Palm Beach, FL 2/28/12 (StreetBeat) -- AVI BioPharma, Inc. (NASDAQ: AVII), a developer of RNA-based therapeutics, today announced that it has received approval from the Food and Drug Administration (FDA) to proceed with a single oligomer, AVI-7288, in studies in both humans and non-human primates to support the safety and efficacy of post-exposure prophylaxis against Marburg virus infection. AVI-7288 is one of two components that make up AVI-6003. Studies conducted to date have shown that efficacy in non-human primates can be attributed to this single component, while the second component, AVI-7287, does not appear to contribute to efficacy. AVI is conducting this work under a Department of Defense contract managed by the Joint Project Manager Transformational Medical Technologies (JPM-TMT) Project Management Office, a component of the Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD). The FDA approved proceeding with the Marburg program using the single oligomer AVI-7288 under the original IND."While we have not seen any toxicity in humans to date with AVI-6003, by removing AVI-7287 we have a simpler development path and may improve the therapeutic window by evaluating a single action agent," said Chris Garabedian, president and CEO of AVI BioPharma. "We are pleased to be able to explore this single oligomer as a potentially safe and effective treatment against this lethal hemorrhagic fever virus."
AVI will proceed with dosing AVI-7288 in the Phase I multiple ascending dose studies planned to characterize the safety, tolerability and pharmacokinetics of multiple doses of the drug in healthy adult volunteers. The randomized, double-blind placebo controlled study will be overseen by a DSMB, who will review safety and clinical laboratory data after each dose cohort prior to enrolling the next highest dose cohort. AVI will also proceed using AVI-7288 in non-human primate studies to continue to evaluate efficacy.
Patrick Iversen, Ph.D., Senior Vice President of Research and Innovation at AVI, will present the results of a non-human primate confirmatory study conducted to evaluate the optimal dose and components of AVI-6003 during the upcoming Association of Microbiology BioDefense and Emerging Diseases Research Meeting in Washington, DC. In the confirmatory study at higher doses of PMOplus® at 15 mg/kg/component, survival was 90%, 100% and 0% in the AVI-6003, AVI-7288 and placebo groups, respectively. Based on these results, AVI concluded that AVI-7288 is the active component in AVI-6003 and that further development would proceed accordingly with the single oligomer component AVI-7288. The presentation is titled "A Single PMOplus® Oligomer is Effective in a Cynomolgus Macaque Marburg Virus Lethal Challenge Model" and will be presented at 3:20 p.m. EST on Tuesday, February 28, 2012, during session 020/Therapeutics.
Dr. Iversen will also deliver a poster presentation titled "Restoring Antibiotic Sensitivity with Antisense Inhibitors of Gene Expression" at 1:00 p.m. EST on Tuesday, February 28, 2012, during poster session 018.
The presentation and poster will be posted on the AVI BioPharma website in the "Events & Presentations" section after the respective sessions are completed. The presentation and poster will be archived there following the presentation for 90 days.
AVI-7288 is a single oligomer, one of two composing AVI-6003. AVI-7288 employs AVI's patented PMOplus® technology that selectively introduces positive charges to its phosphorodiamidate morpholino oligomer (PMO) backbone to improve interaction between the drug and its target.
AVI-6003 has been AVI's lead therapeutic candidate to-date for the Marburg virus and is a combination of AVI-7287 and AVI-7288, both of which employ AVI's patented PMOplus® technology.
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