translation agency

PR Newswire
Biosyn Announces Positive Clinical Results of Two Phase I/II Trials For Savvy(R) Microbicide Gel

May 13, 2002
HUNTINGDON VALLEY, Pa., May 13 /PRNewswire/ -- Biosyn, Inc. announced today at the Microbicides 2002 Conference in Antwerp, Belgium, successful results of two clinical studies for Savvy(R) (C31G intra-vaginal gel), currently in development as a contraceptive and for the prevention of sexually transmitted diseases (STDs). Presented were results of a Phase I/II Dose Escalation study in which sixty-four women used Savvy(R) gel in single and multiple doses for two weeks. Data from the trial indicated that Savvy(R) met the primary endpoints of safety and acceptability. Results of the second trial, a Phase I/II Post-Coital Testing (PCT) study investigating the safety and spermicidal efficacy of three different concentrations of Savvy(R), were also presented at the conference. This study also met the primary endpoints of safety and spermicidal efficacy when Savvy(R) was administered prior to intercourse.

"The Phase I/II Dose Escalation and PCT studies are great successes for the company," commented Richard P. Bax, M.D., Chief Scientific Officer of Biosyn. "Both trials directly point toward a dose that we feel confident in moving forward into pivotal Phase II/III clinical trials later this year."

Savvy(R) is being developed by Biosyn as a female-controlled contraceptive with additional indications for the prevention of STDs. The two recently completed studies were conducted in collaboration with the Contraceptive Research and Development Program (CONRAD), based in Arlington, Virginia.

Savvy(R) is expected to enter Phase II/III clinical trials later this year to investigate the product's efficacy as a contraceptive and in preventing transmission of STDs including chlamydia, genital herpes and gonorrhea.

Shortly thereafter, clinical trials investigating the product's efficacy in preventing HIV transmission are likely to be initiated in Africa and Asia.

Savvy(R) is Biosyn's lead candidate within a strong portfolio of microbicides undergoing clinical and preclinical development at the company.

The portfolio is based upon core technologies having different modes of action against a number of STD pathogens including HIV, chlamydia, herpes simplex virus (HSV), human papilloma virus (HPV), and gonorrhea. The company has also developed several formulations for safe and effective delivery of these microbicides.

"There exists an urgent need in the U.S. for a product that women can use to protect themselves and their partners from sexually transmitted diseases and we are extremely encouraged by the results of these studies and the promise this microbicide shows," said Anne-Marie Corner, President & Chief Executive Officer of Biosyn. "Our expectations are equally as high for Biosyn's other microbicides in development, which are designed to provide additional options for women in protecting their reproductive health."

About Biosyn

Biosyn is a specialty pharmaceutical company developing novel, topical- delivery drugs for the treatment and prevention of infectious disease in areas of critical medical need. The company has built a robust pipeline based upon proprietary technology platforms addressing major anti-infective markets where the use of topical delivery offers significant advantages over systemic therapy. In addition to its microbicide portfolio, the company has product development ongoing in several areas including oral complications of immuno- suppression, skin and soft tissue infections, and ophthalmic infections.