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Theralase Technologies Inc.
Theralase Demonstrates 36 Months Stability of Lead Anti-Cancer Drug
Published Jun 6 2018
5 min read

Theralase Demonstrates 36 Months Stability of Lead Anti-Cancer Drug

Theralase Demonstrates 36 Months Stability of Lead Anti-Cancer Drug




Theralase Demonstrates 36 Months Stability of Lead Anti-Cancer Drug



Toronto, Ontario (FSCwire) - Theralase Technologies Inc. (“Theralase®” or the “Company”) (TSXV: TLT) (OTCQX: TLTFF), a clinical stage pharmaceutical company dedicated to the research and development of light activated Photo Dynamic Compounds (“PDCs”) and their associated drug formulations intended to safely and effectively destroy cancer has announced today that it has demonstrated 36 months long term stability of the clinical batch of its lead anti-cancer PDC, TLD-1433.

 

The confirmation of 36 months long term stability of TLD-1433 ensures that sufficient amounts of the PDC will be available at Good Manufacturing Practice (“GMP”) levels for multiple Photo Dynamic Therapy (“PDT”) patient treatments during the planned Phase 2 clinical study for Non-Muscle Invasive Bladder Cancer (“NMIBC”).

 

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 life 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.

 

The clinical batch of TLD-1433, in the most recent testing report, demonstrated that its purity has been virtually unchanged over 9, 12, 18, 24 and 36 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.

 

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 36 months, respectively, allowing use in treating patients in a clinical study.

 

As previously announced, Theralase has successfully completed a Phase Ib NMIBC clinical trial for TLD-1433 for the primary endpoints of safety and tolerability and secondary endpoint of pharmacokinetics (movement and exit of drug within tissue) and looks forward to commencing a multi-center Phase II NMIBC clinical study.

 

About Theralase Technologies Inc.

 

Theralase® is a clinical stage pharmaceutical company dedicated to the research and development of light activated Photo Dynamic Compounds and their associated drug formulations intended to safely and effectively destroy cancer.  The Company in its Cool Laser Division designs, manufactures and distributes patented and proprietary super-pulsed cool laser technology for the treatment of knee pain, and in off-label use, the treatment of numerous nerve, muscle and joint conditions.

 

Additional information is available at www.theralase.com and www.sedar.com.

 

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 Theralase’s proposed development plans with respect to Photo Dynamic Compounds and their drug formulations. 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 including with respect to the ability of Theralase to: secure the requisite regulatory approvals to commence, to  fund and to successfully complete a multi-center Phase II NMIBC clinical study and implement its development plans. 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 press 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:

1.866.THE.LASE (843-5273)

416.699.LASE (5273)

info@theralase.com

www.theralase.com







Source: Theralase Technologies Inc. (TSX Venture:TLT, OTCQX:TLTFF, FWB:TTX)

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