application): The applicant~s new organometallic antiviral, CTC 96 (Doxovir (TM)) 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 U.S. alone, is sensitive to CTC-96 used as a vaginal microbicide in animal models. CTC-96 also inactivates human immunodeficiency (AIDS) virus. No FDA-approved microbicide or vaccine is available for either disease. Formulating a CTC-96 microbicide and testing it for use by women is the goal of this Phase II SBIR application. CTC-96 activity against a range of sexually transmitted pathogens will be surveyed, as will its effects on sperm and vaginal health. Formulations will be designed and optimized for efficacy, safety, and convenience. Uptake, disposition, and excretion of CTC-96 will be determined using radio labeled material in animals. The agent~s mechanism of action will be investigated to facilitate rational development of other related metallo-organic therapeutics. FDA guidance and approval will be sought for initial clinical testing, which will be conducted as part of this SBIR program.
The research will clarify the potential use of Redox~s antiherpetic agent (CTC-96; Doxovir (TM)) for prevention of genital herpes and other STDs. 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. Doxovir (TM) 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. Efficacy in preventing AIDS would significantly extend market demand.