Auritec receives Phase 2 funding for the development of Apomorphine for Parkinson’s disease
Pasadena, CA. September 27, 2007
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 to achieve a more continuous dopaminergic stimulation in the treatment of Parkinson’s disease (PD) through sustained release injections of apomorphine.
The long term goal of this work is to develop sustained release subcutaneous drug delivery systems in order to achieve a more continuous dopaminergic stimulation in the treatment of Parkinson’s disease (PD). The immediate goal of this project is to develop an injectable sustained release formulation for the recently approved agent apomorphine.
Apomorphine is useful in some patients, but often requires frequent injections because of its very short half life (ca 20 minutes). Often patients require 10 or more injections per day. In Europe, where there is a longer approval history with the drug, it is common to deliver apomorphine by continuous subcutaneous infusion. However, this treatment modality is cumbersome, prone to side effects, including the development of panniculitis at infusion sites, and furthermore is not approved for use in the United States.We have developed a proprietary subcutaneous sustained release platform technology based on suspensions of polymer-coated pure drug particles. High drug loading and sustained release kinetics have been achieved with several other drugs. Sustained release olanzapine and nevirapine have been demonstrated over 28 days in animals using this technology. In Phase 1 of this proposal we adapted the platform for the delivery of the dopaminergic agonist apomorphine.
The specific aims of this project are to optimize the parameters of the formulation and to complete the necessary preclinical work to apply for an FDA Investigational New Drug Exemption.
Auritec is pleased to continue its collaboration with Ross J. Baldessarini, MD, DSc (Hons.), DLFAPA, FACNP. Dr Baldessarini is an internationally-known neuroscientist and research psychopharmacologist who has made many contributions related to the basic scientific understanding of central monoaminergic systems, their involvement in the pathophysiology of neuropsychiatric disorders, and the interactions of antipsychotic and mood-altering agents with them. His recent interests have been directed particularly toward central dopaminergic systems of the brain and their relevance to the actions, adverse effects, development, and clinical application of antipsychotic and antimanic agents. He is widely regarded as having an unusually broad and critical perspective on the integration of basic research in neuroscience and pharmacology with problems in clinical research and contemporary psychiatric practice.
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 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.