TORONTO, ON (June 8, 2017) − 3D Signatures Inc. (TSXV:DXD; OTCQB:TDSGF; FSE:3D0) (the “Company” or “3DS”), is pleased to announce that the clinical trial component (the “Clinical Trial”) of its Hodgkin’s lymphoma (“HL”) test (“Telo-HL”) validation program is successfully underway. This process is referred to as Stage 3 of the validation program as set out in the Company’s news release dated February 23, 2017. Assay development and assay validation, Stage 1 and Stage 2 of the validation program, respectively, were completed on schedule. The Clinical Trial is expected to be complete by Sept 30, 2017.
Powered by the Company’s proprietary TeloView™ software platform, Telo-HL stratifies HL patients at the point of diagnosis into non-relapsing and relapsing patients. Relapsing patients may then be considered for alternative treatments at the time of diagnosis rather than waiting until they have failed multiple rounds of standard chemotherapy. There is currently no biomarker available that can predict patient response to standard chemotherapy in HL patients.
The Clinical Trial involves the analysis of 400-480 retrospective HL patient samples that match the targeted prognostic criteria for Telo-HL. The sample size is expected to provide robust data on which expert statisticians will assess six different TeloViewTM parameters relative to clinical outcome data and develop and finalize a statistical scoring model to predict patient risk profiles. The scoring model will set both high positive and high negative predictive value cut-offs, establishing Telo-HL’s accuracy to indicate a patient’s risk of relapse within 1 year.
The Company expects Telo-HL to benefit patients seeking personalized treatment while also providing significant cost savings to payors and insurers that are currently burdened with expensive treatments and procedures that may not be necessary if patients could be considered for more targeted and effective therapies at the outset.
“We are now that much closer to an effective biomarker for Hodgkin’s lymphoma,” said Jason Flowerday, CEO of 3D Signatures. “I am particularly proud of our laboratory team. They hit the ground running at our new facility in Toronto just a few weeks ago. Their dedication to the validation program has been exceptional.”
3DS (TSXV:DXD; OTCQB:TDSGF; FSE:3D0) is a personalized medicine company with a proprietary software platform based on the three-dimensional analysis of chromosomal signatures. The technology is well developed and supported by 22 clinical studies on over 2,000 patients on 13 different cancers and Alzheimer’s disease. Depending on the desired application, this platform technology can measure the stage of disease, rate of progression of disease, drug efficacy, and drug toxicity. The technology is designed to predict the course of disease and to personalize treatment for the individual patient. For more information, visit the Company’s website at http://www.3dsignatures.com.
This news release includes forward-looking statements that are subject to risks and uncertainties. Forward-looking statements involve known and unknown risks, uncertainties, and other factors that could cause the actual results of the Company to be materially different from the historical results or from any future results expressed or implied by such forward-looking statements. All statements within, other than statements of historical fact, are to be considered forward looking. Although 3DS believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results or developments may differ materially from those in forward-looking statements. Risk factors that could cause actual results or outcomes to differ materially from the results expressed or implied by forward-looking information include, among other things: market demand; technological changes that could impact the Company’s existing products or the Company’s ability to develop and commercialize future products; competition; existing governmental legislation and regulations and changes in, or the failure to comply with, governmental legislation and regulations; the ability to manage operating expenses, which may adversely affect the Company’s financial condition; the Company’s ability to successfully maintain and enforce its intellectual property rights and defend third-party claims of infringement of their intellectual property rights; adverse results or unexpected delays in clinical trials; changes in laws, general economic and business conditions; and changes in the regulatory regime. There can be no assurances that such statements will prove accurate and, therefore, readers are advised to rely on their own evaluation of such uncertainties. We do not assume any obligation to update any forward-looking statements.
Neither the TSX Venture Exchange nor its Regulation Service Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
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VP Corporate Finance