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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” or the “Company”) (“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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