TORONTO, February 20, 2018
3D Signatures Inc. (TSX-V:DXD) (OTCQB:TDSGF) (FSE:3D0) (the “Company” or “3DS“) is pleased to announce that a preliminary third-party analysis of the trial data for Telo-HLTM, 3DS’ test in development for Hodgkin’s lymphoma (HL), shows that the Company’s TeloViewTM platform is able to distinguish, with a high degree of statistical significance, multiple differences between a patient group that responds to standard ABVD chemotherapy, and a group that relapses or is refractory to treatment within the first 12 months.
Telo-HLTM is intended to provide clinicians with the first biomarker to identify the 15% – 20% of new HL patients who will likely fail standard chemotherapy, and who should immediately be considered for more advanced treatment or inclusion into clinical trials to access emerging treatments such as immunotherapies.
3DS has established a clinically-compliant methodology for application of its TeloViewTM process to diagnostic Hodgkin lymphoma biopsy samples, employing more sensitive imaging technology than its previous HL trials. Specimens from over 400 HL patients (who were subsequently treated with ABVD) were processed for this trial, from four contributing hospital sites across Canada and Europe. The 3DS three-step process was applied, comprising a wet lab co-immuno-telomeres FISH assay, 3-dimensional imaging (with identification of 30 Hodgkin and 30 Reed-Sternberg cells), followed by TeloView™ software analysis.
The multi-parametric telomeric analysis with TeloViewTM was performed by 3DS (blinded to patient status), and the results were then shared with statistical partner BioStat Solutions Inc. (“BSSI”), who compared the TeloViewTM data with the corresponding clinical outcomes for patients, and identified highly significant group differences across multiple TeloViewTM parameters.
“BSSI is excited to be collaborating with 3DS, helping them ensure the quality of the data being used is to the highest standards, and that they are poised to deliver the best possible analysis of this predictive technology for HL treatment,” said Ronald L. Bromley, CEO of BioStat Solutions, Inc.
“We believe that these results from the application of our TeloViewTM platform to Hodgkin’s lymphoma are so strong, the Company will now even more confidently proceed with developing the final scoring model for its Telo-HLTM test to predict response at the individual patient level,” said Jason Flowerday, CEO of 3D Signatures. “This is great news for the Telo-HLTM program, and we remain on track to complete all phases of the test development and analytical validation by April 2018.”
The Company intends to submit the completed test development and validation work to a highly reputable clinical journal for publication in the latter half of 2018.
“This trial builds on the foundational work done in Dr. Sabine Mai’s academic laboratory to establish 3D telomere profiling as a novel biomarker platform. We see this as a new genomic stability testing paradigm applicable broadly across clinical trial research and laboratory medicine”, says Dr. Kevin Little, CSO of 3D Signatures.
Powered by 3DS’ proprietary TeloView™ software platform, Telo-HL™ is intended to provide clinicians with the first set of biomarkers that will distinguish between patients that will respond to standard ABVD chemotherapy, and the 15% – 20% of patients who will fail standard chemotherapy and be refractory or relapse within the first year. The Company expects Telo-HL™ to benefit patients seeking personalized treatment and to provide 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 of treatment.
BioStat Solutions, Inc. (BSSI) is a privately held professional service corporation providing statistical and bioinformatics expertise to pharmaceutical and biotech companies as well as to the government and its contractors. BSSI’s diverse team of statisticians, bioinformaticists, epidemiologists and geneticists provides answers to complex and challenging analytical questions. Whether the client is facing big data or machine learning problems, or is looking for new biomarker or diagnostic device strategies, BSSI provides solid results towards effective decision-making. For more information, visit BSSI’s website at: http://www.biostatsolutions.com.
3DS (TSX-V:DXD; OTCQB:TDSGF; FSE:3D0) 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 imaging 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 TeloView ScoreTM. 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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Cautionary Note Regarding Forward-Looking Statements
This news release contains forward looking statements which constitute “forward looking information” within the meaning of applicable Canadian securities legislation (“Forward-Looking Statements”). All statements included herein, other than statements of historical fact, are Forward Looking Statements and are subject to a variety of known and unknown risks and uncertainties which could cause actual events or results to differ materially from those reflected in the Forward Looking Statements. Often, but not always, these Forward-Looking Statements can be identified by the use of words such as “estimates”, “potential”, “open”, “future”, “assumes”, “projects”, “anticipates”, “believes”, “may”, “continues”, “expects”, “plans”, “will”, “to be”, or statements that events “could” or “should” occur or be achieved, and similar expressions, including negative variations.
Such Forward Looking Statements reflect the Company’s current views with respect to future events, are subject to risks and uncertainties and are necessarily based upon a number of estimates and assumptions that, while considered reasonable by 3DS as of the date of such statements, are inherently subject to significant medical, scientific, business, economic, competitive, political and social uncertainties and contingencies. Many risk factors could cause the Company’s actual results, performance, achievements, prospects or opportunities to be materially different from any future results, performance or achievements that may be expressed or implied by such Forward Looking Statements, including risks related to 3DS’ management’s discretion over the actual application of the net proceeds and ability to allocate proceeds differently from what is described herein; the risk that the Telo-HLTM test may not be commercially launched as an LDT by the first quarter of 2018, or at all; uncertainties related to 3DS’ clinical trials and test development; risks related to the volatility of the price of 3DS’ common shares; risks related to the possibility that 3DS’ shareholders may experience dilution; risks related to 3DS’ requirements for additional financing and future access to capital, including the risk that the proceeds raised under the Private Placement may be insufficient to finance 3DS’ business objectives; the risk that a positive return on an investment in 3DS’ common shares is not guaranteed; risks related to 3DS’ intention to retain earnings and not pay cash dividends on its common shares in the foreseeable future; risks related to 3DS’ early stage of development; the risk that 3DS’ tests will not be successfully deployed; risks related to 3DS’ dependence on third parties, including collaborative partners, licensors and others; risks related to 3DS’ clinical trial recruitment; that there is currently no market for 3DS’ products and that such market may be slow to develop if at all; risks related to 3DS’ reliance on key personnel; risks related to the competitive nature of the biotechnology industry; risks related to 3DS’ limited operating history, lack of revenue, history of losses and inability to assure that it will earn profits in the future or that profitability will be sustained; risks related to government regulation; risks related to rapid technological change; risks related to the fact that 3DS’ software may now or in the future contain undetected errors, bugs or vulnerabilities; the risk that 3DS or its directors and officers may be subject to a variety of civil or other legal proceedings, with or without merit, including product liability claims; risks related to the protection of 3DS’ intellectual property rights; risks related to 3DS’ limited sales, marketing and distribution experience; risks related to the possibility that 3DS’ directors and officers may be placed in a conflict of interest as a result of their employment or affiliation with third parties, risks related to 3DS’ use and storage of personal information and compliance with applicable privacy laws, as well as those risks discussed under the heading “Risk Factors” in the Company’s management’s discussion and analysis dated November 29, 2017 and filed on SEDAR. Although the Company has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in the Forward-Looking Statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended.
In making the Forward-Looking Statements, the Company has made various material assumptions including, but not limited to, obtaining positive results from 3DS’ current and planned clinical trials and research and development initiatives; that the Telo-HLTM test will be commercially launched as an LDT by the first quarter of 2018; obtaining regulatory approvals with respect to 3DS’ clinical trials which are now ongoing or may in the future be commenced; 3DS’ ability to successfully develop its tests; assumptions regarding general business and economic conditions; that 3DS’ current positive relationship with third parties will be maintained; the availability of future financing on reasonable terms; 3DS’ ability to attract and retain skilled staff; assumptions regarding market competition and the products and technology offered by 3DS’ competitors; and 3DS’ ability to protect patents and proprietary rights.
3DS believes that the assumptions and expectations reflected in the Forward-Looking Statements in this press release are reasonable, but no assurance can be given that these expectations will prove to be correct. Forward Looking Statements should not be unduly relied upon. This information speaks only as of the date of this press release, and 3DS will not necessarily update this information, unless required to do so by securities laws.
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