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Amarantus Announces Positive Data From 140 Subject LP-002 Clinical Study of LymPro Test(R) Confirming Statistically Significant Markers for Alzheimer's
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SAN FRANCISCO and GENEVA, Jan. 15, 2015 (GLOBE NEWSWIRE) -- Amarantus BioScience Holdings, Inc. (OTCQB: AMBS), a biotechnology company focused on the development of diagnostics for neurology and therapeutic products in the areas of neurology, psychiatry, ophthalmology and regenerative medicine, reported positive top-line results of its LP-002 study of the Lymphocyte Proliferation Test (LymPro Test®) blood diagnostic for Alzheimer's disease (AD). Results from the 140-subject study demonstrated that multiple individual biomarkers achieved statistically significant results to correctly identify patients with AD from healthy controls. The company recently completed 'Fit-for-Purpose' assay validation for LymPro at Icon Central Laboratories in Farmingdale, NY, enabling the assay to be offered to the pharmaceutical industry for evaluation in therapeutic Alzheimer's clinical trials. Biomarker services using LymPro Test biomarker data are now available to the pharmaceutical industry for Investigational Use Only (IUO) in pharmaceutical therapeutic clinical development programs.
In addition, the company identified a new, undisclosed biomarker that correlates with AD diagnosis in the LP-002 study (p<0.0001). This new marker could become a central component of a multivariate algorithm (LymPro Score) that is currently being analyzed by company scientists to deliver a simplified assessment of an individual's likelihood of having Alzheimer's disease.
"LymPro represents an innovative approach to improving the diagnosis of Alzheimer's disease by measuring a fundamental aspect of disease biology," said Gerald E. Commissiong, President & CEO of Amarantus. "The fact that LymPro has the ability to distinguish patients with early stage AD from control subjects will be important to the pharmaceutical industry engaged in Alzheimer's research. We believe LymPro will have an important impact on future therapeutic drug development programs enabling pharmaceutical companies the opportunity to both enrich clinical trial populations, as well as monitor relevant biology in AD subjects."
In the 140-subject study assessing 71 patients with mild-to-severe AD versus a control group of 69 healthy subjects, the expression of the marker CD69 on specific subpopulations of lymphocytic cells was statistically significantly lower in the AD groups versus the control group, as measured under two different mitogenic stimulation conditions (LymPro Version 1 and LymPro Version 2). The LymPro Version 1 assay replicated previous published work, most notably with the CD19+ positive lymphocytes (p=0.0005), confirming published literature. Each of the three stages of Alzheimer's disease showed significant differences in marker expression as compared to healthy controls.
In addition, after further analysis of a 44 subject 7-year longitudinal retrospective study including a patient record clinical data assessment over time, LymPro was able to distinguish Alzheimer's disease from Parkinson's and vascular dementias with a sensitivity of 94% and specificity of 65% (p=0.0002). This is of importance because it may assist pharmaceutical companies in distinguishing dementia of the Alzheimer's type from dementia of a different etiology.
A copy of a corporate presentation reviewing the data is available online on the company's website at http://ir.amarantus.com/presentations.
As described in the published literature, CD69 is a protein expressed when lymphocytic blood cells are undergoing proliferation, and is considered an early marker of cell division. Low levels of CD69 under cell division conditions in AD patients is indicative of lymphocytic cell cycle dysregulation and a surrogate marker for the neuronal cell cycle dysregulation that has been observed in the brains of AD patients at autopsy.
"Not only is LymPro a consistent and reliable tool in diagnosing Alzheimer's disease, having completed 'Fit-for-Purpose' assay validation at Icon, it may now be used to enrich inclusion criteria in pharmaceutical clinical studies," said Colin Bier, Chief Development Officer of Amarantus Diagnostics, the company's newly created wholly-owned subsidiary. "Use of the LymPro Test will likely mitigate principal investigators' risk of selecting the wrong patients for inclusion in clinical studies of Alzheimer's therapeutics."
Amarantus intends to publish data from these studies in peer-reviewed journals as well as present them at various scientific congresses throughout the course of 2015.
Amarantus Announces Positive Data From 140 Subject LP-002 Clinical Study of LymPro Test(R) Confirming Statistically Significant Markers for Alzheimer's
Download PDF
SAN FRANCISCO and GENEVA, Jan. 15, 2015 (GLOBE NEWSWIRE) -- Amarantus BioScience Holdings, Inc. (OTCQB: AMBS), a biotechnology company focused on the development of diagnostics for neurology and therapeutic products in the areas of neurology, psychiatry, ophthalmology and regenerative medicine, reported positive top-line results of its LP-002 study of the Lymphocyte Proliferation Test (LymPro Test®) blood diagnostic for Alzheimer's disease (AD). Results from the 140-subject study demonstrated that multiple individual biomarkers achieved statistically significant results to correctly identify patients with AD from healthy controls. The company recently completed 'Fit-for-Purpose' assay validation for LymPro at Icon Central Laboratories in Farmingdale, NY, enabling the assay to be offered to the pharmaceutical industry for evaluation in therapeutic Alzheimer's clinical trials. Biomarker services using LymPro Test biomarker data are now available to the pharmaceutical industry for Investigational Use Only (IUO) in pharmaceutical therapeutic clinical development programs.
In addition, the company identified a new, undisclosed biomarker that correlates with AD diagnosis in the LP-002 study (p<0.0001). This new marker could become a central component of a multivariate algorithm (LymPro Score) that is currently being analyzed by company scientists to deliver a simplified assessment of an individual's likelihood of having Alzheimer's disease.
"LymPro represents an innovative approach to improving the diagnosis of Alzheimer's disease by measuring a fundamental aspect of disease biology," said Gerald E. Commissiong, President & CEO of Amarantus. "The fact that LymPro has the ability to distinguish patients with early stage AD from control subjects will be important to the pharmaceutical industry engaged in Alzheimer's research. We believe LymPro will have an important impact on future therapeutic drug development programs enabling pharmaceutical companies the opportunity to both enrich clinical trial populations, as well as monitor relevant biology in AD subjects."
In the 140-subject study assessing 71 patients with mild-to-severe AD versus a control group of 69 healthy subjects, the expression of the marker CD69 on specific subpopulations of lymphocytic cells was statistically significantly lower in the AD groups versus the control group, as measured under two different mitogenic stimulation conditions (LymPro Version 1 and LymPro Version 2). The LymPro Version 1 assay replicated previous published work, most notably with the CD19+ positive lymphocytes (p=0.0005), confirming published literature. Each of the three stages of Alzheimer's disease showed significant differences in marker expression as compared to healthy controls.
In addition, after further analysis of a 44 subject 7-year longitudinal retrospective study including a patient record clinical data assessment over time, LymPro was able to distinguish Alzheimer's disease from Parkinson's and vascular dementias with a sensitivity of 94% and specificity of 65% (p=0.0002). This is of importance because it may assist pharmaceutical companies in distinguishing dementia of the Alzheimer's type from dementia of a different etiology.
A copy of a corporate presentation reviewing the data is available online on the company's website at http://ir.amarantus.com/presentations.
As described in the published literature, CD69 is a protein expressed when lymphocytic blood cells are undergoing proliferation, and is considered an early marker of cell division. Low levels of CD69 under cell division conditions in AD patients is indicative of lymphocytic cell cycle dysregulation and a surrogate marker for the neuronal cell cycle dysregulation that has been observed in the brains of AD patients at autopsy.
"Not only is LymPro a consistent and reliable tool in diagnosing Alzheimer's disease, having completed 'Fit-for-Purpose' assay validation at Icon, it may now be used to enrich inclusion criteria in pharmaceutical clinical studies," said Colin Bier, Chief Development Officer of Amarantus Diagnostics, the company's newly created wholly-owned subsidiary. "Use of the LymPro Test will likely mitigate principal investigators' risk of selecting the wrong patients for inclusion in clinical studies of Alzheimer's therapeutics."
Amarantus intends to publish data from these studies in peer-reviewed journals as well as present them at various scientific congresses throughout the course of 2015.
