Anavex files Phase I regulatory submission for ANAVEX 2-73 in Alzheimer’s disease
Meets major clinical development milestone for lead compound
December 21, 2010
Hoboken, NJ December 21, 2010 - 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.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (www.anavex.com) is a biopharmaceutical company engaged in the discovery and development of novel drug candidates for the treatment of neurological diseases and cancer. The Anavex proprietary SIGMACEPTOR™ Discovery Platform involves the rational design of drug compounds targeted to specific receptors involved in the modulation of multiple cellular biochemical signaling pathways.
The SIGMACEPTOR™-N program involves the development of novel drug candidates that target neurological and neurodegenerative diseases (Alzheimer's disease, epilepsy, depression, pain). The company's lead drug candidates exhibit high affinity for sigma receptors, which have been extensively documented as potentially valuable drug targets and have demonstrated anti-amnesic and neuroprotective properties.
Anavex is a publically traded company under the symbol “AVXL”.
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Forward-looking statements in this press release include that we will complete a Phase I and IIa study in healthy human volunteers and patients, that Phase I will commence shortly and Phase IIa is currently scheduled to commence in mid 2011, and that our drug compounds show potential promise to combat certain diseases. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug discovery and development, which include, without limitation, the potential failure of development candidates to advance through preclinical studies or demonstrate safety and efficacy in clinical testing and the ability to pass clinical trials so as to move on to the next phase. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
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