Todos Medical Announces Positive Alzheimer's Biomarker Clinical Data from LymPro vs. Amyloid PET Interim Analysis
REHOVOT, Israel, July 15, 2019 (GLOBE NEWSWIRE) --
Todos Medical Ltd. (OTCQB: TOMDF), a clinical-stage in-vitro diagnostic company focused on the development of blood tests for the early detection of cancer and neurodegenerative disorders, such as Alzheimer's disease (AD), today announced positive results from a pre-specified interim analysis of 20 subjects from an ongoing 40-subject outpatient study evaluating the relationship between LymPro Test™ (LymPro) scores with amyloid PET imaging scores. LymPro measures cell cycle dysfunction in peripheral lymphocytes. The data revealed strong and statistically significant correlation between LymPro scores and amyloid PET neuroimaging cSUVR scores (r = -0.849; p = 0.00000216).
The study is being conducted under the direction of Dr. Thomas Arendt at the University of Leipzig in Germany, with mild cognitive impairment (MCI) and dementia patients evaluated in the clinic of the Neurobiological Research group in the Department of Psychiatry and Psychotherapy. Todos Medical expects Leipzig to complete patient enrollment in the second half of 2019, and to disclose full results in a future scientific conference. The study is being sponsored by Todos Medical’s joint venture company, Breakthrough Diagnostics, Inc. (Breakthrough). Todos Medical has exercised its option to acquire full ownership of Breakthrough from Amarantus Bioscience Holdings, Inc., and is in the process of completing the acquisition.
Todos is sponsoring the Investacure Cure Coin Awards Reception at 7pm PT today at The Association, 110 East 6th Street, Los Angeles, CA 90014 during the Alzheimer’s Association International Conference (AAIC). Company executives will be available to speak with media and others during the event.
“While the pre-specified interim analysis findings are preliminary, these strong correlative LymPro Test results suggest an underlying association between cell cycle dysfunction (CCD) as measured in lymphocytes with the histological evidence of CCD occurring in the brains of Alzheimer’s patients. This intermediary correlation with amyloid plaque pathology measured ante mortem by amyloid PET neuroimaging is encouraging, considering the documented neuropathological concurrence of CCD and β-amyloid pathology in AD patients. Given that previous research shows LymPro distinguishes healthy older controls from MCI and AD patients, and that this study population represents routine clinical practice, we are very excited by these findings,” said Dr. Paula Trzepacz, incoming Chief Medical Officer for Todos Medical.
“If confirmed at study completion, these results suggest that LymPro will be a useful adjunctive biological diagnostic test that adds confidence to a clinical AD diagnosis. Importantly, LymPro would be a convenient and more cost-effective approach to pre-qualify patients enrolling in Alzheimer’s clinical trials. Such enrichment of the study population screened for trial inclusion could drastically reduce the time and cost of recruiting patients for Alzheimer’s therapeutic studies – a key need for the biopharmaceutical industry,” she added. “We look forward to completing enrollment of the remaining 20 subjects to confirm these encouraging results as we prepare to launch LymPro as an investigational use only (IUO) biomarker assay for patient selection in clinical trials.”
https://investorshangout.com/recentnews/TOMDF#ixzz5tkCGxGP4
REHOVOT, Israel, July 15, 2019 (GLOBE NEWSWIRE) --
Todos Medical Ltd. (OTCQB: TOMDF), a clinical-stage in-vitro diagnostic company focused on the development of blood tests for the early detection of cancer and neurodegenerative disorders, such as Alzheimer's disease (AD), today announced positive results from a pre-specified interim analysis of 20 subjects from an ongoing 40-subject outpatient study evaluating the relationship between LymPro Test™ (LymPro) scores with amyloid PET imaging scores. LymPro measures cell cycle dysfunction in peripheral lymphocytes. The data revealed strong and statistically significant correlation between LymPro scores and amyloid PET neuroimaging cSUVR scores (r = -0.849; p = 0.00000216).
The study is being conducted under the direction of Dr. Thomas Arendt at the University of Leipzig in Germany, with mild cognitive impairment (MCI) and dementia patients evaluated in the clinic of the Neurobiological Research group in the Department of Psychiatry and Psychotherapy. Todos Medical expects Leipzig to complete patient enrollment in the second half of 2019, and to disclose full results in a future scientific conference. The study is being sponsored by Todos Medical’s joint venture company, Breakthrough Diagnostics, Inc. (Breakthrough). Todos Medical has exercised its option to acquire full ownership of Breakthrough from Amarantus Bioscience Holdings, Inc., and is in the process of completing the acquisition.
Todos is sponsoring the Investacure Cure Coin Awards Reception at 7pm PT today at The Association, 110 East 6th Street, Los Angeles, CA 90014 during the Alzheimer’s Association International Conference (AAIC). Company executives will be available to speak with media and others during the event.
“While the pre-specified interim analysis findings are preliminary, these strong correlative LymPro Test results suggest an underlying association between cell cycle dysfunction (CCD) as measured in lymphocytes with the histological evidence of CCD occurring in the brains of Alzheimer’s patients. This intermediary correlation with amyloid plaque pathology measured ante mortem by amyloid PET neuroimaging is encouraging, considering the documented neuropathological concurrence of CCD and β-amyloid pathology in AD patients. Given that previous research shows LymPro distinguishes healthy older controls from MCI and AD patients, and that this study population represents routine clinical practice, we are very excited by these findings,” said Dr. Paula Trzepacz, incoming Chief Medical Officer for Todos Medical.
“If confirmed at study completion, these results suggest that LymPro will be a useful adjunctive biological diagnostic test that adds confidence to a clinical AD diagnosis. Importantly, LymPro would be a convenient and more cost-effective approach to pre-qualify patients enrolling in Alzheimer’s clinical trials. Such enrichment of the study population screened for trial inclusion could drastically reduce the time and cost of recruiting patients for Alzheimer’s therapeutic studies – a key need for the biopharmaceutical industry,” she added. “We look forward to completing enrollment of the remaining 20 subjects to confirm these encouraging results as we prepare to launch LymPro as an investigational use only (IUO) biomarker assay for patient selection in clinical trials.”
https://investorshangout.com/recentnews/TOMDF#ixzz5tkCGxGP4
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