BUSINESS WIRE; Wednesday, July 1, 1998
In a poster presentation, Procept scientists and colleagues described in vitro experiments showing that the antiviral compound PRO 2000 blocks infection by vaginal herpes simplex virus (HSV) types 1 and 2 and Chlamydia trachomatis. They also reported on the first in vivo evidence of PRO 2000 Gel's efficacy against an STD -- namely, findings that the gel provides complete protection against HSV-2 infection in mice. HSV-2 infection is a significant public health problem, and genital herpes lesions may provide a portal of entry for human immunodeficiency virus (HIV), the cause of AIDS. The Centers for Disease Control reported that 12 million new U.S. cases of sexually transmitted diseases are reported to the center each year.
The biannual World AIDS Conference is the premier international forum for all aspects of AIDS research. According to estimates issued by UNAIDS and the World Health Organization, approximately 5.8 million people contracted HIV worldwide in 1997 alone. In earlier laboratory studies, PRO 2000 was shown to prevent infection of cells by HIV (types 1 and 2).
PRO 2000 Gel is under development as a female-controlled product for protection against HIV infection and other sexually transmitted diseases, a key area of unmet need. "The development of safe and effective microbicides to prevent the sexual transmission of HIV and other STDs would make a substantial impact both in terms of protecting the individual and in terms of broader public health benefits," said Dr. Alan Stone, who has been closely associated with the British Medical Research Council-supported microbicide studies in the UK since their inception. "Careful research has identified several agents which appear to possess the combination of features required of a successful product and further work is now urgently needed to find out how best to realize their potential."
"We are very encouraged by the favorable data that have resulted so far," stated John F. Dee, Procept President and Chief Executive Officer. "The potential of this compound as an advancement in the area of womenis health and HIV prevention is significant. We are glad to have had an opportunity to share these key findings at the prestigious forum of the World AIDS Conference."
Detail On Animal Model Research and Phase I Clinical Trials
Key findings from Procept's in vivo HSV-2 research include the following:
--When 15 mice were treated vaginally with 4.0% PRO 2000 Gel, not one acquired HSV-2 infection after subsequent vaginal exposure to the virus. At the same time, 13 out of 15 mice that received a placebo died from the same viral exposure. These results were confirmed by follow-on experiments.
--PRO 2000 Gel provided significant protection even when applied up to 60 minutes before exposure to the virus. Other agents used in the experiments did not provide such sustained protection.
The experiments were performed under contract to the National Institute of Allergy and Infectious Diseases (NIAID) of the U.S. National Institutes of Health. Procept plans to continue conducting animal-model experiments to test PRO 2000 Gel's effectiveness against other sexually transmitted diseases.
In 1997, PRO 2000 Gel was shown to be safe and well tolerated in two successful Phase I human clinical trials conducted in Europe. During 1998, the Company plans to file an Investigational New Drug (IND) application with the FDA and initiate further clinical trials for PRO 2000 Gel in the United States, London, and South Africa.
Procept, Inc., located in Cambridge, MA, is a biopharmaceutical company currently engaged in the development of novel drugs for the prevention of infectious diseases. Its lead product, PRO 2000 Gel, is being developed as a female-controlled topical microbicide for the prevention of HIV infection and sexually transmitted diseases caused by herpes simplex virus type 2 and Chlamydia trachomatis. Procept also plans to outlicense its early-stage immunosuppressive research and to inlicense high potential drug development compounds.
Certain statements in this press release constitute "forward-looking statements" that involve risks and uncertainties, including those arising under the Company's business strategy; the success of the Company in financing efforts; the pursuit of collaborative arrangements for the research and development of product candidates, as well as the pursuit of joint development or licensing arrangements with pharmaceutical, diagnostic or instrumentation companies; the research or development of particular products, compounds or technologies; the uncertainty of the results of such development activities and related clinical trials or of required regulatory approvals; and the reliance on collaborative partners for development, regulatory or marketing activities.
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CONTACT: Procept, Inc. John F. Dee 617-491-1100 jdee@procept.com
Robinson Lerer & Montgomery Mary Ann Dunnell 212-484-7797 mdunnell@rlmnet.com
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