WINNIPEG, MB--(Marketwired - October 19, 2016) - 3D Signatures Inc. (TSX VENTURE: DXD) (the "Company" or "3DS") is pleased to announce its participation in a major clinical trial for prostate cancer diagnosis and management known as PRECISE. This trial marks the Company's first step toward validation and approval of clinical risk assessment tests for prostate cancer.
PRECISE (PRostate Evaluation for Clinically Important disease MRI vs Standard Evaluation procedures) is led by renowned uro-oncologist and prostate cancer thought leader, Dr. Laurence Klotz. Dr. Klotz is the Chairman of the Canadian Urology Research Consortium (the "CURC"), the study sponsor. It is the first randomized, multicenter study focused on biopsy naive patients (approximately 450 men) with clinical suspicion of prostate cancer. The 24-month prospective study is principally designed to compare cancer detection rates and monitoring efficacy of TRUS guided biopsy versus MRI targeted biopsy, two existing surgical tools employed in the diagnosis and monitoring of prostate cancer patients. PRECISE will incorporate 3DS' blood-based tests into the original biopsy focused investigation as a correlative biomarker. 3DS' participation seeks to establish a baseline of genomic instability for prostate cancer patients, provide follow-up monitoring information and provide essential data for developing several blood-based clinical tests for personalized assessment and treatment of prostate cancer patients.
"The PRECISE trial aims to determine whether MRI, a non-invasive imaging test, can replace invasive prostate biopsies in men with an elevated PSA," said Principal Investigator, Dr. Klotz. "We have an opportunity to test a new blood-based biomarker to accurately stratify patients into risk groups. If successful, this could represent a first-in-class blood test which would specifically identify clinically significant prostate cancer. Such a tool does not currently exist for prostate cancer patients."
Awarded by way of a rigorous peer review process run by Prostate Cancer Canada, this multimillion dollar project is funded by the Ontario Institute for Cancer Research (OICR) and the Movember Foundation Canada. To support its participation in PRECISE and the development of related clinical tests, 3DS' projected budget is approximately $2.4M over a two-year period which represents at least 50% savings over an independently run study.
Prostate cancer -- precision medicine and unmet need
There is a significant unmet need for accurate and minimally invasive risk-assessment tools to allow clinicians to make better treatment decisions for prostate cancer patients. There are approximately 300,000 new prostate cancer patients diagnosed in the US and Canada each year. About 50% of newly diagnosed patients have a mild form of the disease, and do not need initial treatment; however, a significant proportion of these patients are over-treated because clinicians lack reliable and/or minimally invasive tests. The overtreatment of clinically insignificant prostate cancer costs the healthcare system hundreds of millions of dollars annually. Active Surveillance, an emerging standard of care, seeks to reduce unnecessary biopsies and treatments and the costs associated with patient care. It is a strategic choice for patients, physicians, health care systems, and insurance providers, both public and private.
3DS wants to facilitate personalized treatment decisions for each individual prostate cancer patient with the following objectives:
- Identify the right men for the right treatment
- Accurately monitor men during treatment
- Reduce the number of men undergoing unnecessary prostate biopsies
- Reduce the number of biopsies over time (for each patient)
- Reduce biopsy-related adverse events including infection and pain
- Reduce the over-diagnosis and overtreatment of clinically insignificant prostate cancer
- Reduce the economic burden of diagnosing and treating prostate cancer
About 3D Signatures Inc.
3D Signatures Inc. (TSX VENTURE: DXD) is a novel personalized medicine company with a proprietary software platform based on the analysis of a patient's three-dimensional chromosomal signature. The technology is well developed and supported by 16 clinical studies on over 1,500 patients on 13 different cancers and Alzheimer's disease. Depending on the application, the 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.
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