V.TLT | February 8th, 2024
Toronto, Ontario – February 8th, 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”).
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.
To date Theralase® has enrolled 63 patients in Study II.
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.
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.
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.
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.
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.”
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.”
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.”
About Theralase® Technologies Inc.:
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.
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.
Forward Looking Statements:
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.
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.
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.
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.
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.
For More Information:
Kristina Hachey, CPA
Chief Financial Officer