Theralase Demonstrates 24 Month Stability of Lead Anti-Cancer Drug
Toronto, Ontario – September 18, 2017
Theralase Technologies Inc. (“Theralase®” or the “Company”) (TSXV: TLT) (OTCQX: TLTFF), a leading biotech company focused on the commercialization of medical devices to eliminate pain and the development of Photo Dynamic Compounds (“PDCs”) to destroy cancer, announced today that it has demonstrated 24 months long term stability of it lead anti-cancer PDC, TLD-1433.
Stability studies are an essential component of pharmaceutical development, allowing evaluation of a drug’s stability under the influence of a variety of environmental factors such as: temperature, humidity and light. Data from these studies enable recommended storage conditions, retest intervals and shelf lives to be established.
Demonstrating long term 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.
TLD-1433, in the most recent testing report, demonstrated that its purity has changed less than 1.7% in 24 months of long term stability testing, indicating extreme stability of the compound.
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 change occurs 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.
6 months accelerated stability and 24 months long term stability testing have now been successfully completed.
The next long term stability reporting period will be at 36 months.
TLD-1433 has demonstrated that it has remained stable at these reported time periods and according to Health Canada guidelines, accelerated and long term stability has now been proven at 6 months and 24 months, respectively, allowing use in treating patients in a clinical study.
Theralase is currently focused on enrolling and treating the last 5 patients in a Phase Ib clinical trial for patients afflicted with Non-Muscle Invasive Bladder Cancer (“NMIBC”) utilizing its novel, next generation light-activated, anti-cancer drug, TLD-1433.
The Phase Ib NMIBC clinical trial will evaluate TLD-1433 for the primary endpoints of safety and tolerability, with a secondary endpoint of pharmacokinetics (movement and exit of drug within tissue) and an exploratory endpoint of efficacy.
About Theralase Technologies Inc.
Theralase Technologies Inc. (“Theralase®” or the “Corporation”) (TSXV: TLT) (OTCQX: TLTFF) in its Therapeutic Laser Technology (“TLT”) Division designs, manufactures, markets and distributes patented super-pulsed laser technology indicated for the treatment of chronic knee pain, and in off-label use, 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 (“PDT”) Division researches and develops specially designed molecules called Photo Dynamic Compounds (“PDCs”), which localize to cancer cells and then when laser light activated, effectively destroy them.
This news release contains “forward-looking statements” which reflect the current expectations of management of the Corporation’s future growth, results of operations, performance and business prospects and opportunities. Such statements include, but are not limited to, statements regarding the proposed use of proceeds. Wherever possible, words such as “may“, “would“, “could“, “should”, “will“, “anticipate“, “believe“, “plan“, “expect“, “intend“, “estimate“, “potential for” and similar expressions have been used to identify these forward-looking statements. These statements reflect management’s current beliefs with respect to future events and are based on information currently available to management. Forward-looking statements involve significant risks, uncertainties and assumptions. Many factors could cause the Corporation’s actual results, performance or achievements to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements; including, without limitation, those listed in the filings made by the Corporation with the Canadian securities regulatory authorities (which may be viewed at www.sedar.com). Should one or more of these risks or uncertainties materialize, or should assumptions underlying the forward looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully and prospective investors should not place undue reliance on the forward-looking statements. Although the forward-looking statements contained in the news release are based upon what management currently believes to be reasonable assumptions, the Corporation cannot assure prospective investors that actual results, performance or achievements will be consistent with these forward-looking statements. The Corporation disclaims any intention or obligation to revise forward-looking statements whether as a result of new information, future developments or otherwise except as required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.
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.
For More Information:
President & CEO
1.866.THE.LASE (843-5273) ext. 225
416.699.LASE (5273) ext. 225