Therlase manufactures high purity anti cancer drug meeting GMP standards
Theralase technologies inc. has successfully manufactured GMP grade lead, light activated, anti cancer drug, TLD-1433, specifically developed for the treatment of cancer. 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 2015. 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.
Theralases Photo Dynamic Therapy (PDT) Division researched and developed 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. 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 Photo Dynamic Compounds (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.