Anavex Life Sciences Corp. (“Anavex”) (OTCBB: AVXL) today announced that the first healthy human volunteers have been initially dosed in its Phase I clinical trial to evaluate ANAVEX 2-73, the company’s lead compound for Alzheimer’s disease.
“We are pleased that the first volunteers have been dosed with the study drug, according to the study protocol, and no adverse events have been recorded post dosing to date," said Dr. Ozkan Yalkinoglou, Medical Director of ABX-CRO.
“ANAVEX 2-73 is a proprietary, wholly owned drug that comes from a family of compounds discovered and developed in-house. Its first-in-human administration is the most significant and important milestone in our corporate history. We eagerly anticipate the results of this Phase I clinical trial,” said Dr. Cameron Durrant, Executive Chairman of Anavex.
“There is a significant need for new and effective oral treatments for Alzheimer’s disease. Based on several preclinical animal studies, we believe ANAVEX 2-73 is a promising new anti-Alzheimer’s compound that has the potential to directly address the pathology of Alzheimer’s disease, potentially halting or even reversing its course,” said Dr. Angelos Stergiou, Vice President of Clinical Development & Medical Affairs for Anavex.
The Phase I clinical trial is being conducted in Germany in collaboration with ABX-CRO, which has conducted several Alzheimer’s disease studies, and the University of Dresden. Dosing of at least 16 healthy volunteers is expected to be complete in approximately three months.
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) and pharmacodynamics (physiological effects of drugs on the body, mechanisms of action and relationship between drug concentration and effect).
About Alzheimer’s Disease
While Alzheimer’s 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 Alzheimer’s Association, an estimated 5.4 million Americans are currently living with Alzheimer’s disease. The number of Americans aged 65 and over with Alzheimer’s 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 Alzheimer’s Association further projects that the number of Americans aged 65 and older who are affected by Alzheimer’s 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 Alzheimer’s disease itself, versus treating its symptoms.