Amarantus BioScience, Inc. (OTCQB: AMBS), a biotechnology company discovering and developing treatments for diseases associated with protein misfolding and apoptosis, today announced that it has licensed the LymPro Alzheimer's Disease Diagnostic Blood Test (LymPro) from Memory Dx, LLC (MDx), formerly known as Provista Life Sciences, Inc. LymPro originated from the University of Leipzig in Germany and has received over $3 million in research grants from the National Institutes of Health (NIH).
LymPro was designed with the purpose of diagnosing Alzheimer's in its mild to moderate stage, a population of patients currently being tested in numerous clinical studies with amyloid-beta targeting strategies. LymPro works by identifying immune-based biomarkers in the blood of Alzheimer's patients, diagnosing Alzheimer's and allowing physicians to definitively differentiate Alzheimer's disease from other forms of dementia. This patient-specific identification has the potential to become an invaluable tool for Alzheimer's disease clinical trials, where there has been a well-documented history of patient recruitment errors related to inaccurate diagnosis of Alzheimer's. LymPro has completed two Phase 1 clinical studies in over 80 patients, showing 98% sensitivity and 96% specificity for Alzheimer's disease diagnosis. LymPro is ready to move into a Phase 2 validation study. If successful, LymPro can begin generating revenue as a laboratory developed test ("LDT") within 18 months of study initiation through commercial sales and through sales to companies performing Alzheimer's disease clinical research.
"We believe LymPro has significant clinical and commercial potential as a diagnostic blood test for Alzheimer's disease," said Gerald E. Commissiong , President and CEO of Amarantus. "It is clear that the path forward for treating Alzheimer's disease is to identify and initiate therapeutic intervention as early as possible. If proven effective, LymPro could provide physicians with a lower-cost, minimally-invasive intervention and reduce the need for costly brain imaging scans. This license expands our diagnostic pipeline and complements our strategic focus on neurodegenerative diseases. While we are not currently developing MANF for Alzheimer's disease, we believe that the cost-effective definitive identification of earlier-stage patients will create a significant opportunity for Amarantus to evaluate the MANF Program as a disease-modifying treatment in this large, underserved therapeutic indication."
Under the terms of the agreement, Amarantus has agreed to issue two million shares of restricted common stock to MDx, pay a development milestone upon successful completion of the Phase 2 validation study, as well as pay a nine percent royalty on sales. In addition, Amarantus has agreed to retain MDx to perform the necessary validation study to gain Clinical Laboratory Improvement Amendments (CLIA) certification for LymPro. Together, Amarantus and MDx will expand their relationships with large pharmaceutical companies, and will also seek additional grant funding for the further development of LymPro. Amarantus has the right to assign or sub-license LymPro to a third party of its choosing at any time.
"Amarantus represents an excellent partner for Memory Dx because of its scientific focus on protein misfolding and aggregation, which we believe will continue to be critical in developing disease-modifying treatments for Alzheimer's," said William E. Gartner , President and CEO of Memory Dx, LLC. "This agreement with Amarantus is the final step in the transition of Memory Dx from a diagnostic product developer into a contract CLIA lab focused on driving revenues. We look forward to working with Amarantus to advance LymPro and get it into the hands of physicians so we can help address the significant socioeconomic problems caused by Alzheimer's disease."
Amarantus BioScience, Inc.