Theralase Demonstrates Stability of Lead Drug
September 4, 2015 (Source: Accesswire) — Theralase Technologies Inc. (“Theralase” or the “Company”) (TSXV: TLT) (PINKSHEETS: TLTFF), 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 reporting at 0, 3, 6, 9, 12, 18, 24 and 36 months. Accelerated stability is completed over six months, with reporting at 0, 3 and 6 months.
The data collected at three months represent the first reporting period under long term stability and the mid-way point under accelerated stability. TLD-1433 has clearly demonstrated that it has remained stable at these reported time periods. According to Health Canada guidelines, long term and accelerated stability must be demonstrated at 6 months to commence treating patients in a clinical study.
Roger Dumoulin-White, President and CEO, Theralase stated that, “Theralase has shown that TLD-1433, being developed for NMIBC, has passed another hurdle on its way to being evaluated clinically. The Company is confident that TLD-1433 will remain stable over the next 3 months, allowing Theralase the opportunity to get one step closer to proving its primary objective of safety and tolerability, and an exploratory objective of efficacy, in cancer patients afflicted with NMIBC, in a Phase Ib human trial scheduled to commence in late 4Q2015.”
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About Theralase Technologies Inc.
Theralase Technologies Inc. (“Theralase(R)”) (TSXV: TLT) (OTC: TLTFF) 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.
Raj Shah has professional experience working for over a half a dozen years at financial firms such as Merrill Lynch and First Allied Securities Inc., ... <Read more about Raj Shah>