Anavex Encouraged by Data Showing Sigma-1 Receptor Reduces Tau Dysfunction, a Hallmark of Alzheimer’s Disease
New Report Validates Therapeutic Application of Anavex Compounds in Tau Diseases
NEW YORK – May 21, 2015
Anavex Life Sciences Corp. (“Anavex” or the “Company”) (OTCQX: AVXL), a clinical-stage biopharmaceutical company developing drug candidates to treat Alzheimer’s disease, other central nervous system (CNS) diseases, pain, and various types of cancer, is encouraged by recent data published in the Proceedings of the National Academy of Sciences. The research determines that activating the sigma-1 receptor with agonists can potentially reduce the devastating impact of tau dysfunction. Abnormal tau phosphorylation is a common characteristic in multiple neurodegenerative diseases. Alzheimer’s is the most widely recognized neurodegenerative disease associated with the aggregation of tau protein in the brain, with others including progressive supranuclear palsy (PSP) and frontotemporal dementia.
It has been previously reported that ANAVEX 2-73, targeting the sigma-1 receptor in a dose-dependent study, blocked tau and amyloid-beta (“amyloid”) proteins as well as memory deficits in a mouse model of Alzheimer’s disease. This data was published in the international scientific journal Neuropsychopharmacology. A reduction in these two main hallmarks of Alzheimer’s has the potential to stop, slow or reverse the disease. ANAVEX 2-73 is currently in a Phase 2a study for Alzheimer’s disease, and the Company expects to report preliminary data around the Q3 2015 timeframe.
“We are pleased to see further potential for our sigma-1 drug therapeutics, including ANAVEX 2-73, to prevent tau toxicity in Alzheimer’s and also possibly in other CNS diseases,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “Our team is excited by the findings of this publication and looks forward to the reporting of preliminary data for the Phase 2a Alzheimer’s trial later this year.”
The scientific paper, entitled “Sigma-1 receptor regulates Tau phosphorylation and axon extension by shaping p35 turnover via myristic acid,” is authored by S.Y. Tsai, T.-P. Su, et al., from the, National Institute on Drug Abuse, National Institutes of Health (NIH), US Department of Health and Human Services in Baltimore, MD.
About ANAVEX 2-73
ANAVEX 2-73 is an orally available small molecule that targets sigma-1 and muscarinic receptors, which have shown in preclinical studies to reduce stress levels in the brain. ANAVEX 2-73 is currently undergoing a Phase 2a clinical trial for Alzheimer’s disease. A Phase 1 trial of ANAVEX 2-73 was successfully completed and showed no safety issues or toxicity signals. A total of 22 healthy male volunteers received single ascending oral doses of ANAVEX 2-73 to determine the maximum tolerated dose and investigate what, if any, side effects may result. ANAVEX 2-73 was well tolerated even at the highest tested dose of 55 mg. Study participants did not exhibit any serious side effects, nor was there any study discontinuation due to adverse events. In addition, ANAVEX 2-73 demonstrated a pharmacokinetics (PK) profile to potentially support once-daily oral dosing.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (OTCQX: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of novel drug candidates to treat central nervous system (CNS) diseases and various types of cancer. Anavex’s lead drug candidates, ANAVEX 2-73 and ANAVEX PLUS, the combination of ANAVEX 2-73 and donepezil (Aricept®), are 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 data 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 convulsive epileptic animal models, indicating its potential to treat additional CNS disorders, including epilepsy and others. The drug combination ANAVEX PLUS produced up to 80% greater reversal of memory loss in Alzheimer’s disease models versus when the drugs were used individually. 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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