SMART Observational Study a Critical Step Toward Full Platform Availability
Toronto, Ontario--(Newsfile Corp. - November 16, 2023) - Telo Genomics Corp. (TSXV: TELO) (OTCQB: TDSGF) (FSE: 3DOA), (the "Company" or "Telo"), an emerging molecular testing platform provider leveraging the power of telomeres, is excited to announce the initiation of their Physician Experience Program - SMART (Smoldering Multiple myeloma Assessment of Risk for Transformation).
SMART is an observational study intended for cancer treating physicians and their staff in the US to gain experience ordering and utilizing the TeloViewSMM assay. With this launch, participating physicians and their care teams have access to novel molecular information to assist in selecting management strategies for their patients diagnosed with Smoldering Multiple Myeloma - a precursor to a painful and deadly form of cancer - active multiple myeloma ("MM").
TeloViewSMM is a non-invasive liquid biopsy, using 3-dimensional telomere analysis, that utilizes the TeloView® software platform to quantify genomic instability and transformation risk. The assay is conducted at Telo's high-complexity ISO-approved lab in Toronto.
TeloViewSMM uses 3D structural assessment to identify patients with high risk of transformation to full stage MM who are likely to benefit from earlier treatment intervention and achieve better clinical outcomes. Just as important, TeloViewSMM can discriminate or rule out the larger subset of low-risk SMM patients who have a more stable form of the disease and do not require immediate treatment. These patients can receive a higher quality of life without costly, debilitating chemotherapy before it is necessary, and can be regularly monitored using Telo's test.
Commenting on the launch of SMART, Richard A. Bender MD, FACP said, "I'm encouraged that new biomarkers and novel approaches are being pursued in this patient population. Having access to the TeloViewSMM assay promises to improve management of my patients with Smoldering Multiple Myeloma." Dr. Bender, Chairman of Telo's Clinical Advisory Board, went on to say, "My practice and others that enroll in SMART will offer a better-informed assessment of transformation risk while helping Telo Genomics introduce the TeloViewSMM assay to a wider physician user base."
About SMART
The SMART (Smoldering Multiple myeloma Assessment of Risk for Transformation) observational protocol (TG-SMM-001) is an IRB-approved study initiated by Telo Genomics in November of 2023 to assess clinical and laboratory dynamics around the use of TeloViewSMM. Evaluation and approval of the protocol were conducted by Advarra, an IRB whose membership complies with the requirements defined in Health Canada regulations, ICH GCP guidelines, FDA regulations at 21 CFR part 56, and HHS regulations at 45 CFR part 46. The IRB carries out its functions in accordance with FDA regulations at 21 CFR parts 50, 56, 312, and 812; HHS regulations at 45 CFR part 46, subparts A-E; good clinical practices; Health Canada regulations; and the Tri-Council Policy Statement. Advarra IRB is registered with OHRP and FDA under IRB #00000971.
About TeloViewSMM
TeloViewSMM is a first-in-class telomere-based molecular tool that integrates proprietary quantitative analytics and artificial intelligence to evaluate the 3D organization of telomeres as a predictor of disease transformation in Smoldering Multiple Myeloma (SMM). The proprietary assay (and associated platform technology) quantifies risk of transformation/progression beyond standard phenotypic measures. Over 200,000 patients in the United States are currently living with smoldering Multiple Myeloma. The TeloView-SMM assay has a potential total addressable market of over 500,000 tests per year.
About Telo Genomics
Telo Genomics Corp. is a biotech company pioneering the most comprehensive telomere platform in the industry with powerful applications and predictive/prognostic solutions. These include liquid biopsies and related technologies in oncology and neurological diseases. Liquid biopsy is a rapidly growing field of significant interest to the medical community for being less invasive and more easily replicated than traditional diagnostic approaches. By combining our team's considerable expertise in quantitative analysis of 3D telomeres with molecular biology and artificial intelligence to recognize disease associated genetic instability, Telo is developing simple and accurate products that improve day-to-day care for patients by serving the needs of pathologists, clinicians, academic researchers and drug developers. The benefits of our proprietary technology have been substantiated in 160+ peer reviewed publications and in 30+ clinical studies involving more than 3,000 patients with multiple cancers and Alzheimer's disease. Our lead application, TeloView-MM is being developed to provide important, actionable information to medical professionals in the treatment of multiple myeloma, a deadly form of blood cancer. For more information, please visit www.telodx.com.
For further information, please contact:
Kris Weinberg, CEO
678-429-5582
kris.weinberg@telodx.com
MaRS Centre, South Tower,
101 College Street, Suite 200, Toronto, ON, M5G 1L7
www.telodx.com
Cautionary Note Regarding Forward-Looking Statements
Certain information contained herein may constitute "forward-looking information" under Canadian securities legislation. Generally, forward-looking information can be identified by the use of forward-looking terminology such as "intends", "will", or variations of such words and phrases or statements that certain actions, events or results "will" occur. Forward-looking statements regarding the clinical efficacy of products, commercial viability of products, use of proceeds, and the ability of the TeloView® platform to deliver personalized medicine resulting in better treatments and outcomes are based on the Company's estimates and are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance or achievements of the Company to be materially different from those expressed or implied by such forward-looking statements or forward-looking information, including capital expenditures and other costs. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements and forward-looking information. The Company will not update any forward-looking statements or forward-looking information that are incorporated by reference herein, except as required by applicable securities laws.
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