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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

迈克尔·朱维特博士加入Theralase(R),帮助完成II期非肌肉浸润性膀胱癌临床研究的入组
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").

安大略省多伦多/ACCESSWIRE/2024 年 2 月 8 日/Theralase Technologies Inc.(“Theralase” 或 “公司”)(多伦多证券交易所股票代码:TLT)(OTCQB: TLTFF)是一家临床阶段的制药公司,致力于研发用于安全有效地消灭各种癌症、细菌和病毒的光和/或辐射活化光动力化合物(“PDC”),很高兴地宣布,迈克尔·朱维特博士已加入Theralase,担任该职务独立顾问,协助公司完成二期卡尔梅特-盖林芽孢杆菌(“BCG”)-无反应的非肌肉患者的入组浸润性膀胱癌(“NMIBC”)原位癌(“CIS”)临床研究(“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.

根据咨询协议的条款,Jewett博士将负责与现有临床研究场所合作,并帮助新临床研究场所的入组,以使Theralase能够完成第二项研究中的所有100名患者入组,并提供初级研究治疗,最好是在2024年12月31日之前。

To date Theralase has enrolled 63 patients in Study II.

迄今为止,Theralase已在第二项研究中招收了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年初将所有100名患者都纳入第二项研究,这将使Theralase有机会在2026年年中之前完成对患者的初步随访,并使该公司在2026年底或2027年初之前成为加拿大卫生部和美国食品药品管理局监管部门批准的梦寐以求的地位。

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.

迈克尔·朱维特博士为Theralase带来了令人印象深刻的履历,包括因其在外科肿瘤学领域的挽救生命的创新以及倡导以患者为中心的临床护理而于2020年12月被任命为加拿大骑士团。加拿大勋章是加拿大最高的平民荣誉之一,旨在表彰杰出成就、对社区的奉献和对国家的服务。

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博士是玛格丽特公主癌症中心和多伦多大学的外科(泌尿外科)教授,他曾在多伦多大学担任Farquharson肿瘤学临床研究主席。

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博士曾获得许多癌症和泌尿外科协会的奖项,包括:国际泌尿外科学会、泌尿外科肿瘤学会、美国临床肿瘤学会、美国泌尿外科学会和加拿大泌尿外科协会。

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总裁兼首席执行官罗杰·杜穆林-怀特表示:“我很高兴迈克尔同意加入公司,担任独立顾问的新职务,与临床研究机构合作,在2024年底之前完成第二项研究的招募并为总共100名患者提供初级研究治疗。我坚信,在迈克尔的领导和指导下,公司将能够实现这一战略目标。我期待着以他的新身份与他合作。”

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."

首席科学官阿尔卡迪·曼德尔博士表示:“我期待与迈克尔在新职位上合作,因为我相信Theralase光动力疗法技术提供了一种快速、安全的疗法,可为患有高等级NMIBC但需求未得到满足的患者提供长时间的疗法。对于被诊断为BCG无反应的NMIBC CIS的患者,该公司最近报告称,在任何评估时间点的初始疗效(临床完全反应)均为64%,在15个月时疗效持续36%。更令人印象深刻的是,大多数患者仅在接受一次Ruvidar治疗后就取得了这些疗效反应。分析具有总反应的患者(膀胱中的癌症被破坏,但尿液中仍能检测到癌症),在15个月时,初始疗效提高到75%,疗效持续时间为40%(接受优化治疗的患者为43%)。对于这些患者群体来说,这些是非常强的疗效数字。高安全性也很有吸引力,因为没有发生与研究药物或研究设备直接相关的严重不良事件。”

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."

迈克尔·朱维特博士表示:“我很高兴再次与Theralase团队合作,因为我积极参与了Ib期临床研究和第二项研究的开始。我坚信Theralase技术在有效治疗被诊断为BCG无反应的NMIBC CIS患者方面的安全性和有效性。在大多数情况下,Theralase技术仅涉及一种治疗,而使用免疫疗法和/或化疗药物则需要数月的治疗,并且只有轻度至中度的副作用,易于控制,通常会在几天内消失。一项基于加拿大的技术有可能对世界舞台产生重大影响,这给我留下了深刻的印象。”

About Theralase Technologies Inc.:

关于 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是一家临床阶段的制药公司,致力于研究和开发光活化合物、其相关药物配方和激活它们的光系统,其主要目标是疗效,次要目标是销毁各种癌症、细菌和病毒的安全性。

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.

多伦多证券交易所风险投资交易所及其监管服务提供商(该术语在多伦多证券交易所风险交易所的政策中定义)均不对本新闻稿的充分性或准确性承担责任。

Forward Looking Statements:

前瞻性陈述:

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.

本新闻稿包含适用的加拿大证券法所指的 “前瞻性陈述”。此类声明包括;但不限于有关公司拟议的光动力学化合物及其药物配方的开发计划的声明。前瞻性陈述可以通过使用 “可能、“应该”、“将”、“预期”、“相信”、“计划”、“预期”、“估计”、“潜力” 等词语来识别;包括与公司管理层当前对公司光动力化合物及其药物配方、临床前研究、临床研究和监管批准的未来研究、开发和商业化的预期相关的陈述。

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.

这些陈述涉及重大风险、不确定性和假设;包括公司为成功及时完成NMIBC二期临床研究和实施其发展计划提供充足资金和获得必要的监管批准的能力。其他风险包括:公司成功将其药物制剂商业化的能力、可能无法获得或可能无法按照对公司商业有利的条件获得足够资金的风险、公司的药物配方可能对临床研究中测试的疾病无效的风险、公司未能遵守与第三方签订的许可协议条款从而造成损失的风险在其中的关键知识产权的使用权业务、公司保护其知识产权的能力、提交、接受和批准监管文件的时机和成功程度。这些决定实际业绩的因素中有许多超出了公司的控制或预测能力。

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.

读者不应过分依赖这些前瞻性的陈述,这些陈述并不能保证未来的表现。无法保证前瞻性陈述会被证明是准确的,因为此类前瞻性陈述涉及已知和未知的风险、不确定性和其他因素,这些因素可能导致实际结果或未来事件与前瞻性陈述存在重大差异。

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.

尽管新闻稿中包含的前瞻性陈述基于管理层目前认为的合理假设,但公司无法向潜在投资者保证实际业绩、业绩或成就将与这些前瞻性陈述一致。

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.

所有前瞻性陈述均自本文发布之日起作出,可能会发生变化。除非法律要求,否则公司没有义务更新此类声明。

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,注册会计师
首席财务官
khachey@theralase.com

SOURCE: Theralase Technologies Inc.

资料来源:Theralase Technologies


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