New York — January 12, 2015 — Anavex Life Sciences Corp. (“Anavex” or the “Company”) (OTCQX: AVXL) today announced dosing of the first patient in the Phase 2a clinical trial of ANAVEX 2-73 and ANAVEX PLUS, which are being developed as an oral therapy and oral drug combination for the potential treatment of Alzheimer’s disease. In preclinical studies, ANAVEX 2-73 was shown to prevent, halt and/or reverse Alzheimer’s disease by targeting sigma-1 and muscarinic receptors. The drug therapeutic showed no serious adverse events in a successfully completed Phase 1 human study.
“Dosing the first patient is an exciting milestone for Anavex and we plan to report the topline results of this Phase 2a study by the third quarter of 2015,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “With its adaptive design, the aim of this trial is to objectively measure all possible effects of the drug in patients, which serves to optimally design and reduce the risk for future pivotal trials. There is an urgent, unmet need in Alzheimer’s disease, with a new case developing every 67 seconds and 5.2 million Americans currently diagnosed. We believe ANAVEX 2-73 and ANAVEX PLUS may effectively address this unmet need as potential symptomatic and possibly disease-modifying Alzheimer’s therapies.”
In this multicenter Phase 2a adaptive clinical trial of ANAVEX 2-73 and ANAVEX PLUS, at least 32 mild to moderate Alzheimer’s patients will be enrolled and they will be able to receive the study drug for up to 26 weeks. The primary objective of the trial is to evaluate the maximum tolerated dose of ANAVEX 2-73 in these patients. Additional trial objectives include dose response, bioavailability, cognitive efficacy and the relationship of ANAVEX 2-73 as an add-on therapy to donepezil, the current standard of care. Additional information regarding the trial is available from the U.S. National Institutes of Health (NIH) clinical trials database at www.clinicaltrials.gov.
About ANAVEX 2-73 and ANAVEX PLUS
ANAVEX 2-73 is an orally available small molecule being investigated for the treatment of Alzheimer’s disease. In addition to preclinical data indicating that ANAVEX 2-73 has the potential to prevent, halt and/or reverse the course of Alzheimer’s disease, there was a highly encouraging synergistic effect observed between ANAVEX 2-73 and donepezil (Aricept®). The combined therapeutic, called ANAVEX PLUS, produced up to 80% greater reversal of memory loss in Alzheimer’s disease models versus when the drugs were used individually.
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 Alzheimer’s disease, other 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. 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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