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Phase I testing of HIV microbicide initiated.
2003 OCT 2 - (NewsRx.com & NewsRx.net) -- Biosyn, Inc., announced that enrollment has been initiated for a phase I clinical trial for the investigational drug candidate, UC-781, as a microbicide for the prevention of sexually transmitted HIV.
UC-781 is an HIV non-nucleoside reverse transcriptase inhibitor (NNRTI) that has shown in vitro to be very active specifically against HIV-1.
This first clinical trial of UC-781 is a single-center, phase I, placebo-controlled, closed-label, randomized study to evaluate the safety and acceptability of daily intravaginal dosing of the product among 48 healthy sexually abstinent women. Participants will be administering 3.5 ml of 0.1%, 0.25%, 1.0% UC-781 gel, or placebo gel once daily for a total of 6 consecutive days with clinical evaluations to take place after the first and sixth applications.
The Contraceptive Research and Development Program (CONRAD) is conducting the study in behalf of Biosyn at Eastern Virginia Medical School in Norfolk, VA with funds from its Global Microbicide Program. "We are pleased to be so closely involved with Biosyn in the development of UC-781 as an HIV microbicide," stated Henry Gabelnick, PhD, director of CONRAD. "UC-781 has potential to address the significant need that exists for new means of preventing sexual transmission of HIV."
"UC-781 is Biosyn's third product candidate to enter clinical trials and the company's second product candidate ...
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