Theralase Launches Sixth Clinical Study Site in the US for Phase II Bladder Cancer Clinical Study

Rhea-AI Summary

Theralase Technologies Inc. has received Institutional Review Board approval for its Phase II Clinical Study targeting Non-Muscle Invasive Bladder Cancer (NMIBC) at Urology San Antonio. This site marks the sixth US clinical study site to obtain such approval. Currently, 16 patients are involved in the study, with a target of 25 patients for potential Breakthrough Designation. CEO Shawn Shirazi expressed enthusiasm over meeting clinical site targets and the prospect of expanding patient enrollment in early 2021. Additional sites are anticipated to launch in Q2 and Q3 of 2021.

Positive

• Sixth US clinical study site approved for Phase II NMIBC study.
• 16 patients have already been treated in Study II.
• Targeting 25 patients for potential Breakthrough Designation.

Negative

• None.

TORONTO, ON / ACCESSWIRE / March 25, 2021 / 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 ("PDC") and their associated drug formulations used to safely and effectively destroy various cancers, bacteria and viruses announced today that Urology San Antonio ("USA") has received site Institutional Review Board ("IRB") approval to commence a Pivotal Phase II Non-Muscle Invasive Bladder Cancer ("NMIBC") Clinical Study to enroll and treat patients with Bacillus Calmette Guerin("BCG")-Unresponsive Carcinoma In-Situ ("CIS") or who are intolerant to BCG Therapy ("Study II").

This marks the sixth US Clinical Study Site ("CSS") that has obtained site IRB approval through a central IRB. Theralase is at different stages with additional US clinical study sites that are expected to launch in 2Q21 and 3Q21.

Urology San Antonio is the largest urology practice in South Texas with multiple locations offering care for men and women experiencing complications of the urinary system. Their subspecialists develop incredible expertise in different aspects of urologic care and can offer patients treatment options and guidance not commonly seen in a community urology practice. Dr. Daniel Saltzstein MD will be the Study II Principal Investigator for this site.

To date 16 patients have been treated in Study II. The Company has now launched 5 CSS's in Canada and 6 in the US for patient enrollment and treatment under Study II clinical study guideline.

Shawn Shirazi PhD, Chief Executive Officer, Theralase^®, stated, "It is exciting to see Theralase hit its target of having 6 US clinical sites on board in 1Q 2021. It is truly uplifting to be working on the details of getting patients enrolled and treated at these sites. Theralase is another step closer in achieving its next milestone of enrolling and treating 9 additional patients in early 2021 to meet the target of 25 patients for potential Breakthrough Designation."

About Theralase^® Technologies Inc.

Theralase^® is a clinical stage pharmaceutical company dedicated to the research and development of light activated Photo Dynamic Compounds and their associated drug formulations intended to safely and effectively destroy various cancers, bacteria and viruses.

Additional information is available at www.theralase.com and www.sedar.com.

Forward Looking Statement:

This news release contains "forward-looking statements" which reflect the current expectations of the Company's management for future growth, results of operations, performance, business prospects and opportunities. 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. Wherever possible, words such as "may", "would", "could", "should", "will", "anticipate", "believe", "plan", "expect", "intend", "estimate", "potential for" and similar expressions have been used to identify these forward-looking statements. These statements reflect management's beliefs with respect to future events and are based on information currently available to management. Forward-looking statements involve significant risks, uncertainties and assumptions; including, with respect to the ability of the Company to: adequately fund, secure the requisite regulatory approvals to commence and successfully complete a Phase II NMIBC clinical study in a timely fashion and implement its commercialization plans. Many factors could cause the Company's actual results, performance or achievements to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements; including, without limitation, those listed in the filings made by the Company with the Canadian securities regulatory authorities (which may be viewed at www.sedar.com). Should one or more of these risks or uncertainties materialize or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on 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. The Company disclaims any intention or obligation to revise forward-looking statements whether as a result of new information, future developments or otherwise except as required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.

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.

For More Information:

1.866.THE.LASE (843-5273)
416-699-LASE (5273)
www.theralase.com

Kristina Hachey
Chief Financial Officer
khachey@theralase.com
416-699-LASE (5273) x 224

SOURCE: Theralase Technologies Inc.

View source version on accesswire.com:
https://www.accesswire.com/637239/Theralase-Launches-Sixth-Clinical-Study-Site-in-the-US-for-Phase-II-Bladder-Cancer-Clinical-Study

FAQ

What is the purpose of Theralase's Phase II clinical study?

The Phase II clinical study aims to enroll and treat patients with Bacillus Calmette Guerin (BCG)-unresponsive Carcinoma In-Situ (CIS) or those intolerant to BCG therapy.

When did Theralase announce the approval for the sixth clinical study site?

Theralase announced the approval on March 25, 2021.

How many patients are currently involved in the Phase II NMIBC study?

Currently, 16 patients have been treated in the study.

What is the stock symbol for Theralase Technologies Inc.?

The stock symbol for Theralase is TLTFF on the OTCQB.

What are the next steps for Theralase after this IRB approval?

Theralase aims to enroll and treat 9 additional patients in early 2021 to reach a target of 25 patients for potential Breakthrough Designation.