Anavex Confirms Data from Phase 2a Study of ANAVEX 2-73 in Alzheimer’s Patients Presented at AAIC 2016
NEW YORK – July 29, 2016
Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), confirms the information in the July 27, 2016 press release announcing positive results from the Phase 2a Alzheimer’s trial for ANAVEX 2-73.
Dr. Norman Relkin, MD, PhD, an Alzheimer clinical trialist and an advisor to Anavex, commented: “To interpret the ANAVEX 2-73 results presented at the 2016 AAIC meeting, it is important to keep in mind the stated goals of this first in Alzheimer’s patients study. This was a Phase 2a study, primarily designed to determine which ANAVEX 2-73 dosages are safe to administer to mild to moderate stage Alzheimer’s patients. The study was successful in establishing the maximum tolerated dose and in revealing the range of ANAVEX 2-73 doses that are well-tolerated by Alzheimer patients. It also provided encouraging evidence that previously reported positive trends in certain cognitive and biologic measures persisted over a period of approximately 31 weeks. However, this analysis was based on pooled data from a relatively small number of subjects receiving a variety of doses. It is therefore unlikely that these findings reflect the full potential ANAVEX 2-73 in treating Alzheimer’s disease. It is unreasonable to draw conclusions about any limits to the long-term efficacy of ANAVEX 2-73 based on the interim Phase 2a findings, especially since no statistically significant decline from baseline was reported, which is impressive. Detailed pre-planned analysis of the pharmacodynamic results is in progress, which is one of the key factors of relevance for regulatory agencies and which will also determine the optimal dose for future studies.”
Anavex confirms that there has been no change with regards to its science, data or the fundamentals of the Company. Anavex remains dedicated to advancing ANAVEX 2-73 and will be reporting new data to investors as it becomes available.
Anavex confirms the data included in its news release dated July 27, 2016.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental diseases including Alzheimer’s disease, other central nervous system (CNS) diseases, pain and various types of cancer. Anavex’s lead drug candidate, ANAVEX 2-73, is currently in a Phase 2a clinical trial for Alzheimer’s disease. ANAVEX 2-73 is an orally available drug candidate that targets sigma-1 and muscarinic receptors and successfully completed Phase 1 with a clean safety profile. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease. It has also exhibited anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy and others. The Michael J. Fox Foundation (MJFF) for Parkinson’s Research has awarded Anavex a research grant to develop ANAVEX 2-73 for the treatment of Parkinson’s disease to fully fund a preclinical study, which could justify moving ANAVEX 2-73 into a Parkinson’s disease clinical trial. ANAVEX 3-71, also targeting sigma-1 and M1 muscarinic receptors, is a promising preclinical drug candidate demonstrating disease modifications against the major Alzheimer’s hallmarks in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid and tau pathologies, and also with beneficial effects on neuroinflammation and mitochondrial dysfunctions. Further information is available at www.anavex.com.
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. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. 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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