Trial Extension Granted at Request of Patients and Caregivers
NEW YORK, NY – March 10, 2016
Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL) today announced that the Company has received the approval from the Ethics Committee in Australia to extend the ongoing Phase 2a Alzheimer’s trial, which had been requested by patients and their caregivers. The trial extension is designed to allow participants who complete 52 weeks in PART B to roll-over into a new trial and continue taking ANAVEX 2-73 for an additional 104 weeks, providing an opportunity to gather extended safety and efficacy data. The trial is independent of the Company’s planned larger Phase 2/3 double-blinded, placebo-controlled study of ANAVEX 2-73 in Alzheimer’s disease.
“We are receiving continued positive feedback about the effects of ANAVEX 2-73 from our study participants and their caregivers,” said Associate Professor Stephen Macfarlane, FRANZCP, Director of Aged Psychiatry at Alfred Health and the Principal Investigator of the study. “In addition to the measured cognitive and functional benefits witnessed so far, an overall improvement in mood and decrease in agitation has been anecdotally reported. We believe that extending the study will lead us to an increased understanding of the long-term effects of ANAVEX 2-73.”
The company will also present detailed dose-response analysis of data from the ongoing Phase 2a Alzheimer’s trial of ANAVEX 2-73 PART A at the 14th International Symposium on Advances in Alzheimer Therapy (AAT), which will be presented by Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex, at 12:20 p.m. Eastern European Time (5:20 a.m. Eastern Time) on Saturday, March 12, 2016. Presentation slides will be made available on the Anavex website at the time of the presentation.
The findings will include:
Despite the relative small sample size of this proof-of-concept randomized open-label study, dose-response analysis seems to indicate that in 32 patients treated with doses of ANAVEX 2-73 ranging from 3 mg (IV) to 50 mg (oral) per day, both the MMSE-Δ and the ERP/P300 data showed a positive slope with confidence intervals not including the zero-value, consistent with a dose dependent improvement in MMSE scores over five weeks.
Low-High dose was statistically significant to affect MMSE-Δ and ERP-Δ scores with MMSE-Δ (p=0.0285) and ERP-Δ (p=0.0168), respectively. Results were confirmed by Bayesian and bootstrap analyses.
A minimum dose of 14 mg of ANAVEX 2-73 seem to be required to achieve a therapeutic effect and to keep MMSE score unchanged.
Similar positive MMSE score effect and no notable difference between ANAVEX 2-73 alone and ANAVEX 2-73 with donepezil (ANAVEX PLUS) were observed.
“Safety is a key requirement for a potential drug approval and we believe that this extension, which is now already the second of this trial, is an important step forward for patients, caregivers and physicians, who have asked for continued access to ANAVEX 2-73,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “While we are waiting for longitudinal effect data of ANAVEX 2-73 over an extended period of time, the positive dose-response in PART A is an encouraging step and also consistent with the fast mode of action of the sigma-1 receptor.“
About the 104-Week ANAVEX 2-73 Phase 2a Extension Study
The multi-center Phase 2a clinical trial of ANAVEX 2-73 consists of an open-label extension for an additional 104 weeks, allowing for the gathering of safety data for ANAVEX 2-73 cumulatively over three years.
The new 104-week (two-year) extension of the multi-center Phase 2a clinical trial of ANAVEX 2-73 will follow patients with mild-to-moderate Alzheimer’s disease who have already completed 52 weeks in PART B of the study. Every three months, patients will be scheduled for physician visits to assess primary and secondary endpoints.
The primary endpoint of the new Phase 2a trial is to establish continued safety and tolerability of ANAVEX 2-73. Secondary endpoints are exploratory cognitive as well as functional measures using Mini Mental State Examination (MMSE) and evaluation of Alzheimer’s Disease Co-operative Study – Activities of Daily Living Inventory (ADCS-ADL), respectively.
Additional information regarding the ongoing Phase 2a 52-week clinical study as well as the new 104-week Phase 2a study is available from the U.S. National Institutes of Health (NIH) clinical trials database at www.clinicaltrials.gov.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of differentiated therapeutics for the treatment of neurodegenerative 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 convulsive epileptic animal models, indicating its potential to treat additional CNS disorders, including epilepsy and others. The Michael J. Fox Foundation (MJFF) for Parkinson’s Research has awarded Anavex a research grant to develop ANAVEX 2-73 for the treatment of Parkinson’s disease by fully funding 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.
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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