Theralase progresses to high purity anti-cancer drug: poised for human trials.
Those who signed up for Theralase Technologies Inc.’s (TSXV: TLT | OTCBB: TLTFF), news alert woke up to a pleasant surprise on May 12 as it reported successful manufacturing of its light-activated anti-cancer drug, TLD-1433 to high purity levels sufficient to enter Good Manufacturing Practices (GMP), review by regulators.
Pending Health Canada’s approval, the Company is ready to proceed to manufacturing a GMP batch of TLD-1433 suitable for use in human clinical applications and finalizing a clinical protocol detailing how to treat patients suffering from Non Muscle Invasive Bladder Cancer (NMIBC).
This represents a critical milestone for Theralase’s TLD-1433, which was demonstrated to induce resistance to cancer in mice using its proprietary Photo Dynamic Therapy (PDT), TLDOsH2IP molecule.
TLD-1433’s anti-cancer potential is light-activated and the object of a US patent application titled “Transferrin Enhanced Photo Dynamic Therapy (PTD), Cancer Destruction” reported in January 2015 (http://theralase.com/pressrelease/theralase-files-us-patent-application-increased-targeting-photo-dynamic-therapy/).
The human body naturally produces transferrin, an iron-binding blood plasma glycoprotein. Theralase’s TLD-1433 is administered and then binds with transferrin to form Rutherrin. The recently branded and trademarked Rutherrin complex is then absorbed into a cancer cell’s cytoplasm. Then, the cancer cell’s death is triggered by apoptosis (natural cell death) through light activation.
The destruction of cancer cells through apoptosis is safe, effective and provokes virtually no side effects. As if this ability to eradicate cancer cells were not enough, Rutherrin may also be used as a tool to detect cancer cells through fluorescence, a much faster and easier tool for an oncologist to use. Fluorescent micrographic images of rat cancer cells were found to be greatly visible by the introduction of transferrin. Roger Dumoulin-White, President and CEO of Theralase has hailed this newly developed ability to enter, locate, attach to, and destroy cancer cells a “clear first mover advantage in the war on cancer“.
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Regulators demand stringent production standards before allowing clinical research. Among such standards, drugs must be manufactured in accordance with GMP standards to ensure purity and safety.
Theralase has now achieved this critical standard for their anti-cancer drug and will be using their latest high purity batch to complete analyses. This represents the final and essential step of their Clinical Trial Application that will be submitted to Health Canada.
To achieve GMP standards, the normal manufacturing process scales up production from small quantities to successively larger quantities. The purity and yield of the drug produced is thus optimized and is considered a commercial grade product, suitable for human applications.
Theralase Technologies is a cutting-edge company that has potentially pioneered the first effective and safe cancer cell detection and destruction tool. Theralase also investigates and develops the use of super-pulsed, cold laser technology for a wide range of human, companion animal and equine applications.
Their anti-cancer technology is divided into two distinct sectors: Therapeutic Laser Technology and Photo Dynamic Therapy. The former focuses on the development and commercialization of FDA, Health Canada and CE approved laser-based biomodulation (which is a therapeutic, non-invasive laser technology that targets tissue inflammations, degeneration and other pains), whilst the latter develops advanced pharmaceutical products and medical devices targeting oncology markets. The TLD-1433 anti-cancer drug falls into the latter category.
Dr. Luc C. Duchesne is a Speaker and Author with a PhD in Biochemistry. With three decades of scientific and business experience, he has published ... <Read more about Dr. Luc Duchesne>