New Topical Prophylactic Agent for Genital Herpes

Period of Performance: 09/01/1998 - 02/28/1999

Unknown

Phase 1 SBIR

Recipient Firm

Redox Pharmaceutical Corporation
Greenvale, NY 11548
Principal Investigator

Abstract

Redox Pharmaceutical Corporations's new antiviral and anti- inflammatory metallo-organic compound, CTC 96 (DoxovirTM) has demonstrated activity against herpes simplex virus type 1 (HSV-1) in cell culture and animal models of ocular disease. The closely related HSV-2, which is the cause of 45 million cases of genital herpes infection in the US alone, will be studied in animal models and cultured cells. In preliminary experiments, prophylactic treatment with CTC 96 completely prevented replication of virus or development of disease in the mouse vaginal tract. This experiment will be repeated in guinea pigs, which manifest genital herpes more closely modeling the human disease. Both animal models will be used to determine the dose-dependence and time-dependence of optimal prophylactic efficacy. Experiments to determine whether the CTC 96 site of action is the virus, the host cell, or some product of viral infection will be carried out on purified virus and on cultured cells. Redox intends to formulate an anti-herpetic vaginal microbicide and pursue FDA approval for human clinical testing (IND) as part of a phase II SBIR application. PROPOSED COMMERCIAL APPLICATION: This research will clarify the potential use of Redox's antiherpetic agent (CTC 96; DoxovirTM) for prevention of genital herpes. There are about 700,000 primary cases and 20 million recurrences annually in the US alone. Yearly worldwide sales of the leading antiherpetic drug, acyclovir, exceed 1 billion dollars. DoxovirTM could also be used for orofacial herpes (about 50,000,000 cases per year) and other dermal herpes infections (e.g., shingles). Potential markets include infectious disease specialists, dermatologists and general practitioners world-wide and their patients.