HUNTINGDON VALLEY, Pa. -- Biosyn, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted fast-track designation for the development program of 1.0 percent C31G vaginal gel for the reduction of HIV transmission. In granting the fast-track designation, the FDA recognized that HIV infection is a serious and life-threatening condition, there is an unmet need for a female controlled method to reduce the sexual transmission of HIV and 1.0 percent C31G has the potential to address this unmet medical need.
"We have worked closely with the FDA on the clinical path for this candidate since it is an important product for the prevention of sexual transmission of HIV," said Anne-Marie Corner, President & CEO of Biosyn. "The fast track designation will help accelerate our development of C31G vaginal gel."
Fast-track programs are designed to facilitate the development and expedite the review of new drug candidates that are intended to prevent or treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.
Biosyn's lead product candidate, 1.0 percent C31G vaginal gel is entering Phase III clinical trials. Planned studies include prevention of transmission of HIV, prevention of transmission of chlamydia and contraception. Other products in clinical development at Biosyn include UC-781, a non-nucleoside reverse transcriptase inhibitor in Phase I trials for the prevention of HIV transmission, 0.5 percent C31G oral rinse, a Phase II product candidate for management of oral infections associated with immune-suppression and cyanovirin-N (CV-N), a novel fusion inhibitor in preclinical development for the prevention of transmission of HIV.
1.0 percent C31G vaginal gel is in development for contraception and prevention of sexually transmitted diseases (STDs) including HIV, chlamydia and herpes. The United States has the highest rates of STDs in the industrialized world, and of the 40 million women in the United States who are currently using contraception, more than three-quarters are using a method that places them at risk of contracting an STD.
Biosyn is a specialty pharmaceutical company focused on the development and commercialization of novel drugs in the areas of infectious disease and reproductive health.
Source: Biosyn, Inc.