Anavex Life Sciences’ Drug Shows Efficacy to Support Potential Disease Modification in Parkinson’s Disease

NEW YORK, Sept. 22, 2016 -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (AVXL) today presented preclinical data demonstrating that ANAVEX 2-73, a sigma-1 receptor agonist, restores function in a classic animal model of Parkinson’s disease. Significant improvements were seen on all measures: behavioral, histopathological, and neuroinflammatory endpoints.

 

Veronica Francardo, PhD, and Angela Cenci, PhD, main authors of the study at Lund University, Sweden, commented: “We are in the fortunate situation that safety and tolerability of this compound have already been proven in human subjects, and that preliminary indications of a cognitive benefit have been obtained in a Phase 2a clinical trial for Alzheimer’s disease.”

Dosing of ANAVEX 2-73 daily for five weeks in a 6-hydroxydopamine lesions mouse model of Parkinson’s disease was followed by a battery of standardized tests that are linked to parkinsonian motor symptoms. The data indicates that ANAVEX 2-73 is well tolerated, induces significant motor recovery (p<0.05), induces neurohistological restoration (p<0.05) and reduces microglial activation (p<0.05), a potential biomarker of Parkinson’s disease. Behavioral patterns were completely normal, meaning no signs of either dystonia or stereotypic behaviors were detected in animals receiving the treatment. Further analyses are ongoing to confirm the neuroprotective effects of the compound and possibly elucidate some of the underlying mechanisms that contribute to the disease-modifying properties of ANAVEX 2-73. The study is funded by The Michael J. Fox Foundation for Parkinson’s Research.

 

Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex, stated, “This initial data is encouraging, and together with already available clinical safety and tolerability data on ANAVEX 2-73, might accelerate the exploration of ANAVEX 2-73 as a potential therapeutic intervention in Parkinson’s disease.”

 

The data is presented at the World Parkinson Congress 2016 in Portland, Oregon by Veronica Francardo, PhD, from Lund University, Sweden, titled “Investigating the potential neurorestorative effects of a clinical Sigma-1 receptor agonist in a mouse model of Parkinson’s disease”. The poster presentation is available on the publications page of Anavex’s website.

 

Parkinson’s disease is a progressive disease of the nervous system marked by tremors, muscular rigidity, and slow, imprecise movement. It is associated with degeneration of the basal ganglia of the brain and a deficiency of the neurotransmitter dopamine. Parkinson’s disease afflicts more than 10 million people worldwide, typically middle-aged and elderly people.

 

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 $600 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 ground breaking 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 The World Parkinson Congress 2016

The World Parkinson Congress (WPC) is a triennial event with the 2016 edition marking the 4th such meeting since its inception in 2006. As in years past the mission of the WPC is to provide an international forum to disseminate the latest scientific discoveries, medical practices, caregiver initiatives and advocacy work relevant to Parkinson's disease.  In doing so each Congress facilitates a worldwide dialogue to expedite the discovery of best treatment practices for this devastating condition. This year’s meeting takes place on September 20-23, 2016 at the Oregon Convention Center in Portland, Oregon and includes sessions on fundamental science as well as translational and clinical research.

 

 

About Anavex Life Sciences Corp.

Anavex Life Sciences Corp. (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 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.

 

Forward-Looking Statements

 

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.