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Amarantus BioScience Licenses LymPro Alzheimer's Disease Diagnostic Blood Test
By: PR Newswire
Dec. 14, 2012 07:20 AM
SUNNYVALE, Calif., Dec. 14, 2012 /PRNewswire/ -- 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."
About Alzheimer's Disease
It is estimated that over 5.4 million people in the United States suffer from Alzheimer's disease and over 300,000 patients are diagnosed annually, with nearly one in eight older Americans affected by the disease. Alzheimer's is the sixth leading cause of death in the United States. The estimated cost of unpaid care in the United States is estimated at over $210 billion annually and the total payments for care are estimated at over $200 billion annually, including $140 billion in cost to Medicare and Medicaid. It is estimated that these figures will double by 2050. Amarantus believes the market opportunity for an effective Alzheimer's disease diagnostic far exceeds $500 million annually.
About Amarantus BioScience, Inc.
Amarantus BioScience, Inc. is a development-stage biotechnology company founded in January 2008. The Company has a focus on developing certain biologics surrounding the intellectual property and proprietary technologies it owns to treat and/or diagnose Parkinson's disease, Traumatic Brain Injury and other human diseases. The Company owns the intellectual property rights to a therapeutic protein known as Mesencephalic-Astrocyte-derived Neurotrophic Factor ("MANF") and is developing MANF-based products as treatments for brain disorders. The Company also is a Founding Member of the Coalition for Concussion Treatment (#C4CT), a movement initiated in collaboration with Brewer Sports International seeking to raise awareness of new treatments in development for concussions and nervous-system disorders. For further information please visit www.Amarantus.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about the possible benefits of MANF therapeutic applications and/or advantages presented by Amarantus' PhenoGuard technology, as well as statements about expectations, plans and prospects of the development of Amarantus' new product candidates. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including the risks that the anticipated benefits of the therapeutic drug candidates or discovery platforms, as well as the risks, uncertainties and assumptions relating to the development of Amarantus' new product candidates, including those identified under "Risk Factors" in Amarantus' most recently filed Annual Report on Form 10-K and Quarterly Report on Form 10-Q and in other filings Amarantus periodically makes with the SEC. Actual results may differ materially from those contemplated by these forward-looking statements Amarantus does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this presentation.
Amarantus Bioscience, Inc.
SOURCE Amarantus BioScience, Inc.
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