Telo Genomics Launches Physician Experience Program in the United States
Telo Genomics Launches Physician Experience Program in the United States
SMART Observational Study a Critical Step Toward Full Platform Availability
SMART 觀察性研究是實現全平台可用性的關鍵一步
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).
安大略省多倫多--（新聞文件公司-2023 年 11 月 16 日）- Telo Genomics Corp.（多倫多證券交易所股票代碼：TELO）（場外交易代碼：TDSGF）（FSE：3DOA），（這 “公司” 要麼 “Telo”）， 一家利用端粒力量的新興分子測試平台提供商很高興地宣佈啓動其醫生體驗計劃——SMART（陰悶性多發性骨髓瘤轉化風險評估）。
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").
SMART是一項觀察性研究，旨在讓美國的癌症治療醫生及其工作人員獲得訂購和使用TeloViewsMM測定的經驗。通過此次發佈，參與的醫生及其護理團隊可以獲得新的分子信息，以幫助被診斷患有悶燒性多發性骨髓瘤（一種痛苦而致命的癌症的前兆）活動性多發性骨髓瘤（“MM”）的患者選擇管理策略。
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 是一種使用三維端粒分析的非侵入性液體活檢，它利用 TeloView 軟件平台來量化基因組不穩定性和轉化風險。該檢測在多倫多Telo的高複雜度ISO批准實驗室進行。
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.
TeloViewSMM 使用三維結構評估來識別轉化爲全期 MM 的高風險患者，這些患者可能受益於早期的治療干預並取得更好的臨床結果。同樣重要的是，TeloViewSMM 可以區分或排除大部分患有更穩定疾病且不需要立即治療的低風險 SMM 患者。這些患者無需進行昂貴的使人衰弱的化療即可獲得更高的生活質量，並且可以使用Telo的測試進行定期監測。
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."
FACP醫學博士理查德·本德爾在評論SMART的推出時說：“令我感到鼓舞的是，正在這些患者群體中尋求新的生物標誌物和新方法。獲得TeloViewSMM測定有望改善我的悶燒性多發性骨髓瘤患者的管理。”Telo臨床顧問委員會主席本德爾博士接着說：“我的診所和其他註冊SMART的診所將爲轉型風險提供更明智的評估，同時幫助Telo Genomics向更廣泛的醫生用戶群介紹TeloViewSMM測定。”
About SMART
關於 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.
SMART（陰悶性多發性骨髓瘤轉化風險評估）觀察方案（TG-SMM-001）是Telo Genomics於2023年11月啓動的一項獲得IRB批准的研究，旨在評估使用TeloViewSMM的臨床和實驗室動態。該協議的評估和批准由IRBAdvarra進行，其成員資格符合加拿大衛生部法規、ICH GCP指南、FDA法規21 CFR第56部分和HHS法規第45部分第46部分中規定的要求。IRB根據美國食品和藥物管理局法規21 CFR第50、56、312和812部分；HHS法規第45 CFR第46部分A-E小節；良好臨床實踐；加拿大衛生部法規；以及三理事會政策聲明行使其職能。Advarra IRB 已根據 IRB #00000971 在 OHRP 和 FDA 註冊。
About TeloViewSMM
關於 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.
TeloViewSMM 是一款業界首款基於端粒的分子工具，它集成了專有的定量分析和人工智能，可評估作爲陰燃性多發性骨髓瘤 (SMM) 疾病轉變預測指標的端粒的三維組織。專有檢測（及相關的平台技術）量化了超出標準表型測量值的轉化/進展風險。目前，美國有超過20萬名患者患有悶燒的多發性骨髓瘤。Teloview-SMM測定的潛在潛在潛在市場每年超過50萬次測試。
About Telo Genomics
關於 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 .
Telo Genomics Corp. 是一家生物技術公司，憑藉強大的應用程序和預測/預測解決方案，開創了業內最全面的端粒平台。其中包括腫瘤學和神經系統疾病的液體活檢和相關技術。液體活檢是一個快速增長的領域，引起了醫學界的濃厚興趣，因爲與傳統的診斷方法相比，液體活檢的侵入性更小，更容易複製。通過將我們團隊在三維端粒定量分析方面的豐富專業知識與分子生物學和人工智能相結合，以識別與疾病相關的遺傳不穩定性，Telo正在開發簡單而準確的產品，通過滿足病理學家、臨床醫生、學術研究人員和藥物開發人員的需求，改善患者的日常護理。我們專有技術的益處已在 160 多篇同行評審出版物和 30 多項臨床研究中得到證實，涉及 3,000 多名患有多種癌症和阿爾茨海默病的患者。我們的主要應用程序TeloView-mm正在開發中，旨在爲治療多發性骨髓瘤（一種致命的血液癌）的醫療專業人員提供重要、可操作的信息。欲了解更多信息，請訪問。
For further information, please contact:
欲了解更多信息，請聯繫：
Kris Weinberg, CEO
678-429-5582
kris.weinberg@telodx.com
MaRS Centre, South Tower,
101 College Street, Suite 200, Toronto, ON, M5G 1L7
首席執行官克里斯·溫伯格
678-429-5582
kris.weinberg@telodx.com
MarS 中心、南塔、
安大略省多倫多市學院街 101 號 200 號套房，M5G 1L7
Cautionary Note Regarding Forward-Looking Statements
關於前瞻性陳述的警示說明
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.
根據加拿大證券立法，此處包含的某些信息可能構成 “前瞻性信息”。通常，前瞻性信息可以通過使用前瞻性術語來識別，例如 “打算”、“意願”，或者某些行動、事件或結果 “將” 發生的詞語和短語或陳述的變體。關於產品臨床療效、產品的商業可行性、收益用途和TeloView能力的前瞻性陳述 提供可帶來更好治療和療效的個性化藥物的平台基於公司的估計，受已知和未知的風險、不確定性和其他因素的影響，這些因素可能導致公司的實際結果、活動水平、業績或成就與此類前瞻性陳述或前瞻性信息（包括資本支出和其他成本）所表達或暗示的結果存在重大差異。無法保證此類陳述會被證明是準確的，因爲實際結果和未來事件可能與此類聲明中的預期存在重大差異。因此，讀者不應過分依賴前瞻性陳述和前瞻性信息。除非適用的證券法要求，否則公司不會更新此處以引用方式納入的任何前瞻性陳述或前瞻性信息。
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