Hybridon Inc. said Wednesday it received FDA approval to beginPhase IA trials of its antisense oligonucleotide, GEM 91, for thetreatment of HIV and AIDS.Initial trials at the University of Alabama at Birmingham, will study thepharmocokinetics and safety of a single dose of GEM 91 in HIV-infected volunteers. The Worcester, Mass., company is hoping to startpatient enrollment and dosing the week of April 18. Six patients will beenrolled.The drug was well-tolerated by 23 HIV patients in a Phase IA study ofGEM 91 in France, and no clinically significant side effects wereshown, the company said.GEM 91 is designed to bind selectively with a conserved site on thegag messenger RNA, which codes for a protein essential to HIVreplication. In various in vitro tests, GEM 91 demonstrated significantinhibition of replication of HIV, Hybridon said.
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