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Sustained release acyclovir for prophylaxis of genital herpes

Award Information

Department of Health and Human Services
Award ID:
Program Year/Program:
2009 / SBIR
Agency Tracking Number:
Solicitation Year:
Solicitation Topic Code:
Solicitation Number:
Small Business Information
1512 11th Street SANTA MONICA, CA -
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Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
Phase 1
Fiscal Year: 2009
Title: Sustained release acyclovir for prophylaxis of genital herpes
Agency: HHS
Contract: 1R43AI081552-01
Award Amount: $223,952.00


DESCRIPTION (provided by applicant): The broad long term goal of this project is to empower women to protect themselves from HSV and HIV infection through the development of an HSV microbicide based on sustained release drug delivery. Each day 15,000 peopl e are infected with HIV- a growing majority of them women. Fifty million Americans are infected with genital herpes, and the disease is common in areas of the world of high HIV prevalence. Because genital herpes dramatically increases the transmissibility of HIV programs, the development of an effective method to reduce the spread of HSV is of high programmatic relevance to the NIH as well as other world health organizations. We have developed a platform technology for the sustained release of a broad range of drugs by implantation which maintains antiviral levels for long periods. This technology lead to the ganciclovir intraocular implant: the Vitrasert(R), approved for the treatment of AIDS related CMV retinitis. We propose to utilize this platform to dev elop sustained release vaginal ring formulations for acyclovir. We have formulated prototype rings that release acyclovir in a linear fashion over 30 days. In this Phase 1 project we propose to formulate and test sustained release acyclovir implants in vit ro and then test their safety and efficacy in an established animal model. PUBLIC HEALTH RELEVANCE: Infection with genital herpes dramatically increases the risk of the spread of HIV. The broad long term goal of this project is to protect women currently u ninfected by genital herpes from infection by developing an effective intravaginal ring microbicide based on the sustained release drug delivery of acyclovir. We will formulate prototype intravaginal devices for use in animals, confirm the safety and deliv ery of acyclovir over prolonged periods, and test the hypothesis that topical acyclovir can prevent infection in an animal model. The successful incorporation of acyclovir into a ring based microbicide could have a dramatic impact on the evolution of the A IDS pandemic.

Principal Investigator:

Thomas J. Smith

Business Contact:

Thomas J. Smith
Small Business Information at Submission:

AURITEC PHARMACEUTICALS, INC. 1434 6th Street, #3 Santa Monica, CA 90401

EIN/Tax ID: 841629188
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No