Tailwinds’ Take: This is a major milestone for 3DS as PRECISE is the first ever large-scale multi-center study focused on men with a clinical suspicion of prostate cancer. It serves to validate their diagnostic technology among potential prostate cancer patients, a huge potential market for DXD.V.
TORONTO, April 27, 2017 (GLOBE NEWSWIRE) — 3D Signatures Inc. (DXD.V) (TDSGF) (3D0.F) (the “Company” or “3DS”) is pleased to announce that it has received the first batch of blood samples for the PRECISE prostate cancer clinical trial (“PRECISE”). The samples were received for processing and analysis at the Company’s new laboratory and corporate headquarters in the MaRS Discovery District, Toronto, Canada.
There is a significant unmet need for accurate and minimally invasive diagnostic and risk-assessment tools to allow clinicians to make better treatment decisions for prostate cancer patients. There are approximately 524,000 new prostate cancer patients diagnosed in the U.S. and Europe each year, and approximately 5.8 million men living with the disease in the U.S. and Europe. Currently, patients face the choice of either living with prostate cancer under active surveillance or pursuing treatment that, while highly efficacious, is also accompanied by significant risk of devastating side effects such as erectile dysfunction, incontinence, bowel complications and infection.
3DS is developing a blood-based diagnostic test for prostate cancer (“Telo-PC”) which is based on the Company’s proprietary TeloViewTM software platform. Recent clinical results indicate that Telo-PC is a promising candidate for an accurate and minimally invasive risk-assessment and monitoring platform with significant benefits over existing testing options:
- Accurate: Data from a 50 patient prostate cancer pilot study focused on men with intermediate risk prostate cancer who underwent radical prostatectomy (“RP”) was very encouraging. Preliminary results indicate that from a blood test prior to RP, TeloViewTM correctly predicted the status/aggressiveness of disease in each of the study’s patients (50/50).i While all patients were diagnosed as intermediate risk using conventional biopsies prior to surgery, only 21 of the 50 patients who underwent RP showed disease upgrading upon post-surgical analysis and therefore were suitable for prostate removal. 29 of the 50 patients did not need RP at that point in time. TeloViewTM correctly predicted that these 29 patients had a stable form of prostate cancer and that the other 21 had progressive disease.
- Blood-based: The current standard of care to diagnose and monitor prostate cancer is generally to carry out a trans-rectal needle biopsy. There are significant advantages to a blood-based test which include reduced incidence of infection and pain, as well as greater convenience and logistical flexibility.
- Full-spectrum: 3DS is developing a blood-based diagnostic test for patients at every stage of prostate cancer. Telo-PC analyzes circulating tumor cells (“CTCs”) from a patient’s blood. The diagnostics industry has faced a historical challenge to isolate CTCs from early stage cancer patients; however, 3DS has recently demonstrated the ability to do so at all stages of prostate cancer.ii
- High-resolution: It is common for an individual prostate cancer patient to have more than one subtype of prostate cancer. Telo-PC is designed to determine the status/aggressiveness of prostate cancer which includes identification and assessment of multiple tumor subtypes (heterogeneity) within a single patient, increasing the scope of understanding of the patient’s disease status.iii
- Dynamic: Telo-PC has the ability to monitor disease status by assessing tumor cells before and after treatment. The technology has identified structural changes in tumor subpopulations as a result of certain treatment regimes.iv The changes identified are specific to each tumor subpopulation and treatment.
“We are honoured to have been chosen to participate in PRECISE,” commented Jason Flowerday, 3DS’ CEO. “This major clinical trial for prostate cancer diagnosis and management provides 3DS with a powerful opportunity to help validate Telo-PC as a first-of-its-kind test which is able to identify if a patient has clinically significant prostate cancer and, if so, should be prioritized for treatment.”
For more information about PRECISE, please see the Company’s press release dated October 19, 2016 (http://www.3dsignatures.com/news/3d-signatures-included-in-major-clinical-trial-for-prostate-cancer).
3DS (DXD.V) (TDSGF) (3D0.F) 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.