Theralase Technologies (
TSX: V.TLT,
Stock Forum) made significant headway in bringing its lead anti-cancer drug to market when the company announced today that it had manufactured its first pre-commercial batch of Photo Dynamic Compound (“PDC”), TLD-1433.
According to the
news release, Good Manufacturing Practices (“GMP”) must be followed when producing drugs intended for use in humans and as a result, said drugs have to go through a “scale up” process in production from a small quantity to validate manufacturing process to larger pre-commercial quantities produced under the GMP standards for human use.
The company has achieved pre-commercial production status and will be releasing the production lot to Health Canada for toxicology testing, a key component to Health Canada Clinical Trial Application (“CTA”).
A second pre-commercial batch is scheduled to be produced in Q2 2015 to continue optimizing the manufacturing process and provide research materials for testing of additional cancer indications of TLD-1433. Production of a commercial batch adhering to human use GMP standards is expected to be complete in Q2 2015.
Company Chief Scientific Officer, Dr. Arkady Mandel, commented, “We have been successful in establishing a robust scale-up manufacturing process for our anti-cancer drugs. We have managed to transfer the manufacturing process knowledge of TLD-1433 from the laboratory to pre-commercial production levels, able to fulfill requirements to initiate the toxicology program. It has been demonstrated repeatedly that our lead PDC is effective in the treatment of cancer in animal models and we look forward to effectively treating cancer in humans in a clinical setting.”
He explained, “The successful production of the first pre-commercial batch of our lead PDC, TLD-1433, represents one of the most important milestones to date in the history of Theralase's anti-cancer program, leading to commercial production of advanced biopharmaceuticals for the treatment of cancer.”
Roger Dumoulin-White, President and CEO of Theralase, added, “Theralase is extremely well positioned to commence our Health Canada Phase Ib human clinical studies in bladder cancer in 4Q2015, now that we have successfully assembled a top notch team consisting of: cutting-edge research scientists, world renowned uro-oncologists, world-class manufacturing, an internationally recognized toxicology lab and a strong clinical research organization. 2015 will be a landmark year for the Company, as we execute on our strategic initiatives.”
Theralase Technologies was in the news recently when
the Toronto-based company announced holding a pre-CTA meeting with Health Canada a week ago.
Shares gained 3.03% on the news to $0.34 per share.
Currently there are 104.6m outstanding shares with a market cap of $35.6 million.