Amarantus Outlines LymPro Alzheimer’s Diagnostic Development Strategy

SUNNYVALE, Calif.–(BUSINESS WIRE)– Amarantus BioScience Holdings, Inc. (OTCQB: AMBS), a biotechnology company discovering and developing treatments and diagnostics for diseases associated with neurodegeneration and apoptosis, today announced a development timeline for its LymPro Blood Test for Alzheimer’s disease (“LymPro”). LymPro is designed to diagnose Alzheimer’s disease by identifying immune-based biomarkers in the blood of Alzheimer’s patients, allowing physicians to definitively differentiate Alzheimer’s disease from other forms of dementia, a key unmet medical need in the management of Alzheimer’s patients. Human clinical studies for LymPro with over 160 patients have been completed to date, showing high sensitivity and specificity for Alzheimer’s disease diagnosis.

“The LymPro assay represents a blood-based peripheral means to assess the integrity of the regulatory function of the cellular machinery within the Central Nervous System,” said Amarantus corporate advisor Adam J. Simon, Ph.D. “Although we all experience various triggers and assaults on our brain as we age, why do some people succumb to Alzheimer’s while others show cognitive resilience? The LymPro test can potentially tell us who is susceptible to abnormal cell-cycle re-entry and who has sufficiently strong regulatory function in their neurons to arrest cell-cycle re-entry due to triggers such as age, diet, viral infection, stress, or brain injury that could eventually lead to Alzheimer’s disease.”

After establishing the analytical performance of the assay in an outsourced GLP laboratory, Amarantus plans to conduct a small clinical performance study at an independent laboratory in the second quarter of 2013 to verify the previously published findings. During the third quarter of 2013, the Company expects to initiate a pivotal diagnostic accuracy study (Phase 2) at the same independent laboratory to generate sufficient data to validate the clinical performance (sensitivity / specificity) that would support a CLIA launch, with data available in the first half of 2014. As part of that pivotal study, LymPro will be evaluated as an “aid to the diagnosis of Alzheimer’s disease.” The Company intends to initiate commercial worldwide sales following assessment of the validation study data. Thereafter, the Company intends to gain U.S. clearance or approval for the test through the Food and Drug Administration‘s de-novo Pre-market notification 510(k) or Premarket Approval (PMA) process, which would represent a 3-month to 2-year process. Ultimately, the Company believes LymPro could be approved by the FDA as a companion diagnostic product in combination with one or more therapeutic products.

“We are excited with the progress and upcoming activities related to our LymPro Alzheimer’s test, which addresses a market opportunity in excess of $500 million annually,” said Gerald E. Commissiong, President and Chief …read more

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