Amarantus Amends LymPro LP-002 Clinical Protocol to Report Interim Data at #C4CT Presentation
SAN FRANCISCO and GENEVA, July 30, 2014 (GLOBE NEWSWIRE) -- Amarantus Bioscience Holdings, Inc. (OTCQB:AMBS), a biotechnology company focused on the discovery and development of novel diagnostics and therapeutics related to endoplasmic reticulum stress, cell cycle dysregulation, neurodegeneration and apoptosis, today announced that it has amended the clinical protocol for its LP-002 Alzheimer's disease bridging diagnostic study of LymPro in order to perform an interim analysis of 44 subjects recruited from a single clinical site, from an originally planned 72 subjects across 4 clinical sites. The Company intends to report full results upon completion of study enrollment from the three additional clinical sites in the 3rd quarter. The Company remains on track to achieve its strategic objectives for LymPro in the 2nd half of 2014.
The interim analysis was performed by Amarantus for the sole purpose of a presentation to be held at the #C4CT Concussion Awareness Summit focused on TBI-induced Alzheimer's disease at the United Nations on July 31st, 2014. The Company elected to perform the interim analysis from subjects at this single site after the LymPro team, headed by Dr. Louis Kirby, a member of the Amarantus Board of Advisors, was advised by our Contract Research Organization overseeing the study that recruitment at three clinical sites was not complete. After discussion with the statisticians and other members of the Company's Board of Advisors, Amarantus management decided the best course of action was to amend the clinical protocol to allow for an interim analysis of data from the subjects recruited from this single site.
"To date, a single site has recruited all subjects and subject data that will constitute the subject population for the interim analysis," said Dr. Kirby. "Data from the interim analysis that will be reported at #C4CT will include N=34 healthy normal and N=10 Alzheimer's disease subjects. We are continuing enrollment at the three clinical sites that recently completed their internal Institutional Review Board (IRB) process and are now enrolling for LP-002. We very much look forward to sharing the interim results tomorrow with the community."
The Lymphocyte Proliferation Test (LymPro Test ®) is a diagnostic blood test that measures the ability of peripheral blood lymphocytes to withstand an external mitogenic stimulation inducing them to enter the cell cycle. It is hypothesized that certain diseases are the result of compromised cellular machinery that leads to abhorrent cell cycle re-entry by neurons. The inventive step for LymPro that makes it a unique asset involves using peripheral blood lymphocytes (PBLs) as a surrogate for neuronal cell function, suggesting a common immune-based relationship between PBLs and neurons in the brain. LymPro Test ® is currently being developed as a diagnostic blood test for Alzheimer's disease and is being evaluated as a diagnostic blood test for Traumatic Brain injury and Chronic Traumatic Encephalopathy.
About Alzheimer's disease
It is estimated that over 5.4 million people in the United States suffer from Alzheimer's disease and over 500,000 patients are diagnosed annually, with nearly one in eight older Americans affected by the disease. Alzheimer's is the third 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 the cost to the United States will exceed $1.4 trillion by 2050.
The Coalition for Concussion Treatment (#C4CT) was founded in 2012 by former NFL player Jack Brewer, CEO of Brewer Sports International, and Gerald Commissiong, President and CEO at Amarantus Bioscience Holdings, Inc., with the goal of bringing together those who are directly affected by TBI-induced neurodegenerative diseases with world class researchers, scientists and industry leaders whom are actively working toward identifying and developing innovative TBI treatment opportunities. #C4CT serves as a platform to spread awareness about concussions and the severe effects of Traumatic Brain Injury (TBI). Through a global campaign uniting people who are passionate about the cause, #C4CT fosters the critical discussions and partnerships needed to enhance research, treatment efforts and prevention. Please visit www.c4ctsummit.com for further details.
About Amarantus BioScience Holdings, Inc.
Amarantus BioScience Holdings (AMBS) is a biotechnology company developing treatments and diagnostics for diseases associated with neurodegeneration and protein misfolding-related apoptosis. AMBS has licensed Eltoprazine ("Eltoprazine"), a phase 2b ready small molecule indicated for Parkinson's Levodopa induced dyskinesia and Adult ADHD. AMBS has an exclusive worldwide license to the Lymphocyte Proliferation test ("LymPro Test(R)") for Alzheimer's disease and 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. AMBS also owns intellectual property for the diagnosis of Parkinson's disease ("NuroPro") and the discovery of neurotrophic factors ("PhenoGuard"). Amarantus operations are located at Janssen Labs @QB3 in San Francisco, CA. For further information please visit www.Amarantus.com, or connect with the Company on Facebook, LinkedIn, Twitter and Google+.
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CONTACT: Amarantus Bioscience Holdings, Inc.: Aimee Boutcher, Investor Relations 408.737.2734 x 101 firstname.lastname@example.org