Auritec receives funding for the development of Herpes Intravaginal Ring
Pasadena, CA. February 25, 2009
Auritec Pharmaceuticals, Inc. is pleased to announce the receipt of a Phase 1 Small Business Innovation Research grant sponsored by the National Institutes of Health. The grant will fund work to prevent the transmission of genital herpes using an intravaginal ring.
The broad goal of this project is to reduce the transmission of HIV. Co-infection with genital herpes (HSV) significantly increases the rate of HIV transmission. Funded by the NIH, the Gates Foundation and the WHO, efforts are currently underway to reduce the spread of HIV by reducing the spread of HSV. We have developed a platform technology for the sustained local release of antivirals that has led to the only FDA approved sustained-release antiviral implant: the Vitrasert®. We propose to adapt this technology to develop a sustained release intravaginal ring formulation for acyclovir in order to reduce HSV and therefore HIV transmission. Demonstration of a reduction of genital HSV infection in a murine model would provide a proof of concept and support subsequent efforts to develop such a system.
The specific aims of Phase 1 of this proposal therefore are to formulate intravaginal implants releasing acyclovir for use in animal studies, confirm appropriate in vitro release rates, test the pharmacokinetics, preliminary safety, and efficacy in a murine model of HSV transmission.
Auritec is pleased to collaborate with two experts in the HIV/herpes field, Drs. Betsy Herold and Angela Kashuba. Betsy Herold, MD, has recently joined the faculty and the Center for AIDS Research at Albert Einstein College of Medicine as Professor of Pediatrics and Microbiology. Her basic research focuses on defining the pathways required for genital herpes infection of human cells,and the interactions between HSV, HIV and genital tract mucosal immunity. Her laboratory has performed pre-clinical studies of multiple topical microbicides, including several sulfonated polymers currently in clinical trials, acid buffering agents, and topically formulated antiretroviral drugs. She has expanded the murine model to study both the efficacy and safety of vaginally applied microbicides. She currently serves on the Scientific Development Committee of the Microbicide Trial Network as the Chair for microbicide safety biomarkers and on the Scientific Advisory Board of IPM. She is also a member of the Office of AIDS Research Advisory Council.
Angela Kashuba, BScPhm, PharmD, DABCP, is an Associate Professor of Pharmacy, Director of the UNC Center for AIDS Research Clinical Pharmacology and Analytical Chemistry Core, and Director of the UNC General Clinical Research Center’s Analytical Chemistry Laboratory. Dr. Kashuba is board certified by the American Board of Clinical Pharmacology, and her current research interests include prevention of HIV transmission using systemic and topical small molecules. Her Clinical Pharmacology Laboratory has been CLIA certified since 2004, and participates in quarterly external proficiency testing of antiretrovirals through national and international programs. The laboratory has robust multiplex methods to measure 17 antiretrovirals in numerous human and animal biological matrices, including blood plasma, genital secretions, and tissues.
Auritec is please to continue its collaboration with Dr. Roger Jelliffe, MD. Dr. Jelliffe is a Professor of Medicine and the Director of the Applied Pharmacokinetics Laboratory at the University of Southern California. He is the primary author and developer of the USC*PACK Clinical Pharmacokinetics Computer Program. He has published extensively on clinical pharmacokinetics. Dr. Jelliffe is on the editorial boards of journals in the field of therapeutic drug monitoring and computers in medicine. He was Chairman of the Pharmacometrics Section of the American Society for Clinical Pharmacology and Therapeutics and is a recipient of the Award for Research Achievement in Clinical Medicine from the American Association of Pharmaceutical Scientists.
Auritec Pharmaceuticals, Inc. is a small company based in Pasadena, California, specializing in innovative, extended release drug delivery systems. Auritec was founded by Thomas J Smith, MD and Gary Ransom. Dr Smith was previously Medical Director and Chairman at Control Delivery Systems, Inc. (CDS), where he was the co-founder, PI on key patents and remains a significant shareholder. Dr Smith is joined on Auritec's management team by Gary Ransom, a seasoned international business executive, who focuses on strategy, marketing and business development.
Auritec has developed a novel approach to extended release drug delivery with implications so far for indications including schizophrenia, Parkinson’s disease, arthritis, herpes and HIV/AIDS. Auritec’s primary objective is to develop and test the use of its Plexis and Versa platforms in a wide range of drug classes, and subsequently license the technology to key partners to continue development, trials and eventual commercialization.