Important note: Information in this article was accurate in 2000. The state of the art may have changed since the publication date.
PRNewsiwre - Tuesday November 14, 2000
The Phase I multi-center study took place in the United Kingdom among 105 women. Each participant inserted one dose daily of different formulations of SAVVY vaginal microbicide containing the active ingredient, C31G(TM), for a duration of three days. Primary endpoints included the percentage of women who experienced discomfort, such as itching or burning, and the percentage of women who would use the product again. The study concluded without any occurrences of Serious Adverse Events related to the microbicide. In addition, statistically significant, qualitative data pointed toward a tolerated, highly acceptable, and well-liked formulation of SAVVY vaginal microbicide.
"These results are very encouraging and allow us entry into longer term tolerance studies for SAVVY," stated Anne-Marie Corner, President & CEO of Biosyn. "Additionally, the confirmation that women would want to use our product if available satisfies a very important consideration for development of an effective vaginal microbicide." Further clinical development of SAVVY will proceed with this newly improved formulation.
In a Phase I study completed earlier this year at the University of Pennsylvania Medical School, it was found that SAVVY could be a safe and effective contraceptive. Upcoming clinical studies will investigate extended tolerance of SAVVY, contraceptive efficacy, and efficacy in the prevention of chlamydia, gonorrhea, and HIV / AIDS.
Biosyn is a research and development company focused on the development of novel, targeted delivery drugs for the treatment and prevention of infectious disease. Biosyn's core technology platform, along with its expertise in drug formulation and delivery, has allowed it to develop a portfolio of products that cross multiple areas of infectious disease, whether bacterial, fungal or viral. Other products in development include ORAMED(TM) and Gyne-Rx(TM). ORAMED is a therapy for oral infections associated with immuno-compromised conditions such as mucositis, herpes simplex-1, and candidiasis. Gyne-Rx is a presumptive therapy for non-STD vaginal infections including candidiasis (yeast) infections and bacterial vaginosis. Pre-clinical projects are ongoing for treatment of dermal and ophthalmic infections.
For more information, please contact Kathryn LaMaina at 215-387-5338 or khl@biosyn-inc.com.
SOURCE: Biosyn, Inc.
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