The ATTENTION-AD extension study will offer the 450 patients enrolled in the on-going Phase 2b/3 ANAVEX®2-73 73 (blarcamesine) Early Alzheimer’s disease study the opportunity to continue their treatment for an additional two years and will provide additional tolerability and efficacy data
NEW YORK, Oct. 09, 2019 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) diseases, today announced the initiation of the ATTENTION-AD, a long-term extension study for patients with Early Alzheimer’s disease and treated with ANAVEX®2-73 (blarcamesine).
The ATTENTION-AD study (Open Label Extension Study for Patients with Early Alzheimer’s Disease (AD) Enrolled in Study ANAVEX2-73-AD-004), which is an extension of the Phase 2b/3 ANAVEX®2-73-AD-004 clinical study currently underway, will give AD patients an opportunity to continue their treatment. This study is expected to last two years for patients included in the ANAVEX®2-73-AD-004 study, once they have completed the placebo-controlled 48-week Phase 2b/3 trial.
ATTENTION-AD will be conducted in parallel with the Phase 2b/3 ANAVEX®2-73-AD-004 study.
All patients who participate in the Phase 2b/3 ANAVEX®2-73-AD-004 study will be eligible to participate also in the ATTENTION-AD study under a voluntary open label extension protocol.
“This is an important development as the patients who have completed the main study, ANAVEX2-73-AD-004, are consistently expressing the wish to gain ongoing access to this investigational therapy,” says A/Professor Stephen Macfarlane, FRANZCP, Head of Clinical Services at the Dementia Centre, HammondCare and Principal Investigator for both studies.
“People living with Alzheimer’s disease desperately need new therapies and ATTENTION-AD reflects our commitment to the patients who participated in the Phase 2b/3 ANAVEX®2-73-AD-004 study and who have contributed enormously to the development of a potential new medicine for patients with Early Alzheimer’s disease,” said Christopher U Missling, PhD, Chief Executive Officer of Anavex. “This study will provide supplemental data on ANAVEX®2-73 (blarcamesine).”
About Alzheimer’s Disease
Alzheimer's disease is a progressive, irreversible neurological disease and the most common cause of dementia. In the U.S., there are over five million individuals living with Alzheimer's disease and an estimated 50 million people live with dementia worldwide. Today, there are no commercially available therapies to address the underlying cause of Alzheimer's. According to the World Alzheimer Report 2019, the current annual cost of dementia is estimated at $1 trillion, a figure set to double by 2030.1
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 disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) diseases, pain and various types of cancer. Anavex’s lead drug candidate, ANAVEX®2-73 (blarcamesine), recently completed a successful Phase 2a clinical trial for Alzheimer’s disease. ANAVEX®2-73 (blarcamesine) is an orally available drug candidate that restores cellular homeostasis by targeting sigma-1 and muscarinic receptors. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease. ANAVEX®2-73 (blarcamesine) also exhibited anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy. The Michael J. Fox Foundation for Parkinson’s Research previously awarded Anavex a research grant, which fully funded a preclinical study to develop ANAVEX®2-73 (blarcamesine) for the treatment of Parkinson’s disease. ANAVEX®3-71, which targets sigma-1 and M1 muscarinic receptors, is a promising preclinical drug candidate demonstrating disease-modifying activity against the major hallmarks of Alzheimer’s disease in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid and tau pathologies. In preclinical trials, ANAVEX®3-71 has shown beneficial effects on mitochondrial dysfunction and neuroinflammation. Further information is available at www.anavex.com. You can also connect with the company on Twitter, Facebook and LinkedIn.
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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