Amarantus Announces Positive Clinical Performance and 7-Year Longitudinal Data Poster Presentations for LymPro Test (R) at AAIC 2014
Quote:SAN FRANCISCO and GENEVA, July 15, 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 positive clinical performance data for Version 2 of the Company's proprietary cell cycle dysregulation diagnostic blood assay LymPro Test®, currently under development for Alzheimer's disease diagnosis. The LymPro Test clinical data package assessed was produced in 2008 at Provista Life Sciences. The 7-year longitudinal patient record clinical progression assessment data was conducted by Dr. Marwan Sabbagh at the Banner Sun Health Research institute who originally enrolled the 44 patients involved in the Provista clinical trial, and analyzed by Dr. Louis Kirby, the Company's Chief Medical Officer. LymPro differentially diagnosed Alzheimer's disease versus age-matched other dementias and cognitively intact controls in statistically significant manner. The poster presentations are available online at http://ir.stockpr.com/amarantus/scientific-publications.
The 2014 assessment of LymPro Test improved over time vs. the original 2008 diagnosis in a statistically significant manner across all univariate and multivariate models evaluated based upon the updated longitudinally assessed diagnosis. Further, the overall accuracy of LymPro Version 2 improved vs. LymPro Version 1 across all univariate and multivariate models evaluated based on the 2012 peer-reviewed publication of Stieler et al in Neurobiology of Aging.
"We are extremely pleased to have identified a lead candidate optimization condition for LymPro that demonstrates superiority over the already established Version 1 LymPro assay," said Dr. Louis Kirby, Chief Medical Officer to Amarantus. "New non-invasive diagnostic tools for Alzheimer's disease have emerged as a key deficiency in the field. While the data presented today is based upon a non-analytically-validated assay, the assessment of an underlying disease biology of cell cycle dysregulation seems to have overpowered these deficiencies. Longitudinal assessments of clinical diagnoses are critical for in-life Alzheimer's disease diagnosis, given that only autopsy definitively confirms the diagnosis, therefore making these data sets meaningful in spite of the small sample size. We look forward to completing the currently-enrolling Bridging Study that will vastly expand the Version 2 data package, and sharing top-line results in two weeks at #C4CT."
The Company is currently conducting a Version 1 vs. Version 2 Bridging Study (previously known as the Pilot Study) at BD Biosciences comparing Alzheimer's patients to cognitively intact, aged-matched controls to assess LymPro's accuracy in a head to head comparison across various univariate measurements and multivariate models. The study will provide the basis for the establishment of initial sensitivity and specificity in Version 1 and Version 2 of LymPro in the newly-analytically controlled LymPro conditions established at BD Biosciences. The Company expects to release topline Bridging Study data at the #C4CT Concussion Awareness Summit: TBI-induced Alzheimer's Disease to be held at the United Nations on July 31st.
"We are pleased that the LymPro program is maturing at its current pace," said Gerald E. Commissiong, President & CEO of Amarantus. "We believe that we are accurately able to measure a fundamental Alzheimer's disease biology with LymPro, and therefore may be able to improve the current diagnostic paradigm in Alzheimer's disease. Abnormal cell cycle re-entry is continuing to gain traction as a key component of the overall disease biology of Alzheimer's disease, linking directly to amyloid plaque depositions and toxic tau hyperphosphorylation. Given that we are measuring disease biology, we are focused on the assay validation required to commercialize LymPro, and thereafter continue further development in a commercial environment. We look forward to developing larger and more robust data sets in that they will further enhance LymPro's predictive value in a commercial environment so that robust data findings may be immediately translated into clinical practice for pharmaceutical companies and key opinion physicians conducting research. We are pleased these initial clinical performance and longitudinal assessments conducted by Amarantus corroborate the published findings and provide the basis for Amarantus to further invest in LymPro's development, and look forward to sharing additional data in two weeks at #C4CT."
