Tailwinds’ Take: while not a huge milestone, this is another step forward towards full FDA product approval. 3DS is proving, with every positive result, that they are developing the most effective diagnostic tools in the industry.
WINNIPEG, Manitoba, March 29, 2017 (GLOBE NEWSWIRE) — 3D Signatures Inc. (TSXV:DXD) (OTCQB:TDSGF) (FSE:3D0) (the “Company” or “3DS”), is pleased to announce that it has successfully completed internal analytical assay validation for its Hodgkin’s lymphoma (“HL”) test (“Telo-HL”) pursuant to FDA guidelines. Assay validation of Telo-HL included validating the consistency of key reagents and the reproducibility and repeatability of the locked protocol. This process is referred to as Stage 2 of the validation program as set out in the Company’s news release dated February 23, 2017. Assay validation was completed on schedule.
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 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.
“The data collected during this validation stage confirms that the Telo-HL assay is reproducible according to FDA guidelines for clinical quantitative assays,” stated Dr. Oumar Samassekou, 3DS’ VP of Clinical Technology. “We are ready and excited to launch the clinical trial to develop and finalize the scoring model for Telo-HL. This will establish a score to delineate relapsing from non-relapsing patients at the time of diagnosis, before they begin first-line chemotherapy.”
The clinical trial will commence in the coming weeks and include the analysis of 250-300 retrospective HL patient samples that match the targeted prognostic criteria for the test. A statistical scoring model will also be developed and finalized from the data collected during the clinical trial. The clinical trial is expected to be complete in less than five months.
3DS (TSX-V: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 new 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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