Todos Medical initiates clinical trial of its blood test for breast cancer in Kaplan Hospital, Rehovot, Israel for subjects undergoing breast cancer screening

Rehovot, ISRAEL

REHOVOT, Israel, March 05, 2018 (GLOBE NEWSWIRE) -- Todos Medical Ltd. (OTC Pink:TOMDF) ( today announced the initiation of its first blinded clinical trial for TM-B1 – a simple blood test for breast cancer screening. The study will be conducted in Kaplan Hospital located in Rehovot, Israel and include about 200 patients (NIH identifier: NCT03343691).

“We are very excited to continue the development of our cancer detection technology, Total Biochemical Infrared Analysis (TBIA), for this high-need indication. We have been encouraged by our previous successful breast cancer screening trials to date and we look forward to the commencement of this study,” commented Todos Medical CEO Rami Zigdon.

TM-B1 test is based on TBIA technology for biochemical analysis of blood components - plasma and peripheral blood mononuclear cells (PBMCs) using infrared (FTIR) spectroscopy. The TM-B1 assay is indicated for biochemical measurements of blood, as an aid in the identification of abnormality in plasma and PBMCs biochemistry, which may indicate tumor presence. While most of the biomarkers assays lean on a single or multiple markers which are directly related to the tumor, TM-B1 ‘observes’ the biochemical composition (e.g. proteins, lipids, nucleic-acids, carbohydrates) of the PBMCs and the plasma and learns patterns in the ‘biochemical picture’ which are characteristics of cancer patients. 

PBMCs, as well as plasma, are known to be affected by the presence of a tumor at all stages. T cells (and specifically regulatory T cells) as well as B cells, natural killers and platelets, are all participating in identifying or protecting tumor cells at different stages of its development. TM-B1 assay ‘observes’ characteristic biochemical changes in these blood cells and compose a ‘picture’ of cancer patients’ population vs benign and healthy. Plasma, together with PBMCs from the same blood sample, gives additional important relevant information about tumor presence.

Prior clinical studies1 have shown that TBIA was able to detect breast cancer with a sensitivity and specificity of  93% and 87% respectively.  We believe the results of our clinical trials conducted to date demonstrate the capability to simply and rapidly detect malignant breast and colon tumors in comparison to a controlled healthy group. We expect that future broad clinical trial studies should reveal the full potential of our technology in the early identification of cancer.  Our proprietary innovation is conducive to constant improvement in our proprietary algorithm as we ascend the learning curve, thereby improving our test performances with each test.

1. Zelig, Udi, et al. "Early detection of breast cancer using total biochemical analysis of peripheral blood components: a preliminary study." BMC cancer 15.1 (2015): 408.

About Todos Medical

Todos Medical Ltd. (OTC Pink:TOMDF) an Israeli company headquartered in Rehovot, is a cancer in-vitro-diagnostic (“IVD”) company engaging in the development of a series of blood tests for the early detection of a variety of cancers. The company has developed two cancer screening tests based on TBIA (Todos Biochemical Infrared Analyses), a method for cancer screening using peripheral blood analysis. The TBIA screening method is based on the cancer’s influence on the immune system which triggers biochemical changes in peripheral blood mononuclear cells (“PBMC”) and plasma. This proprietary and patented method incorporates biochemistry, physics and signal processing. The company’s two cancer screening tests, TM-B1 and TM-B2 are CE marked in the EU.

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Forward-looking statements: This press release contains forward-looking statements. For example, we are using forward-looking statements when we discuss our expected clinical development programs and clinical trials. These forward-looking statements are only based on the current expectations of the management of Todos Medical, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements, including the risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval or patent protection for our product candidates; competition from other biotechnology companies; and our ability to obtain additional funding required to conduct our research, development and commercialization activities. In addition, the following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; delays or obstacles in launching our clinical trials; changes in legislation; inability to timely develop and introduce new technologies, products and applications; lack of validation of our technology as we progress further and lack of acceptance of our methods by the scientific community; inability to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties that may develop with our process; greater cost of final product than anticipated; loss of market share and pressure on pricing resulting from competition; and laboratory results that do not translate to equally good results in real settings, all of which could cause the actual results or performance of Todos Medical to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Todos Medical undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Todos Medical, reference is made to Todos Medical’s reports filed from time to time with the U.S. Securities and Exchange Commission.

Media Contact:

Todos Medical Ltd.
Daniel Hirsch
Investor Relations
(347) 699-0029