Anavex Completes Scale-Up Manufacturing of ANAVEX 2-73 for Phase I Alzheimer’s Disease Clinical Trials
Geneva, Switzerland — September 21, 2009 — Anavex Life Sciences Corp., (“ANAVEX”) (OTCBB: AVXL) today announced the completion of scale-up manufacturing of ANAVEX 2-73, its lead compound for the treatment of Alzheimer’s disease.“With sufficient quantities of ANAVEX 2-73 in hand we are an important step closer to the commencement of Phase 1 clinical trials, which are scheduled to begin in early 2010,” said Dr. Herve de Kergrohen, CEO of ANAVEX. “This lead drug candidate shows potential to alter the course of Alzheimer’s disease by using sigma receptors to correct dysfunction in the mitochondria and ultimately protect cells from oxidative stress, which is believed to be an underlying cause of the disease.”
ANAVEX will shortly announce the selection of the Contract Research Organization (CRO) in charge of carrying out its Phase I clinical trials. Phase I is the stage at which testing moves to humans. Trials are designed to confirm the drug’s safety and determine its tolerability in humans. Pharmacokinetics (the mechanisms of absorption and distribution of the drug, the rate at which a drug begins to act and the duration of its effect, as well as chemical changes of the substance in the body) and pharmacodynamics (physiological effects of drugs on the body, mechanisms of action and relationship between drug concentration and effect) are also studied during Phase I. ANAVEX 2-73 has already demonstrated powerful neuroprotective, anti-amnesic, anti-convulsive and anti-depressive activity in animal models. It also exhibited an excellent safety profile and therapeutic activity at very low doses.
The two kilograms of ANAVEX 2-73 was manufactured bySyntagonAB(“Syntagon”) under GMP conditions, the quality assurance system required in the production of medicinal products. Syntagon developed a five-step synthetic procedure that achieved excellent yields in terms of the quantity of the compound that was produced and delivered it to ANAVEX on time. In addition, all analytical methods were evaluated and developed at Syntagon.
Syntagon is a provider of synthetic organic chemistry services headquartered inSodertalje, Sweden. The company has produced candidate drugs for use in clinical trials for a number of major pharmaceutical clients. Syntagon works in accordance with current industry quality standards, and is inspected and approved by the relevant regulatory authorities with respect to the development and manufacturing of material for use in clinical trials.
“We are delighted with the quality, speed and responsiveness of Syntagon in manufacturing ANAVEX 2-73 for our clinical trials,” added Dr. de Kergrohen.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (www.anavex.com) is a global company with headquarters inSwitzerland. The company is engaged in the discovery and development of novel drug targets for the treatment of neurological diseases and cancer. ANAVEX’s proprietary SIGMACEPTOR™ Discovery Platform involves the rational design of drug compounds that fulfill specific criteria based on unmet medical and market needs and new scientific advances.
ANAVEX’s SIGMACEPTOR™-N program involves the development of novel drugs that target neurological and neurodegenerative diseases, such as Alzheimer’s disease, epilepsy, depression, pain and neuropathic pain. The company’s lead candidates have shown strong evidence for anti-amnesic and neuroprotective properties in studies conducted to date. ANAVEX believes that mitochondrial dysfunction can be modulated via sigma receptors, a unique class of receptor molecules, to guard against oxidative stress.
ANAVEX’s SIGMACEPTOR™-C program involves the development of novel drugs targeting cancer. The company’s lead candidates have shown strong evidence for selective pro-apoptotic, anti-metastatic and low toxicity properties in various types of solid cancers. ANAVEX 7-1037 has already demonstrated its ability to significantly delay the growth of cancerous tumors in patient-derived xenografts during advanced pre-clinical studies.
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug discovery and development, which include, without limitation, the potential failure of development candidates to advance through preclinical studies or demonstrate safety and efficacy in clinical testing and the ability to file an IND or commence clinical studies. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
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