New York, NY – August 26, 2014 – Anavex Life Sciences Corp. (“Anavex” or the “Company”) (OTCQB: AVXL), a clinical-stage biopharmaceutical company developing novel drug candidates to treat Alzheimer’s disease, other diseases of the central nervous system (CNS) and various types of cancer, has selected The Alfred Hospital in Melbourne, Australia as the lead site for its upcoming Phase 2a clinical trial for ANAVEX 2-73, which is being developed as a potential disease-modifying treatment for Alzheimer’s disease. In total, the trial will involve up to seven experienced Alzheimer’s disease clinical trial sites in Melbourne. The clinical trial, including the commencement of patient recruitment, has been submitted to The Alfred Hospital’s Ethics Committee for approval.
“After a thorough review process including many international sites, we are very excited to be working with The Alfred Hospital, a world-renowned institution with significant experience in conducting Alzheimer’s clinical trials,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “The current Phase 2a trial is designed to be extremely efficient and embraces both adaptive trial features as well as population pharmacokinetics. This will enable the trial to determine the ANAVEX 2-73 dose and schedule that may provide the best therapeutic response with the least toxicity. We expect that positive results from the trial will provide a value inflection point for the Company and validate our drug candidates as a potentially effective treatments for Alzheimer’s disease and other neurological disorders.”
The Phase 2a clinical trial of ANAVEX 2-73 is scheduled to be an adaptive trial with repeated doses, maximum tolerated dose finding, pharmacodynamic investigation and bioavailability evaluation in patients with mild to moderate Alzheimer’s disease with a six-month open label follow-up period. The trial is expected to involve a total of 32 patients. The primary and secondary endpoints are maximum tolerated dose and relationship between dose and efficacy outcomes measured through MMSE, ADSC-ADL, computerized cognitive tests and electroencephalography/event-related potentials (EEG/ERP).
The study’s principal investigator will be Dr. Stephen Macfarlane, FRANZCP, Associate Professor and Director of Aged Psychiatry at The Alfred Hospital. Dr. Macfarlane has extensive experience conducting Alzheimer’s disease clinical trials. With a wealth of knowledge and expertise amassed over a career spanning more than 25 years, Professor Macfarlane remains abreast of trends and developments in his field as Chair of the Victorian Faculty of Old Age Psychiatry and Secretary of the Binational faculty of Old Age Psychiatry within The Royal Australian and New Zealand College of Psychiatrists
“ANAVEX 2-73 is a potentially promising new treatment for Alzheimer’s disease,” said Dr. Macfarlane. “A therapeutic that is safe and could be an add-on therapy to standard of care (donepezil) with convenient oral administration would obviously be a big step forward, given the currently limited treatment options in Alzheimer’s disease.”
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 pre-clinical data indicating that ANAVEX 2-73 has the potential to prevent, halt and/or reverse the course of Alzheimer’s disease, there was also 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 The Alfred Hospital
The Alfred Hospital is a major tertiary referral teaching hospital. It has a major role in the provision of specialist tertiary and quaternary services on a statewide and national basis. Specialist services include trauma services, emergency and intensive care, comprehensive cancer services, blood diseases, respiratory medicine, melanoma, bone marrow transplant, cardiology / cardiovascular services, neurosurgery, general and specialist surgery and medicine, psychiatry and diagnostic services. Founded in 1871, The Alfred Hospital is the oldest Melbourne hospital that is operating on its original site. Since that time, The Alfred Hospital has been recognized as a pacesetter in the national medical arena and has consistently been linked to progressive developments in acute care, medical research and health care teaching. The Alfred Hospital provides acute and mental health care services to the residents of the local municipalities to meet the health needs of the local community. These services are provided in a range of inpatient and ambulatory settings and in partnership with other community providers.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (www.anavex.com) is a clinical-stage biopharmaceutical company engaged in the development of novel drug candidates to treat Alzheimer’s disease, other CNS diseases and various types of cancer. ANAVEX 2-73, an orally available drug candidate developed to treat Alzheimer’s disease through potential disease modification, has undergone an initial Phase 1 human clinical trial and was well tolerated in doses up to 55mg. Results from preclinical studies indicate that ANAVEX 2-73 demonstrates anti-amnesic and neuroprotective properties. A highly encouraging synergistic effect has also been 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. Anavex is a publicly traded corporation quoted as AVXL.
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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