Auritec receives Phase 2 funding for the manufacture of vaginal rings to prevent HIV transmission

Santa Monica, CA. July 15, 2011

Auritec Pharmaceuticals, Inc. is pleased to announce the receipt of a Phase 2 Small Business Advanced Technologies Innovation Research grant sponsored by the National Institutes of Health.  The grant will fund work to develop the capacity to manufacture vaginal rings to prevent HIV transmission.

Large efforts are currently underway funded by the NIH, the Gates foundation, and the WHO, to reduce the spread of HIV transmission by developing an effective microbicide. The a recent clinical trial with tenofovir gel by the CAPRISA study is the first demonstration of prophylaxis against HIV and HSV using a topical microbicide. Because protection increased with increasing adherence, and because intravaginal rings (IVRs) may increase adherence, the development of a ring formulation of tenofovir is an urgent global priority.

We have developed a platform technology for the sustained local release of antivirals that has led to the only FDA approved sustained-release antiviral device: the Vitrasert®. We propose to adapt this technology to develop a sustained release IVR formulation for tenofovir.

In phase 1 of this proposal, we completed safety and pharmacokinetic studies with rings releasing tenofovir.  In phase 2 we propose to the work necessary to obtain an IND from the FDA for the tenofovir IVR.  We will establish a GMP manufacturing facility for intravaginal rings; manufacture a lot sufficient to carry out pre-clinical studies under GMP; perform animal trials necessary to support an Industry Sponsored Investigational New Drug Application (IND); and manufacture lots of tenofovir drug-eluting intravaginal rings under Good Manufacturing Procedures sufficient for clinical trials.

The successful completion of this program will result in the granting of an IND from the FDA, and the production of clinical trial lots sufficient for pivotal trials.

            Auritec Pharmaceuticals is pleased to continue its relationships with Dr. Roger Jelliffe, MD, Dr. Betsy Harold, MD, and Dr. Marc Baum, PhD.

Roger Jelliffe MD, is Professor of Medicine and Director of the Applied Pharmacokinetics Laboratory in the University of Southern California. He is the primary author and developer of the USC*PACK Clinical Pharmacokinetics Computer Program  Dr. Jelliffe is on the editorial boards of journals in the field of therapeutic drug monitoring and is a recipient of the Award for Research Achievement in Clinical Medicine from the American Association of Pharmaceutical Scientists.

Marc Baum PhD, is President of Oak Crest Institute of Science and Visiting Associate at the California Institute of Technology, both in Pasadena CA. His Ph.D. was granted by the Imperial College of Science Technology and Medicine in London, England, in organic chemistry. The in vitro studies described below will be carried out at Oak Crest Institute under his supervision.

Betsy Herold MD, is Professor of Pediatrics and Microbiology in the Center for AIDS Research at Albert Einstein College of Medicine.  Her basic research focuses on defining the pathways required for genital herpes infection of human cells (R01 AI065309), and the interactions between HSV, HIV and genital tract mucosal immunity (R01 AI061679).  She has extensive experience studying virus-cell interactions.  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.  She will advise on clinical issues.

Auritec Pharmaceuticals is pleased to initiate a collaboration with John Van Bosch.  Mr. Van Bosh has had over 25 years’ experience in the development and manufacture of high technology medical products.  As President of Infinity Plastics, his previous company, he built and ran a GMP contract manufacturing facility for medical devices which included capabilities for product and process development, tooling, cleanroom silicone injection molding and secondary assembly, packaging and sterilization.

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.