Auritec receives Phase 2 funding for maternal-infant transmission of HIV
-Pasadena, CA, September 22, 2006
Auritec Pharmaceuticals, Inc. is pleased to announce the receipt of a Phase 2 Small Business Innovation Research grant sponsored by the National Institutes of Health. The grant will fund work on preventing mother-to-infant transmission of HIV during breast-feeding
In the developing world, perinatal transmission is greatly reduced through relatively simple expedients, such as perinatal dosing of mother and child with nevirapine. However, breast-feeding still accounts for approximately 315,000 cases annually of pediatric AIDS in sub-Saharan Africa. Indeed, the more effective the prevention of perinatal transmission, the more HIV-positive mother - HIV-negative infant pairs there will be at risk for transmission through breast-feeding.
A Phase III trial (HPTN 046), sponsored by the NICHD and other institutes of the NIH, is underway to study daily oral nevirapine given to infants in order to reduce mother-to-child transmission (MTCT). It is well recognized that a program of daily oral dosing by mothers for 6 months will be very difficult to support in resource-poor countries, but the absence of better alternatives, such as clean water, necessitates the attempt.
The specific aims of this Phase 2 proposal are to optimize the production parameters of the formulation, manufacture lots for clinical trials under FDA Good Manufacturing Procedures (GMP), perform the required animal pharmacokinetic and safety studies in 2 species using Good Laboratory Procedures (GLP), and submit a request for an Investigational New Drug Exemption (IND) to the FDA. The successful completion of this project will lead rapidly to the development of an injectable dosage form that could deliver continuous prophylactic antiviral blood levels.
Auritec is pleased 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 is also pleased to continue its collaboration with Dr. John Sullivan, MD, for the duration of this project. Dr Sullivan is a Professor of Pediatrics, Program in Molecular Medicine and Director of the Office of Research for the University of Massachusetts Medical School. Dr. Sullivan's research interests are focused on viral pathogenesis with a strong interest in HIV-1 and herpes virus pathogenesis. He has had a long-term interest in clinical trials and participated in the discovery and development of the first FDA approved non-nucleoside reverse transcriptase inhibitor, nevirapine. Dr. Sullivan pioneered the use of nevirapine for the prevention of maternal-infant transmission of HIV-1, a treatment now being implemented throughout the developing world.
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 platforms in a wide range of drug classes, and subsequently license the technology to key partners to continue development, trials and eventual commercialization.