Todos Medical and Orot+ Announce First Patient Enrolled in Pre-Commercial Launch Preparations of TM-B1 and TM-B2 Breast Cancer Blood Screening Tests in Europe
REHOVOT, Israel, Sept. 24, 2019 (GLOBE NEWSWIRE) -- Todos Medical Ltd. (OTCQB: TOMDF), a clinical-stage in-vitro diagnostics company focused on the development of blood tests for the early detection of cancer and neurodegenerative disorders, and Orot+, the operational division of Orot-Luces (http://orot-luces.com), that executed a distribution agreement with Todos for the commercial distribution of Todos’ TM-B1and TM-B2 blood screening tests for breast cancer, today announced the enrollment of the first patient in the pre-commercial launch study of TM-B1 and TM-B2 in Europe. The pre-commercial launch study is expected to last approximately 6 months. Upon completion of the pre-commercial launch study, TM-B1 and TM-B2 are expected to be available for commercial sale in Romania by Orot. Orot is providing full funding for the pre-commercial launch study as well as the commercial launch in accordance with the terms of the exclusive distribution agreement.
“In accordance with the exclusive distribution agreement for both our TM-B1 and TM-B2 breast cancer screens in Romania and Austria executed in April 2019, Orot has commenced screening of patients as part of the agreed upon pre-sale preparation study required to support commercial launch in Romania. We are excited to achieve this critical milestone along our path to full commercialization in Europe,” said Dr. Herman Weiss, President & CEO of Todos Medical. “Our blood tests are designed to screen for the presence of breast cancer at early stages of disease, and we know that early diagnosis and treatment greatly improves patient outcomes.”
“The initiation of the pre-commercial study of Todos Medical’s TM-B1 and TM-B2 breast cancer blood screening tests will help create awareness among the medical community and local patient population of an affordable test that addresses the unmet need for improved breast cancer screening,” said Mr. Ron Streichman, CEO of Orot-Luces. “We have received encouraging feedback from medical practitioners and expect this to continue as they become aware of the significant potential for improved patients outcomes based upon the data generated in this patient population.”
About TM-B1 and TM-B2 Breast Cancer Blood Tests
The Company’s two breast cancer screening tests, TM-B1 and TM-B2, have received CE mark to support commercialization in Europe. In April 2019, the Company entered into an exclusive distribution agreement with Orot+, the operational division of Orot-Luces (http://orot-luces.com), to support the commercial distribution and marketing of TM-B1 and TM-B2 in Romania and Austria. In August 2019, Orot and Todos entered into a memorandum of understanding to expand the territories under the distribution agreement to include Japan.
The TM-B1 assay is indicated for women aged 25 years and older without a diagnosis of inflammatory disease. The assay is intended to be used as a diagnostic method to indicate whether or not a breast malignancy is present. TM-B1 results are initially intended to be used in conjunction with other common diagnostic tests as part of breast cancer screening. In our latest clinical trial, the TM-B1 assay showed a sensitivity of 86% and a specificity of 98%. Positive predictive value was 95.1% and negative predictive value was 93.5%.
The TM-B2 assay is indicated for women who meet the following criteria: Female subjects, aged 25 years and older, without a diagnosis of inflammatory or autoimmune disease and who were diagnosed as presenting with BI-RADS score of 3 or 4 (or equivalent). TM-B2 is to be used to further assess if a malignancy is present or not. TM-B2 results are initially intended to be used in conjunction with other common diagnostic tests as part of breast cancer screening. In our latest clinical trial, the TM-B2 assay showed a sensitivity of 83% and a specificity of 99%.
About Todos Medical Ltd.
Todos Medical Ltd. is an in-vitro diagnostic company engaged in the development of blood tests for the early detection of a variety of cancers, and also has initiated the development of blood tests for neurodegenerative disorders such as Alzheimer's disease through Breakthrough Diagnostics, Inc., its joint venture with Amarantus Bioscience Holdings, Inc. Todos 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 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, have received the CE mark. Breakthrough Diagnostics is developing the LymPro Test®, a blood test for diagnosing Alzheimer’s disease.
For more information, the content of which is not part of this press release, please visit http://www.Todosmedical.com.
About Breakthrough Diagnostics, Inc.
Breakthrough Diagnostics, Inc. is a joint venture owned by Amarantus Bioscience Holdings, Inc. (OTCPK: AMBS) (80.01%) and Todos Medical Ltd. (19.99%). Breakthrough has been assigned the intellectual property and other rights to the LymPro Test®, a diagnostic blood test for Alzheimer’s disease, as well as rights to other neurological diagnostics testing intellectual property. Todos Medical has provided Amarantus with notice of Todos’ decision to exercise its exclusive option to acquire the 80.01% of Breakthrough Diagnostics that it currently does not own.
The Lymphocyte Proliferation Test (LymPro Test™) determines the ability of peripheral blood lymphocytes (PBLs) and monocytes to withstand an exogenous mitogenic stimulation that induces them to enter the cell cycle. It is believed that certain diseases, most notably Alzheimer's disease, are the result of compromised cellular machinery that leads to aberrant cell cycle re-entry by neurons, which then leads to apoptosis. LymPro is unique in the use of peripheral blood lymphocytes as surrogates for neuronal cell function, suggesting a common relationship between PBLs and neurons in the brain.
Orot+, an Israeli company headquartered in Tel-Aviv , is the operational division of Orot-Luces (http://orot-luces.com). Orot+ focuses on connecting innovative solutions with significant unmet needs in the cancer care eco-system mainly in Europe and SE Asia. The Orot+ team has vast experience and a proven track record in building and operating medical services. Orot+ maintains close working relationships with Amethyst (Amethyst-radiotherapy.com) a pan-European Radiotherapy network which the Orot+ team was actively involved in establishing and operating. Orot+ is well established and connected to key opinion leaders, doctors, clinics, hospitals, medical centers and has close working relationships with regulatory bodies and reimbursement agencies.
Certain statements contained in this press release may constitute forward-looking statements. For example, forward-looking statements are used when discussing our expected clinical development programs and clinical trials. These forward-looking statements are based only on current expectations of management, and are subject to significant risks 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 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 to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Todos Medical does not undertake any 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, please refer to its reports filed from time to time with the U.S. Securities and Exchange Commission.
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