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Dr. Michael Jewett Joins Theralase(R) to Help Complete Enrollment in the Phase II Non-Muscle Invasive Bladder Cancer Clinical Study

Dr. Michael Jewett Joins Theralase(R) to Help Complete Enrollment in the Phase II Non-Muscle Invasive Bladder Cancer Clinical Study

邁克爾·朱維特博士加入Theralase(R),幫助完成II期非肌肉浸潤性膀胱癌臨床研究的入組
Accesswire ·  02/08 07:00

TORONTO, ON / ACCESSWIRE / February 8, 2024 / Theralase Technologies Inc. ("Theralase" or the "Company") (TSXV:TLT)(OTCQB:TLTFF), a clinical stage pharmaceutical company dedicated to the research and development of light and/or radiation activated Photo Dynamic Compounds ("PDCs") for the safe and effective destruction of various cancers, bacteria and viruses is pleased to announce that Dr. Michael Jewett has joined Theralase, in the role of an independent consultant, to assist the Company in the completion of enrollment of patients in the Phase II Bacillus Calmette-Guérin ("BCG")-Unresponsive Non Muscle Invasive Bladder Cancer ("NMIBC") Carcinoma In-Situ ("CIS") clinical study ("Study II").

安大略省多倫多/ACCESSWIRE/2024 年 2 月 8 日/Theralase Technologies Inc.(“Theralase” 或 “公司”)(多倫多證券交易所股票代碼:TLT)(OTCQB: TLTFF)是一家臨床階段的製藥公司,致力於研發用於安全有效地消滅各種癌症、細菌和病毒的光和/或輻射活化光動力化合物(“PDC”),很高興地宣佈,邁克爾·朱維特博士已加入Theralase,擔任該職務獨立顧問,協助公司完成二期卡爾梅特-蓋林芽孢桿菌(“BCG”)-無反應的非肌肉患者的入組浸潤性膀胱癌(“NMIBC”)原位癌(“CIS”)臨床研究(“研究二”)。

Under the terms of the consulting agreement, Dr. Jewett will be responsible for working with existing clinical study sites and helping to onboard new clinical study sites to allow Theralase to complete enrollment and provide the primary study treatment to all 100 patients in Study II, preferably by December 31, 2024.

根據諮詢協議的條款,Jewett博士將負責與現有臨床研究場所合作,並幫助新臨床研究場所的入組,以使Theralase能夠完成第二項研究中的所有100名患者入組,並提供初級研究治療,最好是在2024年12月31日之前。

To date Theralase has enrolled 63 patients in Study II.

迄今爲止,Theralase已在第二項研究中招收了63名患者。

If all 100 patients are enrolled in Study II by the end of 2024 / beginning of 2025, this will allow Theralase the opportunity to complete the primary follow-up of patients by mid-2026 and place the Company in the coveted position for potential Health Canada and FDA regulatory approval by end or 2026 / beginning of 2027.

如果到2024年底/2025年初將所有100名患者都納入第二項研究,這將使Theralase有機會在2026年年中之前完成對患者的初步隨訪,並使該公司在2026年底或2027年初之前成爲加拿大衛生部和美國食品藥品管理局監管部門批准的夢寐以求的地位。

Dr. Michael Jewett brings an impressive resume to Theralase, including being appointed to the Order of Canada in December 2020 for his life-saving innovations in surgical oncology and for his advocacy of patient-centered clinical care. The Order of Canada is one of Canada's highest civilian honors, recognizing outstanding achievement, dedication to the community and service to the nation.

邁克爾·朱維特博士爲Theralase帶來了令人印象深刻的履歷,包括因其在外科腫瘤學領域的挽救生命的創新以及倡導以患者爲中心的臨床護理而於2020年12月被任命爲加拿大騎士團。加拿大勳章是加拿大最高的平民榮譽之一,旨在表彰傑出成就、對社區的奉獻和對國家的服務。

Dr. Jewett is a Professor of Surgery (Urology) at the Princess Margaret Cancer Centre and at the University of Toronto, where he held the Farquharson Clinical Research Chair in Oncology.

Jewett博士是瑪格麗特公主癌症中心和多倫多大學的外科(泌尿外科)教授,他曾在多倫多大學擔任Farquharson腫瘤學臨床研究主席。

Dr. Jewett has received awards from many cancer and urological associations, including the: International Society of Urology, Society of Urologic Oncology, American Society of Clinical Oncology, American Urological Association and Canadian Urology Association.

Jewett博士曾獲得許多癌症和泌尿外科協會的獎項,包括:國際泌尿外科學會、泌尿外科腫瘤學會、美國臨床腫瘤學會、美國泌尿外科學會和加拿大泌尿外科協會。

Roger DuMoulin-White, President and Chief Executive Officer of Theralase stated that, "I am delighted that Michael has accepted to join the Company in his new role as an independent consultant to work with the clinical study sites to complete enrollment and provide the primary study treatment to 100 patients in total in Study II by the end of 2024. I strongly believe under Michael's leadership and direction that the Company will be able to achieve this strategic objective. I look forward to working with him in his new capacity."

Theralase總裁兼首席執行官羅傑·杜穆林-懷特表示:“我很高興邁克爾同意加入公司,擔任獨立顧問的新職務,與臨床研究機構合作,在2024年底之前完成第二項研究的招募併爲總共100名患者提供初級研究治療。我堅信,在邁克爾的領導和指導下,公司將能夠實現這一戰略目標。我期待着以他的新身份與他合作。”

Dr. Arkady Mandel, Chief Scientific Officer stated that, "I look forward to working with Michael in his new role, as I believe the Theralase photodynamic therapy technology provides a therapy which is fast, safe and provides a significant duration of efficacy for patients afflicted with high-grade NMIBC, who face an unmet need. For patients diagnosed with BCG-Unresponsive NMIBC CIS, the Company recently reported an initial efficacy (clinical complete response) at any evaluated point in time of 64%, with a duration of that efficacy of 36% at 15 months. It is even more impressive that a majority of patients achieved these efficacy responses after only one Ruvidar treatment. Analyzing patients with a total response (cancer destroyed in the bladder, but cancer still detected in urine), the initial efficacy increased to 75% and a duration of that efficacy of 40% (43% for patients who received the optimised treatment) at 15 months. These are very strong efficacy numbers for this patient population. The high safety profile is also appealing as there have been no serious adverse events directly related to the study drug or study device."

首席科學官阿爾卡迪·曼德爾博士表示:“我期待與邁克爾在新職位上合作,因爲我相信Theralase光動力療法技術提供了一種快速、安全的療法,可爲患有高等級NMIBC但需求未得到滿足的患者提供長時間的療法。對於被診斷爲BCG無反應的NMIBC CIS的患者,該公司最近報告稱,在任何評估時間點的初始療效(臨床完全反應)均爲64%,在15個月時療效持續36%。更令人印象深刻的是,大多數患者僅在接受一次Ruvidar治療後就取得了這些療效反應。分析具有總反應的患者(膀胱中的癌症被破壞,但尿液中仍能檢測到癌症),在15個月時,初始療效提高到75%,療效持續時間爲40%(接受優化治療的患者爲43%)。對於這些患者群體來說,這些是非常強的療效數字。高安全性也很有吸引力,因爲沒有發生與研究藥物或研究設備直接相關的嚴重不良事件。”

Dr. Michael Jewett stated that, "I am delighted to be working with the Theralase team again, as I was actively involved in both the Phase Ib clinical study and the commencement of Study II. I strongly believe in the safety and efficacy of the Theralase technology in effectively treating patients diagnosed with BCG-Unresponsive NMIBC CIS. The Theralase technology, in a majority of cases, involves only one treatment versus months of therapy with immunotherapy and/or chemotherapy drugs and has only mild to moderate side effects that are easily managed and often resolve in days. I am impressed that a Canadian-based technology has the potential to make a significant impact on the world stage."

邁克爾·朱維特博士表示:“我很高興再次與Theralase團隊合作,因爲我積極參與了Ib期臨床研究和第二項研究的開始。我堅信Theralase技術在有效治療被診斷爲BCG無反應的NMIBC CIS患者方面的安全性和有效性。在大多數情況下,Theralase技術僅涉及一種治療,而使用免疫療法和/或化療藥物則需要數月的治療,並且只有輕度至中度的副作用,易於控制,通常會在幾天內消失。一項基於加拿大的技術有可能對世界舞臺產生重大影響,這給我留下了深刻的印象。”

About Theralase Technologies Inc.:

關於 Theralase 科技公司:

Theralase is a clinical stage pharmaceutical company dedicated to the research and development of light activated compounds, their associated drug formulations and the light systems that activate them, with a primary objective of efficacy and a secondary objective of safety in the destruction of various cancers, bacteria and viruses.

Theralase是一家臨床階段的製藥公司,致力於研究和開發光活化合物、其相關藥物配方和激活它們的光系統,其主要目標是療效,次要目標是銷燬各種癌症、細菌和病毒的安全性。

Additional information is available at and

更多信息可在和

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

多倫多證券交易所風險投資交易所及其監管服務提供商(該術語在多倫多證券交易所風險交易所的政策中定義)均不對本新聞稿的充分性或準確性承擔責任。

Forward Looking Statements:

前瞻性陳述:

This news release contains "forward-looking statements" within the meaning of applicable Canadian securities laws. Such statements include; but, are not limited to statements regarding the Company's proposed development plans with respect to Photo Dynamic Compounds and their drug formulations. Forward looking statements may be identified by the use of the words "may, "should", "will", "anticipates", "believes", "plans", "expects", "estimate", "potential for" and similar expressions; including, statements related to the current expectations of Company's management for future research, development and commercialization of the Company's Photo Dynamic Compounds and their drug formulations, preclinical research, clinical studies and regulatory approvals.

本新聞稿包含適用的加拿大證券法所指的 “前瞻性陳述”。此類聲明包括;但不限於有關公司擬議的光動力學化合物及其藥物配方的開發計劃的聲明。前瞻性陳述可以通過使用 “可能、“應該”、“將”、“預期”、“相信”、“計劃”、“預期”、“估計”、“潛力” 等詞語來識別;包括與公司管理層當前對公司光動力化合物及其藥物配方、臨床前研究、臨床研究和監管批准的未來研究、開發和商業化的預期相關的陳述。

These statements involve significant risks, uncertainties and assumptions; including, the ability of the Company to adequately fund, and secure the requisite regulatory approvals to successfully complete a Phase II NMIBC clinical study in a timely fashion and implement its development plans. Other risks include: the ability of the Company to successfully commercialize its drug formulations, the risk that access to sufficient capital to fund the Company's operations may not be available or may not be available on terms that are commercially favorable to the Company, the risk that the Company's drug formulations may not be effective against the diseases tested in its clinical studies, the risk that the Company's fails to comply with the term of license agreements with third parties and as a result loses the right to use key intellectual property in its business, the Company's ability to protect its intellectual property, the timing and success of submission, acceptance and approval of regulatory filings. Many of these factors that will determine actual results are beyond the Company's ability to control or predict.

這些陳述涉及重大風險、不確定性和假設;包括公司爲成功及時完成NMIBC二期臨床研究和實施其發展計劃提供充足資金和獲得必要的監管批准的能力。其他風險包括:公司成功將其藥物製劑商業化的能力、可能無法獲得或可能無法按照對公司商業有利的條件獲得足夠資金的風險、公司的藥物配方可能對臨床研究中測試的疾病無效的風險、公司未能遵守與第三方簽訂的許可協議條款從而造成損失的風險在其中的關鍵知識產權的使用權業務、公司保護其知識產權的能力、提交、接受和批准監管文件的時機和成功程度。這些決定實際業績的因素中有許多超出了公司的控制或預測能力。

Readers should not unduly rely on these forward- looking statements which are not a guarantee of future performance. There can be no assurance that forward looking statements will prove to be accurate as such forward looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results or future events to differ materially from the forward-looking statements.

讀者不應過分依賴這些前瞻性的陳述,這些陳述並不能保證未來的表現。無法保證前瞻性陳述會被證明是準確的,因爲此類前瞻性陳述涉及已知和未知的風險、不確定性和其他因素,這些因素可能導致實際結果或未來事件與前瞻性陳述存在重大差異。

Although the forward-looking statements contained in the press release are based upon what management currently believes to be reasonable assumptions, the Company cannot assure prospective investors that actual results, performance or achievements will be consistent with these forward-looking statements.

儘管新聞稿中包含的前瞻性陳述基於管理層目前認爲的合理假設,但公司無法向潛在投資者保證實際業績、業績或成就將與這些前瞻性陳述一致。

All forward-looking statements are made as of the date hereof and are subject to change. Except as required by law, the Company assumes no obligation to update such statements.

所有前瞻性陳述均自本文發佈之日起作出,可能會發生變化。除非法律要求,否則公司沒有義務更新此類聲明。

For More Information:

欲了解更多信息:

1.866.THE.LASE (843-5273)
416.699.LASE (5273)

1.866..LASE (843-5273)
416.699.LASE (5273)

Kristina Hachey, CPA
Chief Financial Officer
khachey@theralase.com

克里斯蒂娜·哈奇,註冊會計師
首席財務官
khachey@theralase.com

SOURCE: Theralase Technologies Inc.

資料來源:Theralase Technologies


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