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news.AVI BioPharma has reported the positive safety results from all six dose cohorts in the single ascending dose studies of its AVI-6002 and AVI-6003, being investigated for the treatment of Ebola virus and Marburg virus, respectively.
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The Phase I single ascending dose trials were intended to evaluate the safety, tolerability and pharmacokinetics of each therapeutic candidate in healthy adult volunteers.
The company is conducting the study in collaboration with Department of Defense contract managed by the Joint Project Manager Transformational Medical Technologies (JPM-TMT) Project Management Office.
AVI BioPharma president and CEO Chris Garabedian said the favorable safety profiles of these two candidates show promise for drugs that utilize the company’s PMOplus technology.
The PMOplus will specifically enhance drug performance characteristics by targeting cell penetration and maintaining antiviral performance.
The data from the AVI-6002 and AVI-6003 studies were evaluated by an independent Data and Safety Monitoring Board (DSMB), which will review safety and clinical laboratory data after each dose cohort before enrolling the next highest dose cohort.