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Auritec to collaborate with Oak Crest Institute of Science to develop a tenofovir microbicide ring

Pasadena, CA. September 1, 2009

Auritec Pharmaceuticals, Inc. is pleased to announce a collaboration with Oak Crest Institute of Science (OCIS) in the development of an intravaginal ring that releases the microbicide tenofovir.  This work is funded by the US Recovery Act through the National Institutes of Health. 

The long term goal of this project is to empower women to protect themselves from HIV infection through the development of improved microbicides based on sustained release drug delivery. Each day 15,000 people are infected with HIV – a growing majority of them women. The development of an effective microbicide is thus of high programmatic relevance to the NIH, as well as other world health organizations.

The specific aims of the first year of the proposed efforts therefore are to formulate sustained release vaginal ring formulations for tenofovir, to test the in vitro release characteristics of these formulations into buffer and to determine the in vivo pharmacokinetics and the safety of the formulations in an animal model.

The specific aims of year 2 are to optimize the production parameters of the formulations and to validate the safety and tolerability of the formulation in two animal species.

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 fields 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.