3D Signatures Inc. (TSXV:DXD) (OTCQB:TDSGF) (FSE:3D0) (the “Company” or “3DS”), is pleased to announce that, on September 30, 2017, the Company completed the clinical trial component (the “Clinical Trial”), or Stage 3, of its Hodgkin’s lymphoma (“HL”) test (“Telo-HLTM”) validation program. Data from the Clinical Trial has been submitted to the Company’s statistics consulting partner for analysis.
“We are excited to accomplish this critical milestone on schedule, and we remain on track for the expected commercial launch of Telo-HLTM as an LDT by the end of Q1 2018,” commented Jason Flowerday, CEO of 3DS.
Powered by the Company’s proprietary TeloViewTM software platform, Telo-HLTM is designed to stratify HL patients at the point of diagnosis into patients with aggressive or non-aggressive disease. Patients with aggressive disease 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 known biomarker available that can predict patient response to standard chemotherapy in HL patients. The Company expects Telo-HLTM 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.
Stage 3 of the Telo-HLTM validation program, as set out in the Company’s news release dated February 23, 2017, included the analysis of over 400 retrospective HL cases to generate a quality controlled data set of 200 patients. The analysis comprised performing a wet lab co-immuno-telomeres FISH assay, 3-dimensional imaging, Hodgkin and Reed-Sternberg cell selection and TeloViewTM software analysis. The assay was performed on the diagnostic lymph node tissue from HL patients. A minimum of 30 Hodgkin’s cells and 30 Reed-Sternberg cells were analyzed from each of the 200 patient specimens. The Clinical Trial was multicentre with HL tissue sourced from three national and international university hospitals.
“I was impressed with the technical proficiency displayed in performing the assay and the overall concordance of HL cell identification,” noted Dr. Hans Knecht, 3DS advisor, Professor of Medicine and Chief, Division of Hematology at Jewish General Hospital, and Director, Division of Hematology, Department of Medicine, McGill University, Montreal. “Most important was the notable quality control and quality assurance standards that were employed during the cell identification process,” Dr. Knecht added.
Stage 3 data has been submitted to the Company’s statistics consulting partner, BioStat Solutions Inc., Maryland, USA (“BSSI”). BSSI will carry out statistical evaluation of the data and develop a scoring model to distinguish patients with non-aggressive disease from patients with aggressive disease that may relapse within 12 months of treatment with standard first-line chemotherapy. BSSI’s statistical analysis will generate Telo-HLTM’s characteristics including positive predictive value, negative predictive value, specificity and sensitivity, with a target performance of greater than 90% on all characteristics. The 3DS clinical development team has started processing an independent patient cohort of over 100 HL cases that will be used to validate the scoring model from BSSI.
3DS also announced today that the United States Patent and Trademark Office has recently issued the Company two new patents governing key aspects of its technology platform. US Patent 9,784,666, entitled “Methods for Assessing Cancer Cells Using Granulometry”, covers a high-resolution imaging technology for assessing cancer progression. US Patent 9,758,830, entitled “Methods for Evaluating Alzheimer’s Disease and Disease Severity”, covers the stratification of Alzheimer’s patients using 3DS technology.
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 website at: http://www.3dsignatures.com.
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.
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This news release contains forward-looking information that is based on current expectations. Statements with respect to the date of, and 3DS’ ability to launch Telo-HLTM as a laboratory developed test by the end of the first calendar quarter of 2018, or at all, the expected design, functionality, benefits and cost savings associated with the Telo-HLTM, the completion and results of BSSI’s evaluation of the Telo-HLTM test and the results of Stage 3 of the Clinical Trial, objectives and priorities, strategies or future actions, research and development, product development, and the effectiveness of 3DS’ technology, among others, are all forward-looking information. Forward-looking information consist of statements that are not purely historical, including any statements regarding beliefs, plans, expectations or intentions regarding the future. Such information can generally be identified by the use of forward-looking wording such as “will”, “may”, “expect”, “estimate”, “anticipate”, “intend”, “believe” and “continue” or the negative thereof or similar variations. Readers are cautioned not to place undue reliance on forward-looking information, as there can be no assurance that the plans, intentions or expectations upon which they are based will occur. By their nature, forward-looking information involve numerous assumptions and known and unknown risks and uncertainties, both general and specific, that contribute to the possibility that the predictions, estimates, forecasts, projections and other forward-looking information will not occur. These assumptions include, among other things 3DS’ ability to launch the Telo-HLTM as a laboratory developed test, the design, functionality, benefits and cost savings associated with the Telo-HLTM conforming to expectations, the existence of an alternative biomarker available that can predict patient response to standard chemotherapy in HL patients, BSSI’s completion of its evaluation of the Telo-HLTM test and the results of Stage 3 of the Clinical Trial, the state of the economy in general and capital markets in particular, and other factors, many of which are beyond the control of the Company. 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: that the Company may not be able to launch the Telo-HLTM as a laboratory developed test by the end of the first calendar quarter of 2018, or at all; that, upon launch, the Telo-HLTM may not confirm to current expectations in respect of its design, functionality, benefits and cost savings; the existence of another biomarker that can predict patient response to standard chemotherapy in HL patients, BSSI not completing its evaluation of the Telo-HLTMtest and the results of Stage 3 of the Clinical Trial, or such evaluation not conforming to current expectations; 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. The Company cautions the reader that the above list of risk factors is not exhaustive. Important factors that could cause actual results to differ materially from the Company’s expectations include: litigation, the condition of the global economy, loss of key employees and consultants, additional funding requirements, changes in laws, technology failures, competition, and the failure of counterparties to perform their contractual obligations. The forward-looking information contained in this news release is expressly qualified by this cautionary statement. Such information should not be read as a guarantee of future performance or results. Such information involves known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements.
The forward-looking information contained in this news release is made as of the date of this news release. Except as required by law, the Company disclaims any intention and assumes no obligation to update or revise any forward-looking information, whether as a result of new information, events or otherwise. Additionally, the Company undertakes no obligation to comment on the expectations of, or statements made by, third parties in respect of the matters discussed above.
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.