REHOVOT, Israel—Todos Medical Ltd. has 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 scores and amyloid PET imaging scores, as regards the detection of Alzheimer’s disease (AD).
The LymPro test 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 being 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 sponsored by Todos Medical’s joint venture company Breakthrough Diagnostics, Inc. 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.
“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,” said Dr. Paula Trzepacz, incoming chief medical officer for Todos Medical.
“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,” she added. “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. “
According to Trzepacz, “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. 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 biomarker assay for patient selection in clinical trials.”
In August, Todos Medical also announced the appointment of Dr. Jorge Leon as a medical advisor to assist the company in clinical development, regulatory strategy and fund raising. Leon is an in-vitro diagnostics expert, having served as a key executive in the establishment of what is now known as Quest Diagnostics.
“The importance of early disease detection cannot be overstated, and the earliest signs of disease often appear when looking at the immune system. Todos’ cancer and Alzheimer’s platforms have been developed with the specific intention of being able to measure fundamental disease pathology in the immune system at the earliest stages,” said Leon in a press release.
“I am excited to work closely with the team being assembled to help drive clinical and regulatory execution so that these early disease screening platforms can reach their full commercial potential, with an initial focus on early adoption along key constituencies in the US and abroad,” he added. “The early detection of cancer would dramatically improve patient outcomes, and the early detection of Alzheimer’s disease is the key unmet need to drive research investment towards altering the underlying course of disease progression before it becomes too late to intervene.”
Leon is internationally recognized for his pioneering work in molecular diagnostics. He holds a Ph.D. in cellular and molecular biology from New York University, and completed his postdoctoral studies at the German Cancer Research Center in Heidelberg and Columbia University in NYC. Leon’s subsequent academic research at Columbia University focused on developing monoclonal antibody-based tumor marker assays and radio-immuno imaging devices, which are currently in wide use.
“Dr. Leon’s track record speaks for itself in terms of his accomplishments and contributions to the field of human diagnostics by dramatically improving patient access to cutting-edge diagnostics technologies,” noted Dr. Herman Weiss, president and CEO of Todos Medical. “We are excited to bring Dr. Leon onto the team at Todos as we are preparing to launch our TBIA cancer platform in Europe and Israel, as well as assisting biopharmaceutical companies in their quest to develop new therapeutics for Alzheimer’s. His expertise and relationships will be instrumental to Todos’ progress as we move forward.”