AVI BioPharma – Results From Phase I Clinical Trials

AVI BioPharma, Inc. (NASDAQ: AVII), a developer of RNA-based therapeutics, today announced positive safety results from all six dose cohorts in the single ascending dose studies of AVI-6002 and AVI-6003, AVI’s lead drug candidates being evaluated for the treatment of Ebola virus and Marburg virus, respectively. 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.

Data from 60 subjects in 12 cohorts from the AVI-6002 and AVI-6003 studies combined were evaluated by an independent Data and Safety Monitoring Board (DSMB), which issued recommendations for both studies to progress as planned to multiple ascending dose studies after no safety concerns were identified. The Phase I single ascending dose trials were designed to characterize the safety, tolerability and pharmacokinetics of each therapeutic candidate in healthy adult volunteers.

“The favorable safety profiles of these two candidates show promise for drugs that utilize our PMOplus(R) chemistry,” said Chris Garabedian, president and CEO of AVI BioPharma. “These data underscore how our chemistry may be safe independent of the sequence that is targeted, which we believe will support applications to other disease targets.”

The Phase I multiple ascending dose studies are planned to characterize the safety, tolerability and pharmacokinetics of multiple doses of AVI-6002 and AVI-6003 in healthy adult volunteers. The randomized, double-blind placebo controlled studies 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-6002 and AVI-6003 are AVI’s lead therapeutic candidates for the Ebola and Marburg viruses, respectively. Both candidates employ AVI’s patented PMOplus(R) technology that selectively introduces positive charges to its phosphorodiamidate morpholino oligomer (PMO) backbone to improve interaction between the drug and its target.

About AVI BioPharma – AVI BioPharma is focused on the discovery and development of novel RNA-based therapeutics for rare and infectious diseases, as well as other select disease targets. Applying pioneering technologies developed and optimized by AVI, the Company is able to target a broad range of diseases and disorders through distinct RNA-based mechanisms of action. Unlike other RNA-based approaches, AVI’s technologies can be used to directly target both messenger RNA (mRNA) and precursor messenger RNA (pre-mRNA) to either down-regulate (inhibit) or up-regulate (promote) the expression of targeted genes or proteins. By leveraging its highly differentiated RNA-based technology platform, AVI has built a pipeline of potentially transformative therapeutic agents, including eteplirsen, which is in clinical development for the treatment of Duchenne muscular dystrophy, and multiple drug candidates that are in clinical development for the treatment of infectious disease.

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Post Written By: Ed Liston Ed Liston is a senior contributing editor at TheStockMarketWatch.com. An active market watcher and investor, Ed guides an independent team of experienced analysts and writes for multiple stock trader publications. He is widely quoted in various financial publications on the Internet. When Ed is not writing about stocks, investing in stocks, talking about stocks, or otherwise doing something stock related, he likes to go sailing and fishing in his yacht.