ANAVEX 2-73 advances Phase I clinical trial for Alzheimers disease
May 26, 2011
Hoboken, NJ May 23, 2011 -- Anavex Life Sciences Corp. (Anavex) (OTCBB: AVXL) is pleased to provide an update on its ongoing Phase I clinical trial to evaluate ANAVEX 2-73, the companys lead candidate for Alzheimers disease. After reviewing all the safety data from the first group of healthy human volunteers in the initial dose step, the Safety Review Committee for ANAVEX 2-73 unanimously approved skipping the 5 mg dose and moving directly to the 10 mg dose step. The next group of eight healthy volunteers was dosed late last week. The clinical trial protocol allowed for the next dose to be studied as either 5 mg or 10 mg, if the safety review warranted the higher dose.
We are very pleased with the clinical trial data results to date for the safety profile of ANAVEX 2-73, said Dr. Angelos Stergiou, Vice President of Clinical Development and Medical Affairs for Anavex. Our Safety Review Committee meets regularly to discuss and review the clinical trial data in a blinded manner. Following an extensive review of the current results, the Safety Review Committee was confident in allowing us to move directly into the 10 mg dose step.
I am honored to be the Principal Investigator and a member of the Safety Review Committee for this potential disease-modifying drug, ANAVEX 2-73, in Alzheimers disease. The healthy volunteers to date have been successfully dosed according to the study protocol at the Technical University of Dresden and there has been no evidence at all to date of any treatment-related adverse effects. Our Safety Review Committee has reviewed and discussed all data in detail and agreed to proceed to the 10 mg dose stage. With such promising preclinical data I am hopeful that we can continue to advance ANAVEX 2-73 through its development path, said PD Dr. Christoph Schindler, MD, of the Technical University of Dresden.
The Safety Review Committee is comprised of the following members: PD Dr. Christoph Schindler, Clinical Pharmacologist and Principal Investigator for the ANAVEX 2-73 Phase I clinical trial at the Medical Faculty of the Technical University of Dresden, Dr. Juergen Wurziger, MD, the study physician on behalf of ABX-CRO, the Clinical Research Organization running the trial, and Dr. Angelos Stergiou, MD, the responsible study physician for Anavex Life Sciences.
To make its decision, the Safety Review Committee assessed all of the following safety data to date in a blinded manner:
- Laboratory reports of safety data as described in the protocol up to 48 hours (day three) after dosing
- Electrocardiograph (ECG) and vital data as described in the protocol up to 48 hours (day three) after dosing
- A summary on any adverse events that occurred in this dosing group
- Each volunteer is contacted by phone for a further safety check on day seven following drug administration
The Phase I clinical trial is being conducted in Germany in collaboration with ABX-CRO, which has conducted several Alzheimers disease studies, and the Technical University of Dresden. Dosing of at least 16 healthy human volunteers is expected to be completed in approximately two months as per the trial protocol.
About the ANAVEX 2-73 Phase I Clinical Trial
This Phase I clinical trial is a randomized, placebo-controlled study to initially test ANAVEX 2-73 as a single, ascending oral dose in healthy volunteers. The trial seeks to determine the maximum tolerated single dose, safety, pharmacokinetics (the mechanisms of absorption and distribution of the drug, the rate at which a drug begins to act and the duration of its effect, as well as chemical changes of the substance in the body).
About Alzheimers Disease
While Alzheimers disease is most common in people over the age of 65, it can strike adults of any age irrespective of their gender, background or socioeconomic status. According to the Alzheimers Association, an estimated 5.4 million Americans are currently living with Alzheimers disease. The number of Americans aged 65 and over with Alzheimers is estimated to reach 7.7 million in 2030. This represents a 50 percent increase from the 5.2 million Americans aged 65 and older who are currently affected. The Alzheimers Association further projects that the number of Americans aged 65 and older who are affected by Alzheimers disease may triple to between 11 and 16 million by 2050 unless there are developments to prevent or more effectively treat the disease.
About ANAVEX 2-73
ANAVEX 2-73 is the first of a new class of oral, disease-modifying drugs being studied to potentially treat Alzheimers disease itself, versus treating its symptoms.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (www.anavex.com) is a specialty pharmaceutical company engaged in the discovery and development of novel drug candidates for the treatment of neurological diseases and cancer. The Anavex proprietary SIGMACEPTOR Discovery Platform involves the rational design of drug compounds targeted to specific receptors involved in the modulation of multiple cellular biochemical signaling pathways.
The SIGMACEPTOR-N program involves the development of novel drug candidates that target neurological and neurodegenerative diseases (Alzheimer's disease, epilepsy, depression, pain). The company's lead drug candidates exhibit high affinity for sigma receptors, which have been extensively documented as potentially valuable drug targets and have demonstrated anti-amnesic and neuroprotective properties. A portfolio of back-up compounds to ANAVEX 2-73 are also in development.
Anavex is a publicly traded company under the symbol 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. Forward-looking statements in this press release include that dosing of at least 16 healthy human volunteers is expected to be completed in approximately two months as per the trial protocol, that ANAVEX 2-73 is the first of a new class of oral, disease-modifying drugs which could potentially treat Alzheimers disease and that we can continue to advance ANAVEX 2-73 through its development path. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug discovery and development, which include, without limitation, the potential failure of development candidates to advance through preclinical studies or demonstrate safety and efficacy in clinical testing and the ability to pass clinical trials so as to move on to the next phase, our ability to retain key employees and our ability to finance development or satisfy the rigorous regulatory requirements for new drugs. Competitors may develop better or cheaper alternatives to our products. 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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