Auritec receives Phase 2 funding for the treatment of schizophrenia
Santa Monica, CA. June 1, 2010
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 the treatment of schizophrenia.
The long-term goal of this research is to minimize morbidity due to non-adherence to outpatient antipsychotic-antimanic therapy. Olanzapine is currently a mainstay of treatment for psychotic disorders and mania. Most psychotic and manic-depressive disorders require long-term, maintenance treatment, in which reliable and sustained adherence to therapy is a major clinical challenge and limitation to therapeutic effectiveness. Long-term adherence to antipsychotic treatment can be enhanced with long-acting, injectable preparations. Based on the clear clinical need and market opportunity, we have developed a formulation of olanzapine, currently one of the most widely clinically employed and versatile antipsychotic-antimanic agents. This preparation promises to support twice-monthly administration of olanzapine. We believe that the development of an injectable sustained release olanzapine is readily achievable and that it will become a useful tool in the outpatient treatment of patients with highly prevalent major mental disorders including schizophrenia and manic-depressive illness, which together affect several percent of the general population at any time
In Phase 1 of this work we formulated an injectable subcutaneous sustained release delivery system for olanzapine that maintains plasma levels in the rat for periods of greater than 21 days with no evidence of local toxicity. This represents a significant improvement over competing technologies. In this phase 2 project we optimize and manufacture our SR olanzapine for use in future clinical trials.
Completion of these aims and the granting of an IND will constitute a readily identifiable milestone that will allow us to continue in FDA Phase I and II clinical trials which will confirm the safety of the formulation in volunteers and compare the oral to the sustained release formulation of the drug. Such a preparation of olanzapine promises significant innovation for the in the treatment of schizophrenia, mania, and other highly prevalent, incurable, psychotic disorders.
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 field 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 Dr. Frank Tazari, PhD. Dr. Tazari is an Associate Professor of Psychiatry and Neuroscience at Harvard Medical School. He is on the editing board of 6 neuroscience journals, has received over 15 research awards, and has published 77 peer reviewed articles on various topics in neuroscience.
About Auritec Pharmaceuticals
Auritec Pharmaceuticals, Inc. based in Santa Monica and Pasadena, CA, is a R&D company specializing in innovative, extended release drug delivery systems. Auritec was founded by Thomas J. Smith, MD, who has been granted 8 INDs and 2 NDAs throughout his pharmaceutical career in sustained release drug delivery. 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’s Plexis™ technology is an innovative, polymer-based, proprietary platform technology for sustained release of drugs given by injection. Plexis™ combines a membrane based, diffusion-driven release mechanism with drug particle sizing large enough to allow high drug loading, but small enough to be injected. Plexis™ combines the benefits of linearization of release with those of injectability.
Auritec’s Versa™ technology is an implantable drug delivery platform that is responsible for two FDA approved products. It is based on a core of solid drug, coated with a semi-permeable polymer.
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. Auritec has been previously funded by numerous NIH grants and their IP estate includes worldwide granted and pending patents.