For health and drug regulatory agencies, medication must not only be produced according to regulation standards, but manufacturers must prove that each production will have the same potency and yield as the original batch. Theralase Technologies (TLT:CA) , manufacturer and marketer of a patented super-pulsed laser technology used to eliminate pain, reduce inflammation and accelerate tissue healing, has made a significant breakthrough that furthers the company’s mission to treat the deadly disease.
The Toronto-based company has announced that its lead Photo Dynamic Compound (“PDC”), TLD-1433, is in compliance with Good Manufacturing Practice (“GMP”) standards and has completed manufacturing of a second batch. In late 4Q 2015, Theralase will conduct a Phase Ib clinical trial in order to evaluate the safety and tolerability of TLD-1433.
“Theralase continues to execute on its strategic initiative to advance its anti-cancer technology to commence destroying NMIBC this year,” said Roger Dumoulin-White, President and CEO of Theralase. “Theralase has now demonstrated control of its manufacturing process to produce high grade TLD-1433 in large quantities. Pending successful completion of a Phase Ib and Phase II clinical study in NMIBC, Theralase now possesses the ability to rapidly ramp up production of TLD-1433 in commercial quantities to supply oncology institutions, who treat this deadly disease.”
Major Development in the Fight Against Cancer
This announcement follows a number of positive updates from the company. This past September, Theralase completed a detailed report of how its TLC-3000B Laser System will be used to treat Non-Muscle Invasive Bladder Cancer (NMIBC). Furthermore, Theralase’s anti-cancer technology, where its TLC-3200 Oncology Laser System is used in conjunction with the PDC, TLD-1433, was submitted to Health Canada for clinical trial approval.
Each year in the United States, 50,000 men and 16,000 women are diagnosed with bladder cancer. This development is a major milestone for Theralase, as well as a significant development in the fight against cancer. Their innovative technologies and successful drug manufacturing trials are bringing medicine one step closer to effectively treating NMIBC.
Equities.com had the opportunity to interview Michael Borovec, Director of Investor Relations at Theralase. The interview can be readhere. For more information about Theralase Technologies, visit www.theralase.com.
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