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
"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
"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."
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.