Toronto, December 04, 2018 – 3D Signatures Inc. (TSX-V:DXD) (the “Company” or “3DS“) announces that the Board of Directors and executive management, in consultation with key opinion leaders and strategic partners, are evaluating the status of all clinical programs in the Company’s pipeline to define priority initiatives for immediate pursuit.
Historically, the Company has pursued a number of clinical programs including Hodgkin’s lymphoma (“HL”), prostate cancer (“PC”) and lung cancer (“LC”). The Company also planned several additional clinical studies for Alzheimer’s Disease (“AD”), multiple myeloma (“MM”), and a second prostate cancer study. The current status of these programs is as follows:
The Company’s most advanced program is the Telo-HLTM test for stratifying newly diagnosed Hodgkin’s lymphoma patients who receive standard chemotherapy into responders versus non-responders. To date the Company secured biological samples for over 500 HL cases from four different sites, and the clinical data associated with the biological samples from three of the four sites. TeloViewTM analysis was completed on approximately 330 cases. The preliminary statistical analysis conducted on 150-200 cases indicates a high potential for development of a successful scoring model. The estimated cost to complete this study is $80,000 with a duration of 4-6 months from commencement.
Since November 2016, the Company has been involved in a multi-centre prostate cancer clinical trial titled “PRECISE” (PRostate Evaluation for Clinically Important disease MRI vs Standard Evaluation procedures). 3DS’ participation in PRECISE sought to provide essential data for developing several non-invasive blood-based clinical tests for personalized assessment of prostate cancer patients. This study is ongoing with biological samples collected for TeloViewTM analysis being currently received and processed at Dr. Mai’s academic laboratory at the University of Manitoba, in collaboration with ScreenCell (Paris, France), the Canadian Urology Research Consortium (CURC), led by Dr. Laurence Klotz, Professor, University of Toronto, and 3DS.
The Company has pursued two pilot studies related to lung cancer in partnership with the Institut Universitaire de Cardiologie et de Pneumologie De Quebec (“IUCPQ”). The first study included 20 patients and sought to explore the utility of TeloViewTM analysis to distinguish between 2 forms of LC, multiple synchronous lung adenocarcinoma (“AC”) and metastatic lung AC. The results of the study were presented at the 17th World Conference on Lung Cancer in December 2016. The Company recently conducted a second LC pilot study with 40 patients in collaboration with IUCPQ to benchmark tumour mutational burden against TeloViewTM analysis in measuring genomic instability. The Company has also planned a third lung cancer retrospective pilot study to evaluate TeloViewTM utility to identify lung cancer patients who responded to recently FDA approved immunotherapies. The estimated cost to complete all of the LC pilot studies is $120,000 with a duration of 3-4 months from commencement.
The Company has planned two retrospective pilot studies for MM. The first study is designed to evaluate the efficacy of the TeloViewTM platform to stratify smouldering (high-risk) MM patients, who progressed into full MM within 2 years, versus stable patients who did not progress to full MM within 5 years. The second pilot study plans to examine whether TeloViewTM analysis will predict MM patient who responded to common combinatory chemotherapy treatment. Each pilot study is expected to include 40-50 patients. The estimated cost to complete both of the MM pilot studies is $120,000 with a duration of 2-3 months from commencement.
3DS (TSX-V:DXD) is a personalized medicine company with a proprietary software platform, TeloViewTM, that is designed to predict the course of certain diseases and to tailor treatment options for the individual patient. The technology is based on the three-dimensional analysis of telomeres, the protective caps at the ends of chromosomes. 3DS’ TeloViewTM software platform measures the organization of the genome and its correspondence to; the stage of a given disease, the rate of progression of the disease, how different diseases will respond to various therapies, and a drug’s efficacy and toxicity. 3DS’ proprietary software is designed to go beyond identifying whether a patient suffers from a specific disease or condition. Instead, the TeloViewTM platform is designed to inform clinicians and patients with respect to how to personalize treatment and best manage an individual’s disease based on their unique TeloViewTM score. As healthcare moves increasingly toward better informed, patient-centric approaches, the Company intends for the TeloViewTM platform to deliver personalized medicine that allows for better treatments, leading to better outcomes. The TeloViewTM platform is supported by 25 clinical studies involving more than 3,000 patients and 20 different cancers, plus Alzheimer’s disease. 3DS benefits from twenty years of research, $25M of non-dilutive investment into its platform and more than 130 supporting publications and holds a portfolio of patents related to three-dimensional telomere analysis for proliferative diseases, including (but not limited to) hematological disorders such as Hodgkin’s lymphoma, multiple myeloma, and chronic myeloid leukemia. 3DS’ intellectual property portfolio also covers prostate cancer, breast cancer, lung cancer, melanoma, colorectal cancer, and Alzheimer disease.
For more information, visit the Company’s website at: http://www.3dsignatures.com.
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www.3dsignatures.com TSX.V: DXD
MaRS Centre, South Tower, 101 College Street, Suite 200, Toronto ON, M5G 1L7
TSX Venture Exchange Disclaimer
Neither the TSX Venture Exchange nor its Regulation Services Provider (as such term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release. Cautionary Note Regarding Forward-Looking Statements Certain information contained herein may constitute “forward-looking information” under Canadian securities legislation. Generally, forward-looking information can be identified by the use of forward-looking terminology such as “intends”, “will”, or variations of such words and phrases or statements that certain actions, events or results “will” occur. Forward-looking statements regarding access to funding, collaboration and commercial opportunities, the Company’s assessment of current and future clinical programs, and efficacy and success of the TeloViewTM platform are based on the Company’s estimates and are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance or achievements of the Company to be materially different from those expressed or implied by such forward-looking statements or forward-looking information, including capital expenditures and other costs. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements and forward-looking information. The Company will not update any forward-looking statements or forward-looking information that are incorporated by reference herein, except as required by applicable securities laws.