Marburg virus infections, respectively.

"The expansion of the contract for our therapeutic programs in Junin, Ebola and Marburg viruses reflects the DoD's continued support of our bio-defense program, which is developing a series of RNA-based anti-viral drugs," said David Boyle, Chief Financial Officer of AVI. "AVI's ability to virtually double the value of the original contract is a powerful illustration of the performance of our drug candidates to date."

AVI-6002, AVI-6003 and AVI-7012 are novel analogs based on AVI's PMO antisense chemistry in which anti-viral potency is enhanced by the addition of positively-charged components to the morpholino oligomer backbone.