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 I 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 by Syntagon AB ("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 in Sodertalje, 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.
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