Theralase(R) Commences GLP Toxicology Analysis of Rutherrin(R)
Theralase begins GLP toxicology work on intravenous Rutherrin, aiming to enable first-in-human trials across several aggressive cancer indications.
Rhea-AI Summary
Theralase (TLTFF) has commenced Good Laboratory Practice (GLP) toxicology analysis of intravenously administered Rutherrin, its patented Ruvidar–transferrin cancer therapeutic.
The GLP program is designed to determine the optimum intravenous dose to support first-in-human clinical studies for glioblastoma multiforme (GBM), non-small cell lung cancer (NSCLC) and muscle-invasive bladder cancer (MIBC), with pancreatic and colorectal cancers to be investigated as the program advances. Completion of the GLP toxicology analysis is expected in 2026, with results anticipated in early 2027. The company states that, if successful, the data could enable an adaptive clinical development program, broader clinical indications and potential future partnerships or licensing opportunities.
Positive
- GLP toxicology program for intravenous Rutherrin has formally commenced
- Study aims to establish optimum dose for first-in-human trials in GBM, NSCLC and MIBC
- GLP toxicology completion targeted for 2026 with results expected in early 2027
- Company cites potential for broader clinical program and future partnerships if results are successful
Negative
- GLP toxicology results not expected until early 2027, implying a multi-year path before potential first-in-human trials
AI-generated analysis. How Rhea-AI works. Not financial advice.
Successful completion of GLP toxicology analysis for the intravenous administration of Rutherrin(R) lays the groundwork for regulatory submissions supporting first-in-human clinical development for multiple life-threatening cancers
Toronto, Ontario--(Newsfile Corp. - September 15, 2026) - Theralase® Technologies Inc. (TSXV: TLT) (OTCQB: TLTFF) ("Theralase®" or the "Company"), a clinical-stage pharmaceutical company dedicated to the research and development of energy-activated small molecules for the safe and effective destruction of various cancers, bacteria and viruses, is pleased to announce that Good Laboratory Practice ("GLP") toxicology analysis of intravenously administered Rutherrin® has commenced.
Rutherrin® is formed by combining Theralase®'s lead small molecule Ruvidar® with transferrin (blood plasma protein made by the liver that transports iron throughout the body). Rutherrin® has demonstrated preclinically the ability to target cancer cells and after energy-activation destroy the target cancer cell.
The GLP toxicology analysis of Rutherrin® represents an important step forward for regulatory submissions in the clinical development of Rutherrin®. The program has been designed to generate GLP data of intravenous administration of Rutherrin® to determine the optimum dose for first-in-human clinical studies for Glio Blastoma multiforme ("GBM") (a deadly form of brain cancer), Non-Small Cell Lung Cancer ("NSCLC") (the second most common cancer and the leading cause of cancer death globally) and Muscle-Invasive Bladder Cancer ("MIBC") (
Upon receipt of GLP toxicology reports and regulatory approval, the Company plans to commence an adaptive clinical development program of intravenous Rutherrin® for various life-threatening cancers.
The adaptive clinical development program is designed to evaluate the quantity of Rutherrin® localized within various cancerous tumours following a single intravenous administration. If proven successful, multiple intravenous administrations of energy-activated Rutherrin® will be evaluated for safety, tolerability and efficacy for various oncological conditions, in combination with (or without) other standards of care.
The GLP toxicology analysis is expected to be completed in 2026, with the results expected to be available in early 2027.
Theralase® has previously reported preclinical research supporting the safety and efficacy of energy-activated Rutherrin® in multiple life-threatening cancers.
When successfully completed, the GLP toxicology program could lead to a broader clinical development program and create opportunities for future pharmaceutical partnerships, licensing arrangements and combination-treatment studies.
Arkady Mandel, MD, PhD, DSc, Chief Scientific Officer of Theralase® stated, "Our scientific team has generated an extensive body of preclinical research demonstrating Rutherrin®'s potential across numerous life-threatening cancers. I am delighted that after years of research Theralase® is now in the position to commence GLP toxicology analysis for the intravenous administration of Rutherrin®. Pending successful completion of this analysis, the Company is laser-focused on the clinical development of this technology for: GBM, NSCLC, MIBC and many other deadly and/or hard-to-treat cancers."
About Rutherrin®
Rutherrin® is Theralase®'s patented formulation of Ruvidar®, which when combined with recombinant human transferrin, can be used for intravenous administration. The transferrin component has been designed to transport the payload Ruvidar® and facilitate the preferential uptake and retention of it within cancer cells prior to energy-activation.
About Theralase® Technologies Inc.
Theralase® is a clinical-stage pharmaceutical company dedicated to the research and development of energy-activated small molecules for the safe and effective destruction of cancer, 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 and forward-looking information (collectively, "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 energy-activated 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 energy-activated 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 regulatory approvals to successfully complete various clinical studies in a timely fashion and implement its commercial development plans. Other risks to the Company include: successful commercialization of its energy-activated small molecules and drug formulations; access to sufficient capital to fund the Company's operations on terms that are commercially favorable to the Company or at all; the safety and effectiveness of the Company's energy-activated small molecules and formulations against the diseases tested in its clinical studies; the failure to comply with the terms of license agreements with third parties and as a result lose the right to use key intellectual property in its business; the 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
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/314313
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
Which cancer indications are initially targeted in the Rutherrin GLP toxicology program?
The GLP toxicology program is designed to support first-in-human studies for glioblastoma multiforme (GBM), non-small cell lung cancer (NSCLC) and muscle-invasive bladder cancer (MIBC). The company also plans to investigate additional cancers, including pancreatic and colorectal cancer, as the clinical program progresses and data are analyzed.
What is the intended design of the planned clinical development program for Rutherrin?
The company plans an adaptive clinical development program of intravenous Rutherrin. It is designed first to evaluate how much Rutherrin localizes within various tumours after a single intravenous dose. If this is successful, multiple intravenous administrations of energy-activated Rutherrin will be evaluated for safety, tolerability and efficacy in various oncological conditions, with or without other standards of care.
How is Rutherrin formulated and how is it intended to work?
Rutherrin is a patented formulation in which Theralase’s lead small molecule Ruvidar is combined with recombinant human transferrin for intravenous administration. The transferrin component is designed to transport Ruvidar and facilitate its preferential uptake and retention within cancer cells before energy-activation, after which energy-activated Rutherrin has demonstrated preclinical cancer cell destruction.