Auritec receives funding for the prevention of graft rejection
Pasadena, CA. June, 28, 2007
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 on preventing organ rejection in transplant patients.
The long term goal of the proposed research is to reduce toxicity and graft rejection resulting from dosing problems with the calcineurin inhibitors by developing sustained release subcutaneous injectable formulations for the drugs tacrolimus and cyclosporine. Substantial inter-and intra-patient variability means that even frequent drug monitoring cannot eradicate rejection because of sub-therapeutic troughs or toxicity due to higher than necessary peak levels. In addition, non-adherence with the daily oral dosing regimen is a major cause of graft failure, especially in adolescent patients. Pharmacokinetic modeling suggests that periodic subcutaneous dosing can reduce or eliminate many of these problems. The potency and the long elimination half life of these drugs make them suitable for depot formulation. In previous work, supported in part through SBIR Phase 1 and 2 funding, the PI has developed sustained release formulations approved by the FDA for the treatment of CMV retinitis, and for uveitis. We also have developed an intraocular delivery formulation for cyclosporine that proved useful in clinical trials in posterior uveitis and a preliminary subcutaneous formulation of cyclosporine that demonstrated modest sustained release. We have now developed, in part with NIH SBIR funding, a platform delivery technology for subcutaneous injectable sustained release that has demonstrated promising results in vivo for a range of drugs, and that we believe can achieve clinically useful sustained release for the calcineurin inhibitors.
The specific aims of this proposal are to formulate sustained release suspensions of tacrolimus (TAC) and cyclosporine (CsA), test the in vitro release characteristics of these formulations, and test the in vivo pharmacokinetics and the local safety of the formulations in animals.
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 pleased to announce a collaboration with Thomas C. Pearson MD, D.Phil. Dr Pearson is Livingston Professor of Surgery, Director of the kidney transplant program and Co-director of the pancreas transplant program at Emory University. His research has beeb targeted primarily at co-stimulatory blockade to prevent organ rejection.With the aid of a five-year interdisciplinary $7.5 million grant from the National Institutes of Health, Dr. Pearson is working to establish true immune tolerance among transplant recipients.
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.