Theralase(R) Launches Three New Clinical Study Sites in USA

Rhea-AI Summary

Theralase Technologies has launched three new US-based Clinical Study Sites for its bladder cancer registrational clinical study. The sites include Associated Medical Professionals of NY, Urology of Indiana, and Central Ohio Urology Group. The company's Phase II registration study for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer has enrolled and treated 75 patients to date.

Key clinical results show that 61.9% of patients demonstrated a Complete Response, with Total Response reaching 68.3%. For duration of response, 43.6% of treated patients maintained Complete Response for at least 12 months. The safety profile shows 100% of patients experienced no Serious Adverse Events related to the treatment. According to Kaplan Meier estimates, patients achieving Complete Response have a ≥53.0% chance of remaining cancer-free for 1 year, ≥35.8% for 2 years, and ≥24.9% for 3 years.

Positive

• 61.9% of patients showed Complete Response with Total Response reaching 68.3%
• 43.6% of treated patients maintained Complete Response for 12+ months
• 100% safety profile with no Serious Adverse Events
• Expansion to three new US clinical sites, bringing total to 14 in North America
• 15.4% of Complete Response patients maintain cancer-free status at 24 months

Negative

• Still in clinical trial phase, pending regulatory approval
• Response rates decline over time (53% at 1 year to 24.9% at 3 years)
• Commercialization not expected until 2026

Associated Medical Professionals of NY, Urology of Indiana and Central Ohio Urology Group are the latest three US-based study sites for clinical research of Theralase®'s bladder cancer treatment

TORONTO, ON / ACCESSWIRE / December 9, 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 three new US-based Clinical Study Sites ("CSSs") for its bladder cancer registrational clinical study; specifically: Associated Medical Professionals of NY (Syracuse, New York), Urology of Indiana (Greenwood, Indiana) and Central Ohio Urology Group (Gahanna, Ohio).

The Principal Investigators ("PIs") for the Theralase® clinical study at the new CSSs are as follows:

Associated Medical Professionals of NY - Ilija Aleksic, MD

Dr. Aleksic graduated summa cum laude from the University at Buffalo and went on to complete medical school at SUNY Upstate Medical University. Dr. Aleksic received his urological surgery training at Albany Medical Center and was a chief resident in 2019. He has also participated in patient advocacy meetings with local and national elected officials. He has published numerous basic science and clinical research with a focus on men's health. He has presented his work at national and international meetings and has won numerous awards.

Urology of Indiana - Eugene Cone, MD

Dr. Cone graduated from Harvard University with High Honors in Biology. He earned an academic scholarship to the Alpert School of Medicine at Brown University, where he obtained his medical degree. He completed his internship in General Surgery and his residency in Urologic Surgery from Duke University in Durham, North Carolina. He then completed a two-year fellowship in urologic oncology in Boston at Massachusetts General Hospital, Brigham and Women's Hospital and Dana Farber Cancer Center.

Central Ohio Urology Group - Benjamin Martin, MD

Dr. Martin is a urologist in Gahanna, Ohio and is affiliated with multiple hospitals in the area, including OhioHealth Grant Medical Center and Mount Carmel St. Ann's Hospital. He received his medical degree from Ohio State University College of Medicine and has been in practice for more than 20 years.

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 14 (6 in Canada, 8 in US) with an additional CSS scheduled to launch in 1Q2025.

Christopher Pieczonka, MD, Chief Executive Officer of Associated Medical Professionals of NY, stated, "Our clinical team isextremely interested in the clinical investigation of Theralase®'s drug-device 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 the FDA, represents a great alternative for patients who wish to have the opportunity of having their bladder cancer treated safely and effectively, while preserving their quality of life, versus undergoing a radical cystectomy (bladder removal surgery). I am impressed by Theralase®'s clinical data, which has demonstrated a strong patient efficacy response, duration of that response up to ≥ 3 years with a single treatment and a strong safety profile. I look forward to working with Theralase® and our clinicians to launch this clinical study at our various locations and in the enrollment and treatment of patients."

Arkady Mandel, M.D., Ph.D., D.Sc., Chief Scientific Officer of Theralase® stated, "I am pleased that Associated Medical Professionals of NY, Urology of Indiana and Central Ohio Urology Group have agreed to become clinical study sites to participate in this exciting clinical study research. I welcome Dr. Aleksic, Dr. Cone and Dr. Martin 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 and our mandate of optimizing bladder cancer care by delivering state-of-the-art 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. Aleksic, Dr. Cone and Dr. Martin and their respective teams at Associated Medical Professionals of NY, Urology of Indiana and Central Ohio Urology Group have agreed to participate in Study II. Theralase® looks forward to working with them 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."

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

²Bladder 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 urine cytology, without confirmatory negative bladder biopsies

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 latest clinical trial results for Theralase (TLTFF) bladder cancer treatment?

The Phase II trial shows 61.9% of patients achieved Complete Response, with 43.6% maintaining response for 12+ months. The treatment demonstrated 100% safety with no serious adverse events.

How many clinical study sites does Theralase (TLTFF) now have for its bladder cancer treatment?

Theralase now has 14 clinical study sites in North America (6 in Canada, 8 in US), with three new US sites recently added and another scheduled for Q1 2025.

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

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

What is the long-term efficacy of Theralase's (TLTFF) bladder cancer treatment?

Patients achieving Complete Response have a ≥53.0% chance of remaining cancer-free for 1 year, ≥35.8% for 2 years, and ≥24.9% for 3 years.