Theralase(R) Expands Clinical Team
Theralase Technologies Inc. announces the addition of two Clinical Research Associates to its team to support the Phase II registration bladder cancer clinical study. The CRAs will facilitate the launch of new clinical study sites, patient enrollment, data review, ethics board approval, training, and Break Through Designation approval from the FDA. The company aims to commercialize RuvidarTM to provide a safe and effective treatment for bladder cancer patients.
Expansion of the clinical team with two experienced Clinical Research Associates to support the Phase II registration bladder cancer clinical study.
Focus on launching new clinical study sites in Canada and the United States to expand patient reach and enrollment.
Commitment to reviewing and analyzing existing clinical data for accuracy to ensure the success of the ongoing Phase II clinical study.
Efforts to secure review ethics board approval and patient consent for obtaining patient clinical data up to 3 years post Study Procedure.
Dedication to providing training and support for central pathology analysis of urine cytology and bladder biopsy pathology samples.
Anticipation of Break Through Designation approval from the FDA in 3Q2024 to expedite the commercialization process of RuvidarTM.
Company's focus on commercializing RuvidarTM to offer a safe and effective treatment for bladder cancer patients globally.
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TORONTO, ON / ACCESSWIRE / May 2, 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 it has expanded its clinical team with the hiring of two Clinical Research Associates ("CRAs").
Effective March 4th and May 1st, 2024, respectively, Bhavya Bajantri M.Sc., CCRP and Sonia Keshwani B.Sc., CCRP have joined Theralase® in the capacity of CRAs.
The roles of the CRAs will be to work with the clinical study sites to successfully complete the Phase II registration bladder cancer clinical study ("Study II") by:
- Launching new clinical study sites in Canada and the United States.
- Enrolling all patients into the clinical study in 2024.
- Reviewing and analyzing the existing clinical data to ensure accuracy.
- Securing review ethics board approval and patient consent to obtain patient clinical data up to 3 years from date of primary Study Procedure.
- Providing training and support on central pathology analysis of urine cytology and bladder biopsy pathology samples.
- Supporting Break Through Designation approval from the FDA in 3Q2024.
Roger DuMoulin-White, President and Chief Executive Officer, Theralase® stated, "The Company looks forward to working with Bhavya and Sonia in their new roles and their participation in the successful and timely completion of Study II. The ultimate goal of our ongoing Phase II clinical study is to commercialize RuvidarTM in Canada, the United States and internationally to provide a safe and effective treatment for as many patients, as possible, who are afflicted with this deadly disease."
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.
Additional information is available at www.theralase.com and www.sedar.com
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 fund and secure the 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 on terms that are commercially favorable to the Company or may not be available at all, 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:
1.866.THE.LASE (843-5273)
416.699.LASE (5273)
www.theralase.com
Kristina Hachey, CPA
Chief Financial Officer
khachey@theralase.com
SOURCE: Theralase Technologies Inc.
View the original press release on accesswire.com
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