Theralase Completes Clinical Protocol
September 11, 2015 (Source: Accesswire) — Theralase Technologies Inc. (“Theralase” or the “Company”) (TSX Venture:TLT) (PINKSHEETS:TLTFF), a leading biotechnology manufacturer focused on commercializing medical technologies to eliminate pain and destroy cancer, announced today that it has completed the Clinical Protocol and Investigator’s Brochure detailing the application of its lead light activated Photo Dynamic Compound (“PDC“), TLD-1433 in the treatment of Non-Muscle Invasive Bladder Cancer (“NMIBC“).
Pending Health Canada approval of a Clinical Trial Application (“CTA“) and Princess Margaret Cancer Center, University Health Network (“UHN“) Research Ethics Board (“REB“) approval, Theralase plans to commence enrolling patients inflicted with NMIBC into a Phase Ib clinical study at UHN to prove the primary objective of safety and tolerability, with an exploratory objective of efficacy.
Completion of the Clinical Protocol and Investigator’s Brochure marks the third major milestone for the Company to complete its submission of a CTA application to Health Canada.
Key components required to submit a CTA to Health Canada for a new drug / device combination include:
1) GMP manufacture of the drug (Complete);
2) Good Laboratory Practice toxicology analysis of the drug (Complete);
3) Completion of the Clinical Protocol and Investigator’s Brochure (Complete);
4) Completion of detailed information regarding the device used to activate the drug.
The Clinical Protocol and Investigator’s Brochure details the Standard Operating Procedures (“SOP’s“) that a uro-oncologist must follow to administer a Photo Dynamic Therapy (“PDT“) treatment using TLD-1433 to a patient inflicted with NMIBC.
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Michael Jewett, MD, a Professor of Surgery in the Division of Urology at the University of Toronto, a member of the Department of Surgical Oncology at Princess Margaret Cancer Centre and of the Division of Urology at UHN stated that, “The UHN clinical team and myself have worked hand in hand with Theralase and their clinical regulatory consultants over the summer to complete the Clinical Protocol and Investigator’s Brochure detailing the SOPs for the administration of TLD-1433 to patients presenting with NMIBC. In my review, Theralase is now one step away from submitting both a CTA to Health Canada and a REB to UHN. Pending approval of these two submissions, Theralase will commence enrolling patients for treatment in a Phase Ib clinical study for NMIBC at UHN.”
About Theralase Technologies Inc.
Theralase Technologies Inc. (“Theralase(R)“) (TSXV: TLT) (TLTFF: OTC) in its Therapeutic Laser Technology Division designs, manufactures and markets patented super-pulsed laser technology indicated for the: elimination of pain, reduction of inflammation and dramatic acceleration of tissue healing for numerous nerve, muscle and joint conditions. Theralase’s Photo Dynamic Therapy Division researches and develops specially designed molecules called Photo Dynamic Compounds, which are able to localize to cancer cells and then when laser light activated, effectively destroy them.
Theralase Technologies Inc. was recognized as a TSX Venture 50(R) company in 2015. TSX Venture 50 is a trademark of TSX Inc. and is used under license.
This press release contains forward-looking statements, which reflect the Company’s current expectations regarding future events. The forward-looking statements involve risks and uncertainties. Actual results could differ materially from those projected herein. The Company disclaims any obligation to update these forward-looking statements.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchanges) accepts responsibility for the adequacy or accuracy of this release.
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