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Clinical Trial Underway for HIV Prevention Gel

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May 21, 2004 1:40 PM PDT    Text size: 
HUNTINGDON VALLEY, Pa. – A possible HIV prevention solution is in the final stages of testing as the drug maker, Biosyn Inc., enters a clinical trial phase funded by the United States Agency for International Development.

Biosyn's 1% C31G Vaginal Gel is expected to help reduce the sexual transmission of HIV in addition to sexually transmitted infections like chlamydia and herpes. The drug is currently on an FDA-approved "fast-track" designation status for getting tested and to market as soon as possible, Biosyn announced on Friday.

The product is a microbicides, an intravaginal product that drug makers think could have a resounding impact on the spread of HIV.

According to Biosyn's statistics, the United States has the highest rates of sexually transmitted infections than any other country in the industrialized world.

Biosyn's clinical testing phase will include 2,200 women in high-risk areas of Africa and Ghana. The study's participants will be given the drug at specified sites throughout those countries in addition to being counseled on safe-sex practices. Some of the study's participants will be given a placebo gel instead.

Biosyn will also conduct the same testing process in Nigeria at a yet-undetermined time.

"We are very excited to be the first company to initiate clinical trials with a vaginal gel for the prevention of the sexual transmission of the virus that causes AIDS," said Anne-Marie Corner, president and CEO of Biosyn. "We are deeply committed to the global effort to reduce the spread of AIDS both here in the United States and worldwide and hope to expeditiously advance 1 percent C31G toward commercialization, provided the data meet our expectations."

June 27 is officially National HIV Testing Day with a theme this year of "It's Better to Know." The National Association of People with AIDS uses the chosen day to encourage at-risk people to get tested and for those individuals who have never been tested to seek voluntary counseling and testing.

The Centers for Disease Control and Prevention estimates that as many as 280,000 people in the United States are HIV-positive and unaware of their status.

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