Anavex Life Sciences Corp. (“Anavex”) (OTCBB: AVXL) today commented on new diagnostic criteria and guidelines for Alzheimer’s disease published recently by the National Institute on Aging (NIA) and the Alzheimer’s Association, which have been updated for the first time in more than 25 years. The new guidelines discuss the importance of new technologies, including brain imaging and biomarker analysis, in research and clinical diagnosis. They describe Alzheimer’s disease at a preclinical stage, Mild Cognitive Impairment (MCI) due to Alzheimer’s disease, and dementia due to Alzheimer’s pathology.
“Anavex wholeheartedly supports the new guidelines and the emphasis on looking at preclinical markers. Although clinical signs do not typically manifest until later in the disease process, experts increasingly agree that the underlying causes of Alzheimer’s disease may begin early on,” said Dr. Cameron Durrant, Executive Chairman of Anavex. “The guidelines also state that some older people are found to have amyloid-beta plaques in their brain at autopsy, even though they did not demonstrate clinical signs of Alzheimer’s disease during their lives. Moving research interventions upstream in the process, which has always been the Anavex approach, offers the possibility to reverse or halt the course of the disease at the very earliest stages of its development.”
In recent decades, researchers seeking new drugs to treat the underlying causes of Alzheimer’s disease have focused their efforts on amyloid-beta plaques, which are clumps of protein that appear on the brain of many individuals who have Alzheimer’s disease. Several of these drug candidates have failed in clinical trials.
“While it has been shown that amyloid deposits likely begin early in the disease process, it seems that loss of neurons occurs at a later stage and may accelerate just before clinical symptoms appear,” said Dr. Angelos Stergiou, Vice President of Clinical Development & Medical Affairs for Anavex. “Anavex continues to believe that we need to look past amyloid plaques as being the cause of Alzheimer's disease and that they are more likely to be a consequence of the underlying disease process, akin to a defense mechanism. Tackling upstream causes early in the disease process as we are doing with ANAVEX 2-73, our lead drug candidate currently in Phase I clinical trials, could prove to be an important strategy which may potentially even be a preventive approach. Furthermore, we plan on enrolling patients with MCI due to Alzheimer’s and will perform biomarker tests as we feel this type of approach will become the benchmark for the diagnosis of this debilitating disease.”
The three stages covered in the new NIA/Alzheimer’s Association guidelines are:
- Preclinical Alzheimer’s disease, which applies only in a research setting and describes the stage when changes to the brain may already be underway. Amyloid plaques can be detected in some people using PET scans and cerebrospinal fluid analysis, however their risk for progression to Alzheimer’s dementia is unknown.
- Mild Cognitive Impairment is evidenced by memory problems that can be noticed and measured but which do not compromise a person’s independence. People with MCI may or may not develop Alzheimer’s disease, although it is likely that everyone who eventually develops Alzheimer’s disease has previously had MCI.
- Alzheimer’s Dementia is the final disease stage. Guidelines detail the ways that healthcare professionals should evaluate the causes and evolution of cognitive decline.
Additional information about the new diagnostic criteria and guidelines for Alzheimer’s disease is available on the Alzheimer’s Association web site: http://www.alz.org/research/diagnostic_criteria/.
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.
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