Theralase(R) Launches New Clinical Study Site in Canada

Rhea-AI Summary

Theralase Technologies has launched a new clinical study site at St. Joseph's Healthcare Hamilton for its bladder cancer therapy. The company's Phase II registration study investigates RuvidarTM (TLD-1433) activated by the TLC-3200 Medical Laser System for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer.

Key results from 75 enrolled patients show: 61.9% demonstrated Complete Response (CR), increasing to 68.3% when including Indeterminate Response. 43.6% of CR patients maintained response for 12 months, with some showing continued response at 24 and 36 months. The study reported 100% safety with no serious adverse events.

The company now operates 11 clinical sites across North America, with 4 more planned for Q4 2024/Q1 2025. Theralase is seeking partnering opportunities for international commercialization of Ruvidar™, targeting regulatory approval in 2026.

Positive

• 61.9% of treated patients showed Complete Response (CR)
• 68.3% Total Response rate including Indeterminate Response
• 43.6% of CR patients maintained response for 12 months
• 100% safety profile with no serious adverse events
• Expansion to 11 clinical sites with 4 more planned
• ≥53% chance of remaining cancer free for 1 year if CR is obtained

Negative

• Still pending regulatory approval until 2026
• Declining CR maintenance rate over time (53% at 1 year to 24.9% at 3 years)

St. Joseph's Healthcare Hamilton is the latest Canadian clinical study site for clinical investigation of Theralase®'s Anti-Cancer Therapy for the treatment of bladder cancer

TORONTO, ON / ACCESSWIRE / December 5, 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, radiation, sound and/or drug-activated small molecules and their formulations, intended for the safe and effective destruction of various cancers, bacteria and viruses, is pleased to announce that it has launched a new Clinical Study Site ("CSS") for its bladder cancer clinical study; specifically, St. Joseph's Healthcare Hamilton (Hamilton, Ontario, Canada).

Theralase®'s lead drug, Ruvidar^TM (TLD-1433), activated by the TLC-3200 Medical Laser System ("TLC-3200") is currently under clinical investigation in Canada and the United States in a Phase II registration study for Bacillus Calmette-Guérin ("BCG")-Unresponsive Non-Muscle Invasive Bladder Cancer ("NMIBC") Carcinoma In-Situ ("CIS") with or without resected T_a / T₁ papillary disease ("Study II").

An estimated 83,190 patients in the United States¹ and 12,300 patients in Canada² will be diagnosed with bladder cancer in 2024. Bladder cancer was the fourth leading cancer in men in 2023, representing 6% of estimated new cancers and 4% of cancer related deaths.

Study II is a Phase 2, single arm, open label clinical study for patients diagnosed with BCG-Unresponsive NMIBC CIS designed in compliance with Health Canada and FDA guidance. The Study Procedure is comprised of the intravesical installation of reconstituted Ruvidar^TM for 1 hour, followed by TLC-3200 intravesical activation for approximately 1 hour.

To date, Theralase® has enrolled and treated 75 patients in Study II, who have been provided the primary Study Procedure by the CSSs.

84% (63/75) of treated patients have completed the clinical study for treatment safety and efficacy according to the clinical study protocol, by being assessed up to 450 days from the date of the Study Procedure or were prematurely removed from Study II.

For the primary endpoint of Study II (Complete Response3 ("CR") at any point in time) 61.9% (39/63) [42.5, 81.3] of patients provided the Study Procedure demonstrated a CR.

Including patients, who demonstrated an Indeterminate Response4 ("IR") to the CR number, the Total Response ("TR") increased to 68.3% (43/63) [47.9, 88.7]. This represents that greater than 2 out of 3 BCG-Unresponsive NMIBC CIS patients treated with Theralase®'s unique Anti-Cancer Therapy ("ACT") demonstrated complete destruction of the cancer in their bladder.

Performance to Primary Objective:

	Primary Endpoint Performance (CR at any Point in Time)
	#	%	Confidence Interval (95%)
Complete Response ("CR")	39	61.9%	[42.5, 81.3]
Total Response (CR and IR)	43	68.3%	[47.9, 88.7]

Performance to Secondary Objective:

For the secondary endpoint of Study II (duration of CR) 43.6% (17/39) [22.9, 64.3] of treated patients who achieved a CR, maintained their CR response for at least 12 months (450 days from date of Study Procedure).

	Secondary Endpoint Performance (Duration of CR) (450 Days)
	#	%	Confidence Interval (95%)
Complete Response ("CR")	17	43.6%	[22.9, 64.3]

Performance to Tertiary Objective:

For the tertiary endpoint of Study II (safety of Study Procedure) 100% (63/63) experienced no Serious Adverse Events ("SAEs") directly related to the Study Drug or Study Device.

	Tertiary Endpoint Performance (Safety) (450 Days)
	#	%
Safety	63	100.0%

In addition, 15.4% (6/17) [3.1, 27.7] of patients who demonstrated a CR at 450 days, continue to demonstrate a CR at 24 months from date of the primary Study Procedure (5 patients are still pending assessment) and 10.3% (4/17) [0.2, 20.4] of patients continue to demonstrate a CR at 36 months from date of the primary Study Procedure (8 patients are still pending assessment).

According to a Kaplan Meier Curve estimate, if CR is obtained, then the patient has a ≥ 53.0% chance of remaining cancer free for 1 year, ≥ 35.8% for 2 years and ≥ 24.9% for 3 years.

The total clinical study sites enrolling patients in North America is now 11 (6 in Canada, 5 in US) with an additional 4 clinical study sites (1 in Canada, 3 in US) scheduled to launch in 4Q2024/1Q2025.

Bobby Shayegan MD, FRCSC, Head - Division of Urology, Chief of Surgery - St. Joseph's Healthcare Hamilton, Director - McMaster Institute of Urology, Associate Professor - Division of Urology, Department of Surgery, McMaster University stated, "I am excited that our hospital network has elected to work with Theralase® in the clinical investigation of their exciting new technology; specifically, light-activated Ruvidar™, for the treatment of patients diagnosed with BCG-Unresponsive NMIBC CIS. Based on the clinical data collected to date, this technology, if approved by Health Canada, represents a great opportunity for patients, who wish to have the opportunity of having their bladder cancer treated effectively, while preserving their quality of life versus undergoing a radical cystectomy (bladder removal surgery). Theralase®'s clinical data has been very impressive, indicating a strong patient efficacy response, duration of that response up to ≥ 3 years and strong safety profile. I look forward to working with Theralase® to launch this clinical study at our location and in the enrollment and treatment of patients."

Dr. Arkady Mandel, M.D., Ph.D., D.Sc., Chief Scientific Officer of Theralase® stated, "I am pleased that St. Joseph's Healthcare Hamilton has agreed to become a clinical study site to participate in this exciting clinical study research. I welcome Dr. Shayegan to the esteemed team of the Study II Principal Investigators, who are currently working to complete this clinical study and help Theralase® prepare for Health Canada and FDA regulatory approval in 2026. Theralase® is focused on expediting the development of the Theralase ® technology, which is showing an opportunity for BCG-Unresponsive NMIBC CIS patients to maintain their quality of life, through retention of their bladders for ≥ 3 years, after a single Study Procedure. Our hope is that the clinical data generated from this study will support the commercialization of Ruvidar, supporting our aim to transform bladder cancer care by delivering technology that significantly improves patient outcomes."

Roger DuMoulin-White, B.E.Sc., P.Eng., Pro.Dir., President and Chief Executive Officer of Theralase® stated, "I am delighted that Dr. Shayegan and his team at St. Joseph's Healthcare Hamilton have agreed to participate in Study II. Theralase® looks forward to working with him and the other principal investigators in Canada and the United States to successfully complete Study II and commercialize this revolutionary technology internationally for the benefit of all patients diagnosed with this disease.As Theralase® completes enrollment in its clinical study, in 2025, Theralase® is actively seeking partnering / licensing opportunities for various geographical territories around the world in the commercialization of Ruvidar™ for the treatment of BCG-Unresponsive NMIBC."

¹ Key Statistics for Bladder Cancer | American Cancer Society (2024)

² Bladder cancer statistics | Canadian Cancer Society (2024)

3 Complete Response ("CR") is defined as negative cystoscopy and negative urine cytology; positive cystoscopy (low grade) and negative cytology or negative cystoscopy and suspicious / positive urine cytology with confirmed upper tract / prostatic urethra disease and negative bladder biopsies

4 Indeterminate Response ("IR") is defined as negative cystoscopy and positive or suspicious urine cytology

About Theralase® Technologies Inc.:

Theralase® is a clinical stage pharmaceutical company dedicated to the research and development of light, radiation, sound and/or drug-activated small molecule 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.sedarplus.ca

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 ("FLS") 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 small molecules and their drug formulations. FLS 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 the Company's management regarding future research, development and commercialization of the Company's small molecules; 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 various clinical studies in a timely fashion and implement its development plans. Other risks include: the ability of the Company to successfully commercialize its small molecule and 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 at all; the risk that the Company's small molecule and 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 terms 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 FLS, which are not a guarantee of future performance. There can be no assurance that FLS will prove to be accurate as such FLS involve known and unknown risks, uncertainties and other factors which may cause actual results or future events to differ materially from the FLS.

Although the FLS 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 FLS.

All FLS 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 FLS.

For investor information on the Company, please feel to reach out Investor Inquiries - Theralase Technologies.

For More Information:
1.866.THE.LASE (843-5273)
416.699.LASE (5273)
www.theralase.com

Kristina Hachey, CPA
Chief Financial Officer X 224
khachey@theralase.com

SOURCE: Theralase Technologies, Inc.

View the original press release on accesswire.com

FAQ

What are the success rates of Theralase's (TLTFF) bladder cancer treatment in Phase II trials?

The Phase II trials showed 61.9% Complete Response rate, increasing to 68.3% with Indeterminate Response. Of those achieving Complete Response, 43.6% maintained it for at least 12 months.

When does Theralase (TLTFF) expect regulatory approval for its bladder cancer treatment?

Theralase is targeting regulatory approval from Health Canada and FDA in 2026.

How many clinical study sites does Theralase (TLTFF) currently operate?

Theralase currently operates 11 clinical study sites in North America (6 in Canada, 5 in US), with 4 additional sites planned for Q4 2024/Q1 2025.