Toronto, Ontario – September 18, 2015, Theralase Technologies Inc. (“Theralase” or the “Company”) (TLT:TSXV) (TLTFF:OTC), a leading biotechnology manufacturer focused on commercializing medical technologies to eliminate pain and destroy cancer, announced today that it has submitted an Investigational Testing Authorization (“ITA”) for its anti-cancer technology to Health Canada for approval. The ITA details information about the proprietary Theralase TLC-3200 Oncology Laser System, which Theralase plans to use to activate the Company’s lead Photo Dynamic Compound (“PDC”), TLD-1433, to destroy Non-Muscle Invasive Bladder Cancer (“NMIBC”). Pending approval of the following applications, Theralase plans to commence enrolling patients inflicted with NMIBC into a Phase Ib clinical study at Princess Margaret Cancer Center, University Health Network (“UHN”) to prove the primary objective of safety and tolerability, with an exploratory objective of efficacy: Health Canada Clinical Trial Application (“CTA”) (Complete); Health Canada ITA (Complete); UHN Research Ethics Board (“REB”). … Read More
Theralase Submits Clinical Trial Application to Health Canada for Approval
Toronto, Ontario – September 17, 2015, Theralase Technologies Inc. (“Theralase” or the “Company”) (TLT:TSXV) (TLTFF:OTC), a leading biotechnology manufacturer focused on commercializing medical technologies to eliminate pain and destroy cancer, announced today that it has submitted a Clinical Trial Application (“CTA”) for its anti-cancer technology to Health Canada for approval. Theralase’s anti-cancer technology utilizes the proprietary Theralase TLC-3200 Oncology Laser System to activate the Company’s lead Photo Dynamic Compound (“PDC”), TLD-1433, to treat Non-Muscle Invasive Bladder Cancer (“NMIBC”). Pending approval of the following applications, Theralase plans to commence enrolling patients inflicted with NMIBC into a Phase Ib clinical study at Princess Margaret Cancer Center, University Health Network (“UHN”) to prove the primary objective of safety and tolerability, with an exploratory objective of efficacy: – UHN Research Ethics Board (“REB”); – Health Canada CTA; – Health Canada Investigational Testing Authorization (“ITA”). Roger Dumoulin-White, President and CEO, Theralase stated, “The submission of … Read More
Theralase Completes Detailed Information on the TLC-3000B Laser System
Toronto, Ontario – September 15, 2015, Theralase Technologies Inc. (“Theralase” or the “Company”) (TLT:TSXV) (TLTFF:OTC), a leading biotechnology manufacturer focused on commercializing medical technologies to eliminate pain and destroy cancer, announced today that it has completed detailed information on how the TLC-3000B Laser System will be used to activate the Company’s 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”) Review Ethics Board (“REB”) approval, expected in late 4Q2015, 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 information pertaining to the laser technology used to activate TLD-1433 marks the fourth and final major milestone for the Company … Read More
Theralase Completes Clinical Protocol
Toronto, Ontario – September 11, 2015, Theralase Technologies Inc. (“Theralase” or the “Company”) (TLT:TSXV) (TLTFF:OTC), 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 … Read More
Theralase Successfully Completes GLP Toxicology Analysis of Lead Drug
Toronto, Ontario – September 10, 2015, Theralase Technologies Inc. (“Theralase” or the “Company”) (TLT:TSXV) (TLTFF:OTC), a leading biotechnology manufacturer focused on commercializing medical technologies to eliminate pain and destroy cancer, announced today that it has successfully completed the toxicology analysis of its lead Photo Dynamic Compound (“PDC”), TLD-1433, in compliance with Good Laboratory Practice (“GLP”) standards. This milestone is critical for a Clinical Trial Application (“CTA”) submission to Health Canada. Pending Health Canada approval of the CTA, Theralase would commence enrolling patients inflicted with Non-Muscle Invasive Bladder Cancer (“NMIBC”) into a Phase Ib clinical trial aimed at proving the primary objective of safety and tolerability with an exploratory objective of efficacy. Completion of the GLP toxicology analysis of TLD-1433 has now achieved the second major milestone for the Company to complete its submission of a CTA application to Health Canada for NMIBC. Key components required to submit a CTA to … Read More
Theralase Research Demonstrates Lead Drug Also Effective for Muscle Invasive Bladder Cancer
Toronto, Ontario – September 9, 2015, Theralase Technologies Inc. (“Theralase” or the “Company”) (TLT:TSXV) (TLTFF:OTC), a leading biotechnology manufacturer focused on commercializing medical technologies to eliminate pain and destroy cancer, announced today that its latest research demonstrates that its lead Photo Dynamic Compound (“PDC”), TLD-1433, in addition to being indicated for the treatment of Non-Muscle Invasive Bladder Cancer (“NMIBC”), may also be effective for the treatment of Muscle Invasive Bladder Cancer (“MIBC”). The latest research involved testing the Photo Dynamic Therapy (“PDT”) of TLD-1433 in an orthotopic rat bladder tumour model. Procedure: – 5 million AY27 rat bladder cancer cells per milliliter were instilled in the sensitized rat bladder for one hour to allow the cancer cells to attach. – Tumours required two to three weeks to grow to an appropriate size – TLD-1433 was intravesically infused into the rat’s bladder at either 0.6 mgmL-1 (representative of human low dose) or 6.0 … Read More
Theralase Completes GMP Manufacture of Lead Drug
Toronto, Ontario – September 8, 2015, Theralase Technologies Inc. (“Theralase” or the “Company”) (TLT:TSXV) (TLTFF:OTC), a leading biotechnology manufacturer focused on commercializing medical technologies to eliminate pain and destroy cancer, announced today that it has completed manufacture of its lead Photo Dynamic Compound (“PDC”), TLD-1433 in compliance with Good Manufacturing Practice (“GMP”) standards. This milestone is critical for a Clinical Trial Application (“CTA”) submission to Health Canada. Pending Health Canada approval of the CTA, Theralase would commence enrolling patients inflicted with Non-Muscle Invasive Bladder Cancer (“NMIBC”) into a Phase Ib clinical trial aimed at proving the primary objective of safety and tolerability with an exploratory objective of efficacy. Completion of the GMP manufacturing of TLD-1433 is a major milestone for the Company and is a prerequisite for a CTA application. Supporting data includes a Chemistry, Manufacturing, and Control (“CMC”) analysis detailing pertinent specifications of the drug. Key components required to … Read More
Theralase Demonstrates Stability of Lead Drug
Toronto, Ontario – September 4, 2015, Theralase Technologies Inc. (“Theralase” or the “Company”) (TLT:TSXV) (TLTFF:OTC), a leading biotechnology manufacturer focused on commercializing medical technologies to eliminate pain and destroy cancer, announced today that it has demonstrated initial stability of its lead Photo Dynamic Compound (“PDC”), TLD-1433, currently being developed by the Company for the treatment of Non-Muscle Invasive Bladder Cancer (“NMIBC”). Demonstrating long term and accelerated stability of a drug to be used in human clinical testing is essential to prove that the potency and/or efficacy of the drug is not affected during prolonged shelf life. Under long term and accelerated stability storage conditions, the drug is evaluated by High Performance Liquid Chromatography (“HPLC”) to separate, identify and quantify each chemical component to a very high degree of resolution to assess if any changes occur in the chemical composition over time. Long term stability is completed over three years, with … Read More
Theralase Expands Photo Dynamic Compound Pipeline
Toronto, Ontario – September 3, 2015, Theralase Technologies Inc. (“Theralase” or the “Company”) (TLT:TSXV) (TLTFF:OTC), a leading biotechnology manufacturer focused on commercializing medical technologies to eliminate pain and destroy cancer, announced today that it has expanded its Photo Dynamic Compound (“PDC”) pipeline by demonstrating the efficacy of its Osmium based PDC platform. The latest research has been selected for presentation at the 28th Annual International Congress on Laser Medicine and Surgery scheduled from November 5 to 7, 2015 in Florence, Italy. The abstract will publish in the peer-reviewed journal “Laser in Medical Science” with the complete paper to publish in the peer-reviewed journal “Laser Therapy”. The International Congress on Laser Medicine and Surgery focuses on translating the latest research from the laboratory bench to the bedside in the field of medical laser technology. The year 2015 has also been declared “Year of the Light” by the United Nations Educational, Scientific … Read More
Theralase Releases 2Q2015 Financials
Toronto, Ontario – August 28, 2015, Theralase Technologies Inc. (“Theralase” or the “Company”) (TLT:TSXV) (TLTFF:OTC), a leading biotechnology manufacturer focused on commercializing medical technologies to eliminate pain and destroy cancer, released its second quarter 2015 financial results today. Revenue for the six-month period ended June 30, 2015 decreased by 21% from the same period in 2014. In Canada, revenue increased 11% to $562,890 from $508,523, while US revenue decreased 54% from $215,107 to $99,343 and international revenue decreased 89% from $136,807 to $15,584. The moderate increase in Canadian revenue and the corresponding decrease in US and international revenue is attributable to the Company’s mandate of realigning its sales and marketing team for the anticipated launch of the next generation therapeutic laser system, starting in Canada, in 4Q2015. Once launched in Canada, the Company will focus on building out its sales and marketing team first in the US and then internationally, … Read More