New Study Shows 3D Signatures' Telomere Analysis May Be an Effective Biomarker for Monitoring High Risk Prostate Cancer Patients

WINNIPEG, MB--(Marketwired - January 09, 2017) - Data from a new study¹ published recently in Urologic Oncology involving men with localized high-risk prostate cancer suggests that the use of 3D Signatures Inc.'s (TSX VENTURE: DXD) (OTCQB: TDSGF) (FRANKFURT: 3D0) (the "Company" or "3DS") technology platform, TeloView™, may be a promising blood-based treatment-response biomarker in prostate cancer patients who are undergoing combined (hormonal) androgen deprivation therapy ("ADT") and radiation therapy ("RT"). Based on distinct 3D telomere signatures before treatment, prostate cancer patients were divided into 3 groups. In all patients, ADT and RT resulted in distinct changes in 3D telomere signatures, which were unique for each of the 3 patient groups.

While the serum prostate-specific antigen test ("PSA") is currently the most common biomarker for prostate cancer, it is widely recognized that PSA results can often indicate the possibility of prostate cancer when none is present. The PSA test is based on the fact that men with higher levels of PSA are more likely to have prostate cancer. However, higher levels of PSA can also be caused by a benign enlargement or inflammation of the prostate, leading to many false-positive diagnoses for cancer. As there is no reliable method to differentiate PSA produced by "cancer" versus "normal" prostate tissue, relying on the PSA test often leads to inaccuracies in monitoring patients after RT.² In fact, many patients thought to have disease recurrence based on rising PSA levels are actually disease-free after longer follow-up,³ reinforcing the need for a new decision-making tool for clinicians.

Dr. Sabine Mai, Chair of 3DS' Clinical and Scientific Advisory Board, Company Director and study senior author commented, "Prostate cancer is a disease of genomic instability with telomere shortening as an early sign of a more aggressive disease. To our knowledge, this is the first and only study to investigate and demonstrate the distinct dynamic changes in 3D telomere signatures after treatment. Our technology could be at the forefront of a paradigm shift in the way prostate cancer is managed and address an urgent unmet need for an accurate blood-based biomarker that currently does not exist."

About the Study

• The accurate assessment and monitoring of therapeutic efficacy of locally advanced prostate cancer remains a major clinical challenge. Contrary to prostate biopsies, circulating tumor cells ("CTCs") are a cellular source obtained by blood sampling and can serve as a surrogate marker for treatment efficacy.
• Size-based filtration was used to isolate and enumerate CTCs from the blood of 20 patients with high-risk (any one of cT3, Gleason 8-10, or PSA > 20 ng/ml), nonmetastatic, and treatment-naive prostate cancer before and after (hormonal) ADT and RT.
• 3D telomere technology testing was performed on isolated CTCs to determine 3D telomere profiles for each patient before and throughout the course of both ADT and RT.
• Based on the distinct 3D telomere signatures of CTCs before treatment, patients were divided into 3 groups. In each patient, ADT and RT resulted in distinct changes in 3D telomere signatures of CTCs, which were unique for each of the 3 patient groups.
• The study concluded that 3D telomere analysis of CTCs can reveal differences in therapeutic responses, providing a new opportunity for better treatment monitoring and management of patients with high-risk prostate cancer.

About 3DS

3DS (TSX VENTURE: DXD) (OTCQB: TDSGF) (FRANKFURT: 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 16 clinical studies on over 1,500 patients on 13 different cancers and Alzheimer's disease. Depending on the desired 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 website at http://www.3dsignatures.com.

Forward-Looking Information

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. In particular, the Company's statements concerning study results recently published are forward-looking statements. 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. In addition, you should note that forward looking statements are made only as of the date of this news release and that we do not assume any obligation to update any forward-looking statements other than as required by law.

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.

References:

¹ L. Wark et al. 2016. Dynamics of three-dimensional telomere profiles of circulating tumor cells in patients with high-risk prostate cancer who are undergoing androgen deprivation and radiation therapies. Urol Oncol 1-11.

² Roach Mack, Hanks Gerald, Thames Howard, Schellhammer Paul, Shipley William U, Sokol Gerald H, et al. Defining biochemical failure following radiotherapy with or without hormonal therapy in men with clinically localized prostate cancer: recommendations of the RTOG- ASTRO Phoenix Consensus Conference. Int J Radiat Oncol Biol Phys 2006;65:965-74, http://dx.doi.org/10.1016/j.ijrobp.2006.04.029.

³ Thompson Anna, Keyes Mira, Pickles Tom, Palma David, Moravan Veronika, Spadinger Ingrid, Lapointe Vincent, et al. Evaluatingthe phoenix definition of biochemical failure after prostate brachytherapy: can PSA kinetics distinguish PSA failures from PSA bounces? Int J Radiat Oncol Biol Phy 2010;78:415-21, http://dx.doi.org/10.1016/j.ijrobp.2009.07.1724.