Partnering on pharmacodynamics

SAN FRANCISCO, GENEVA & NEW YORK—Biotechnology company Amarantus BioScience Holdings Inc. and Anavex Life Sciences Corp. are uniting their efforts in a biomarker services agreement, under which Amarantus will evaluate ANAVEX 2-73 and ANAVEX PLUS (a combination of ANAVEX 2-73 and donepezil) to determine their pharmacodynamic effect on the expression of the CD69 biomarker in certain sub-populations of peripheral blood lymphocytes using LymPro Test, its proprietary Alzheimer's disease blood diagnostic.

In conjunction with this agreement, Amarantus and Anavex have also established a Letter of Intent by which Amarantus will aid Anavex in planning the scope of the blood-based biomarker components for Anavex' next larger, potentially Phase 3 Alzheimer's disease clinical trial. That trial is expected to follow the company's ongoing Phase 2a study, which is currently enrolling subjects to collect further safety and exploratory efficacy data in patients with mild to moderate Alzheimer's disease. Initial data is expected in the third quarter of this year.

Gerald E. Commissiong, president and CEO of Amarantus, noted that previous data and completed studies have shown that “CD69 expression as measured by LymPro is decreased in patients with AD, as compared to healthy controls and patients with confounding dementias. The ability of a new drug candidate to increase CD69 expression, as measured by LymPro, may be indicative of a modification in the fundamental Alzheimer's disease process known as cell cycle dysregulation (a/k/a 'ectopic cell cycle re-entry'). Cell cycle dysregulation has been directly implicated as a key driver of the neuronal death in the areas of the brain affected by AD that is triggered by amyloid beta signaling through Tau.”

The company recently completed 'Fit-for-Purpose' assay validation of LymPro at Icon Central Laboratories, which allows the assay to be offered for investigational use only to evaluate pharmacodynamic changes in CD69 expression, as well as patient screening and pharmacodynamics drug monitoring in therapeutic Alzheimer's disease clinical trials.

“Our premier diagnostics division, Amarantus Diagnostics, is well positioned to add value to pharmaceutical companies' Alzheimer's therapeutics programs by helping them better execute AD therapeutic clinical studies,” Commissiong added. “We will assist companies by enriching the population of subjects enrolling in Alzheimer's clinical studies, the key unmet need for therapeutic Alzheimer's programs, as well as evaluating drug activity of cell cycle dysregulation, and potentially lipidomics and exosomes via an exclusive option agreement the Company currently holds with Georgetown University. We are currently in active discussions with both emerging and large pharma companies as we work to build a significant customer base for blood-based biomarker services in Alzheimer's disease, with the ultimate shared goal of improving the current standard of care used to treat AD. We are positioning Amarantus Diagnostics to be the market leader in Alzheimer's blood-based biomarkers for the Investigational Use Only market, and we believe this agreement is the first important revenue generating step in this direction for Amarantus."

“While the Phase 2a clinical trial for ANAVEX 2-73 and ANAVEX PLUS in Alzheimer's disease is currently underway, Anavex is already planning and exploring options for the next stage of clinical trials, potentially Phase 3, for ANAVEX 2-73 and ANAVEX PLUS given the high unmet need in Alzheimer's,” Dr. Christopher U. Missling, president and CEO for Anavex, noted in a statement. “ANAVEX 2-73 has demonstrated in preclinical studies to block Tau and amyloid-beta proteins and memory deficits by targeting mixed muscarinic and Sigma-1 receptors, targets which are further 'upstream' in the Alzheimer's disease cascade and thus its potential to halt and/or reverse the course of AD. Being an orally available drug candidate combined with a favorable safety profile as established in a recently completed Phase 1 clinical study of ANAVEX 2-73, we are looking forward to collecting continued safety data and exploratory efficacy data in patients. Assuming a successful Phase 2a outcome, we will evaluate the scope of blood-based biomarker services that could be included in the design for our next AD clinical studies for ANAVEX 2-73 and ANAVEX PLUS.”