In continuation of my update on antisense drugs and RNAi
AVI BioPharma Inc. announced positive safety results from the first
five cohorts of Phase 1 single ascending dose trials of AVI-6002 and
AVI-6003, AVI's lead drug candidates being evaluated for the treatment
of the Ebola virus and Marburg virus.
Data were evaluated by an independent Data and Safety Monitoring
Board (DSMB), which issued recommendations for both studies to progress
as planned to the next highest dosing level after no safety concerns
were identified. The Phase 1 single ascending dose trials are designed
to characterize the safety, tolerability, and pharmacokinetics of each
therapeutic candidate in healthy adult volunteers.
"We are very encouraged that these two drugs, which use our advanced PMOplus chemistry, have demonstrated a favorable safety profile through five cohorts in our dose-escalation studies,”says Chris Garabedian, president and chief executive officer of AVI BioPharma...
Ref : http://phx.corporate-ir.net/phoenix.zhtml?c=64231&p=RssLanding&cat=news&id=1619940
To date, 25 healthy human subjects (five per group) have been
enrolled into five sequential dose groups in each of the two studies.
Within each group, four subjects received the indicated dose of the
therapeutic and one subject received placebo. For each group, safety,
clinical laboratory and renal biomarker results through five days after
treatment were reviewed by a DSMB. Subjects enrolled in the sixth group
for the drug studies will receive 9.0 mg/kg of the therapeutic or
placebo. Final, un-blinded safety and pharmacokinetic results for all
subjects will be available upon completion of the trial.
Both candidates employ 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.
