Meets major clinical development milestone for lead compound
Anavex Life Sciences Corp. ("Anavex", AVXL:OB) announced today that it has filed the regulatory submission for ANAVEX 2-73 with the German Health Authority, BfArM, and the local Ethics Committee of Saxony to begin clinical studies for ANAVEX 2-73, its lead compound for the treatment of Alzheimer's disease.
"This regulatory filing marks an important milestone in the clinical development path for ANAVEX 2-73 and our strategy to aggressively complete a Phase I and IIa study in healthy human volunteers and patients, respectively," said Dr. Cameron Durrant, Executive Chairman of Anavex Life Sciences Corp.
Phase I dosing of healthy human volunteers with ANAVEX 2-73 is scheduled to begin shortly. A Phase IIa study in patients with Alzheimer's and Mild Cognitive Impairment may provide efficacy data as well as further safety data and is currently scheduled to commence in mid 2011.
"Our extensive pre-clinical program for ANAVEX 2-73 and the data generated so far offers the possibility of excellent safety and tolerability and encouraging signs of potential efficacy," added Dr. Durrant.
"The Phase I study will be comprised of a total of 24 healthy human volunteers to allow us to test the maximally tolerated dose, pharmacokinetics, pharmacodynamics, safety and bioavailability of ANAVEX 2-73," said Dr. Angelos Stergiou, Clinical Research Physician leading the program on behalf of Anavex and President of Genesis BioPharma Group.
The Phase I study will be carried out in collaboration with ABX-CRO and the University of Dresden in Germany.
ANAVEX 2-73 is the first of a new class of compounds which act through sigma-1 receptor agonism as well as muscarinic cholinergic effects and modulation of endoplasmic reticulum stress thought to trigger a series of intracellular effects which modify ion channel signaling at the mitochondrial level.
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