Theralase® Phase II NMIBC Clinical Study (Interim) Data to be Presented at the AUA Annual Meeting
Theralase Technologies Inc. (TLTFF) announced that its Phase II study on Bacillus Calmette Guerin (BCG) Unresponsive Non-Muscle Invasive Bladder Cancer has had its interim data accepted for presentation at the American Urology Association (AUA) annual meeting from April 28 to May 1, 2023. The clinical study aims to treat 100-125 patients, using TLD-1433 activated by their TLC-3200 laser system. Interim results show a complete response rate of 53% at 90 days and 28% at 450 days, suggesting PDT could be a viable treatment option with a favorable safety profile.
- Phase II clinical study interim results show a 53% complete response rate at 90 days.
- 28% of patients evaluated at 450 days showed a complete response.
- Opportunity to showcase data at AUA annual meeting to leading uro-oncologists globally.
- None.
TORONTO, Feb. 02, 2023 (GLOBE NEWSWIRE) -- Theralase® Technologies Inc. (“Theralase®” or the “Company”) (TSXV: TLT) (OTCQB: TLTFF), a clinical stage pharmaceutical company focused on the research and development of light activated Photo Dynamic Compounds (“PDCs”) and their associated drug formulations, used to safely and effectively destroy various cancers, bacteria and viruses, announced today that its Phase II Bacillus Calmette Guerin (“BCG”) Unresponsive Non-Muscle Invasive Bladder Cancer (“NMIBC”) Carcinoma In-Situ (“CIS”) clinical study (“Study II”) (Interim) data has been accepted by the American Urology Association (“AUA”) for a moderated poster presentation at its annual meeting.
The AUA annual meeting will take place between April 28th to May 1st, 2023 in Chicago, Illinois with the poster presented for general viewing and discussion within one of the moderated poster sessions, during the AUA annual meeting.
The poster titled: “A Phase II Clinical Study of Intravesical Photo Dynamic Therapy (“PDT”) in Patients with BCG-Unresponsive NMIBC (interim analysis)” will be presented by the lead author, Girish Kulkarni M.D., Ph.D., FRCSC, Divisions of Urology and Surgical Oncology, Department of Surgery, Princess Margaret Cancer Centre, University Health Network, Professor, University of Toronto, (Toronto, Ontario, Canada).
The poster will include interim clinical data and analysis collected through the enrollment and treatment of patients at all Canadian and US clinical study site by their respective principal investigators for Study II.
Arkady Mandel MD, Ph.D., D.Sc., Interim Chief Executive Officer and Chief Scientific Officer, Theralase® stated, “I am delighted that Theralase® will have the opportunity to showcase its latest reported interim clinical data and analysis for Study II at the AUA annual meeting to leading uro-oncologists from around the world. The interim analysis of the clinical data collected from Study II to date supports that early results show complete response rates in
About AUA
Founded in 1902, with more than 20,000 members worldwide, the AUA is a premier urologic association, providing invaluable support to the urologic community with the mission is to promote the highest standards of urological clinical care through education, research and the formulation of health care policy.
About Study II
Study II utilizes the therapeutic dose of TLD-1433 (0.70 mg/cm2) activated by the proprietary TLC-3200 medical laser system. Study II is focused on enrolling and treating approximately 100 to 125 BCG-Unresponsive NMIBC CIS patients in up to 20 clinical study sites located in Canada and the United States.
About TLD-1433
TLD-1433 is a patented PDC with 12 years of published peer reviewed preclinical research and is currently under investigation in Study II.
About Theralase® Technologies Inc.
Theralase® is a clinical stage pharmaceutical company dedicated to the research and development of light activated compounds and their associated drug formulations with a primary objective of efficacy and a secondary objective of safety in the destruction of various cancers, bacteria and viruses.
Additional information is available at www.theralase.com and www.sedar.com
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, including 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 to 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, and the impacts of public health crises, such as COVID-19. 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 successfully come to fruition, 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.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchanges) accepts responsibility for the adequacy or accuracy of this release.
For More Information:
Kristina Hachey, CPA
Chief Financial Officer
1.866.THE.LASE (843.5273)
416.699.LASE (5273)
khachey@theralase.com
www.theralase.com
FAQ
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