Anavex Life Sciences Corp. announced that its clinical trial application (CTA) for ANAVEX 2-73, the company's lead compound for Alzheimer's disease, has been approved by the German regulatory health authority, BfArM. The Phase 1 trial of ANAVEX 2-73, which includes testing in healthy human volunteers, will commence immediately. In this Phase 1 program Anavex will assess the safety, maximally tolerated dose, pharmacokinetics and pharmacodynamics of ANAVEX 2-73.
"We are excited to have received the German regulatory health authority's approval to take ANAVEX 2-73 into the clinic. This marks a key milestone for our company," said Dr. Cameron Durrant, Executive Chairman of Anavex.
"We are very pleased to have received this approval, which supports the data generated thus far on ANAVEX 2-73. The CTA package submitted was of the quality required to pass this stringent regulatory review by the Germany Health Authority, BfArM," said Dr. Angelos Stergiou, Anavex's Vice President, Clinical Development & Medical Affairs.
ANAVEX 2-73 is the first of a new class of wholly owned compounds that act through sigma-1 receptor agonism as well as muscarinic and cholinergic effects and modulation of endoplasmic reticulum stress to trigger a series of intracellular effects thought to modify ion channel signalling at the mitochondrial level.
"I wholeheartedly support ANAVEX 2-73 progressing into Phase 1. 1 have been following the progress of this drug and 1 hope this important trial will be just the beginning of an exciting journey we have ahead of us," said Dr. Jeffrey Cummings, member of the Anavex Scientific Advisory Board, Professor of Neurotherapeutics and Drug Development in the Neurological Institute, Cleveland Clinic and Director of the Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas, Nevada and Cleveland, Ohio.
The Phase 1 clinical trial of ANAVEX 2-73 will be carried out in collaboration with ABX-CRO and the University of Dresden in Germany.
