Anavex Life Sciences has announced the completion of scale-up manufacturing of ANAVEX 2-73, its compound for the treatment of Alzheimer’s disease.
Herve de Kergrohen, CEO of Anavex, said: “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.
“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. Trials will confirm the drug’s safety and determine its tolerability in humans.
Pharmacokinetics and pharmacodynamics will also be studied during phase I. Anavex 2-73 has earlier demonstrated powerful neuroprotective, anti-amnesic, anti-convulsive and anti-depressive activity in animal models. It also exhibited safety profile and therapeutic activity at very low doses.
The two kilograms of Anavex 2-73 was manufactured by Syntagon.
“We are delighted with the quality, speed and responsiveness of Syntagon in manufacturing Anavex 2-73 for our clinical trials,” added Dr de Kergrohen.