NEW YORK, NY – August 10, 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, today announced that it has been awarded a research grant from The Michael J. Fox Foundation for Parkinson’s Research (MJFF) to develop ANAVEX 2-73 for the treatment of Parkinson’s disease.
The MJFF grant is expected to fully fund a preclinical study on the effect of ANAVEX 2-73 in a Parkinson’s disease animal model, which seeks to provide a solid dataset that will justify moving forward to clinical development in Parkinson’s. The study may also provide further evidence for the involvement of sigma-1 receptors in potentially disease-modifying therapies for Parkinson’s disease.
As a potential platform drug and the Company’s lead therapeutic, ANAVEX 2-73 targets misfolded proteins central to many neurodegenerative diseases, including Parkinson’s and Alzheimer’s. It is believed to enhance the body’s own cellular defense mechanisms through both sigma-1 and muscarinic receptors to return diseased cells to a pre-diseased or “homeostatic” state.
“The development of disease-modifying therapies for Parkinson’s disease is the top priority of The Michael J. Fox Foundation and ANAVEX 2-73 presents a promising approach,” said Marco Baptista, PhD, Senior Associate Director of MJFF Research Programs. “Companies that receive funding from MJFF have scientifically compelling plans that hold obvious potential to impact our understanding of Parkinson’s and ultimately the development of improved treatments for people with the disease. To that end, we look forward to the results of the ANAVEX 2-73 study.”
“If successful, this study will accelerate the translation of preclinical findings into the very first clinical trial of ANAVEX 2-73 as a potential disease-modifying therapy for Parkinson’s disease,” said Angela Cenci, MD, PhD, and Professor at Lund University, where the study will be conducted. “We are in the fortunate position that ANAVEX 2-73 has already been tested for safety and tolerability in humans, and was found to be a good clinical drug candidate.”
“Anavex is honored to have The Michael J. Fox Foundation for Parkinson’s Research support the development of our technology and we are pleased to be collaborating with such a prestigious organization,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “We hope this research will lead to improved therapies that can maximize the benefits and minimize side effects for Parkinson’s patients. After reporting positive initial data last month in our ongoing ANAVEX 2-73 Phase 2a clinical trial in Alzheimer’s patients, we expect the trial to be fully enrolled and to have PART A completed by the end of the year. Our work with MJFF underscores our unwavering commitment to delivering new medications for neurological disorders characterized by deposits of misfolded proteins, including both Parkinson’s and Alzheimer’s diseases.”
The preclinical study of ANAVEX 2-73 in Parkinson’s disease will be conducted at Lund University in Sweden under supervision of Professor Angela Cenci, MD, PhD.
About Parkinson’s Disease
Parkinson’s disease is a chronic and progressive neurological disorder that is characterized by well-known motor symptoms including tremors, stiffness of limbs, slowness of movements, and difficulties with posture and balance, as well as by non-motor symptoms. It is the second most common neurological disorder and approximately one million people in the United States, and from four to six million people worldwide, live with this disease. Parkinson’s disease is more common in people over 60 years of age and its prevalence is expected to increase significantly as the average age of the population increases. Current Parkinson’s treatments are only effective in managing symptoms of the disease, mainly through the use of levodopa and dopamine agonists. As the disease progresses and dopaminergic neurons continue to be lost, these drugs eventually become less effective at treating the symptoms.
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. It is currently undergoing a Phase 2a clinical trial for Alzheimer’s disease. A Phase 1 trial was successfully completed and showed no safety issues or toxicity signals. In the Phase 1 trial, 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. 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 The Michael J. Fox Foundation for Parkinson’s Research
As the world’s largest nonprofit funder of Parkinson’s research, The Michael J. Fox Foundation is dedicated to accelerating a cure for Parkinson’s disease and improved therapies for those living with the condition today. The Foundation pursues its goals through an aggressively funded, highly targeted research program coupled with active global engagement of scientists, Parkinson’s patients, business leaders, clinical trial participants, donors and volunteers. In addition to funding more than $450 million in research to date, the Foundation has fundamentally altered the trajectory of progress toward a cure. Operating at the hub of worldwide Parkinson’s research, the Foundation forges groundbreaking collaborations with industry leaders, academic scientists and government research funders; increases the flow of participants into Parkinson’s disease clinical trials with its online tool, Fox Trial Finder; promotes Parkinson’s awareness through high-profile advocacy, events and outreach; and coordinates the grassroots involvement of thousands of Team Fox members around the world.
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. 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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