Theralase Technologies (TLT-V) May 12, '15 leading biotechnology manufacturer focused on commercializing medical technologies to eliminate pain and destroy cancer, announced today that it has successfully manufactured its lead, light-activated, anti-cancer drug, TLD-1433, specifically developed for the treatment of cancer, to high purity levels.
Drugs intended for in human clinical applications, such as TLD-1433, must be manufactured in accordance with Good Manufacturing Practices (“GMP”) standards. To achieve GMP standards, the normal manufacturing process involves “scaling-up” the production from small quantities to successively larger quantities to optimize the purity and yield of the drug to arrive at a commercial grade product, suitable for human applications.
In April 2015, Theralase announced the completion of the manufacture of its lead anti-cancer drug in pre-commercial quantities. The Company has now completed another critical step, optimization of the manufacturing process to produce high purity TLD-1433. This latest high purity batch will be used to complete the Good Laboratory Practices (“GLP”) toxicology analyses, a key component of the Clinical Trial Application (“CTA”) that the Company plans to file with Health Canada (“HC”) in 3Q2015. The Company can now focus on completion of the final and most important step, manufacture of a GMP batch of TLD-1433 suitable for use in human clinical applications. Pending HC approval of the CTA, the Company plans to enroll patients in a Phase Ib clinical study for Non Muscle Invasive Bladder Cancer (“NMIBC”) to prove the safety, tolerability and efficacy of its anti-cancer technology in a human population in 4Q2014.
Production of a GMP batch of TLD-1433 provides enough anti-cancer drug to support Theralase’s entire clinical program through to commercialization in the treatment of patients with NMIBC, while also providing sufficient PDC for the Company to further investigate other cancer indications.
Dr. Arkady Mandel, Chief Scientific Officer stated that, “We have previously demonstrated success in establishing a robust scale-up manufacturing process for our lead anti-cancer drug. We have now demonstrated success in optimizing the manufacturing and purification processes to produce not only a very pure drug, but also a drug that can be reliably manufactured to high purity levels to deliver consistent clinical safety and efficacy outcomes. Our lead PDC has repeatedly demonstrated that it is effective in the treatment of cancerous tumours in animal models and we will soon have the opportunity to demonstrate this same success in humans. The production of a high purity batch of our lead drug candidate represents our ongoing commitment of bringing new medical technology to market with high benefits for the patients who suffer from this deadly disease.”
Roger Dumoulin-White, President and CEO stated, “Theralase continues to make significant leaps forward in our anti-cancer technology program. Theralase is on track to complete the final steps required to submit a CTA to HC in 3Q22014; specifically: GMP manufacture of our lead anti-cancer drug, completion of GLP toxicology drug analyses and finalization of the clinical protocol detailing how to treat patients inflicted with NMIBC. Pending HC approval, the Company will enroll patients in a Phase Ib human clinical study for NMIBC in 4Q2015. 2015 will be an inflection point in the performance of the Company, as we execute on these strategic initiatives.”
About Theralase Technologies Inc.
Theralase Technologies Inc. (“Theralase®”) (TSXV: TLT) (TLTFF: OTC Pink®) in its Therapeutic Laser Technology (“TLT”) 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 (“PDT”) Division researches and develops specially designed molecules called Photo Dynamic Compounds (“PDCs”), which are able to localize to the cancer cells and then when laser light activated, effectively destroy them.
Additional information is available at www.theralase.com and www.sedar.com .
For More Information:
Roger Dumoulin-White
President & CEO, Theralase Technologies Inc.
1.866.THE.LASE (843-5273) ext. 225
416.699.LASE (5273) ext. 225
rwhite@theralase.com
www.theralase.com
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public://news_release_pdf/theralase05122015.pdf
Source: Theralase Technologies Inc. (TSX Venture:TLT) theralase.com / |
