Auritec receives Phase 2 funding for the prevention of graft rejection
Santa Monica, CA. March 13, 2009
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 organ rejection in transplant patients.
The long term goal of this research is to reduce toxicity and graft rejection due to dosing problems with the calcineurin inhibitors by developing a sustained release subcutaneous injectable formulation of a calcineurin inhibitor. Substantial inter-and intra-patient variability of the calcineurin inhibitors cyclosporine A (CsA) and tacrolimus (Tac), means that even frequent drug monitoring cannot eradicate rejection due to 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-lives of CsA or Tac make them suitable for depot formulation.
In Phase 1 we developed sustained release formulations for cyclosporine and tacrolimus, measured their in vitro dissolution and demonstrated tolerability and sustained release in an in vivo model. We have decided to focus on the development of sustained release CsA in this Phase 2 proposal because it was easier to crystallize and demonstrated superior pharmacokinetics when tested in rats. In addition, because the patents for the parent drug have expired for CsA (and remain in effect for Tac until 2013), we believe that there will be more flexibility in partnering for further development of CsA.
The specific aims of this Phase 2 proposal are to optimize the parameters of the sustained release CsA formulation, manufacture clinical lots of the optimized formulation under GMP, perform animal toxicity and pharmacokinetic studies in rats.
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 is pleased to continue its 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 been primarily targeted 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.