Theralase Technologies (TLT-V) Oct 7, '14 has collaborated with Sigma-Aldrich Corp.'s custom manufacturing services business unit, SAFC Commercial, in the manufacture of the photodynamic compounds being developed by Theralase for the destruction of cancer.
Under the terms of the agreement, SAFC will develop the standard operating procedures to manufacture initial quantities of each of Theralase's four lead photodynamic compounds. Once Theralase selects the final lead PDC at the end of the fourth quarter 2014, SAFC will manufacture both a 100-gram pregood-manufacturing-practice batch and finally a 500-gram GMP batch of the PDC. This final 500-gram batch is intended to be suitable for final sterilization and packaging into individual patient doses for safety and efficacy evaluation through a Health Canada/Food and Drug Administration phase I/IIa clinical trial, expected in early 2015.
SAFC is Theralase's partner of choice to provide a continuous supply of the lead PDC for future clinical trials and eventually commercialization of the PDC for human bladder cancer applications.
Roger Dumoulin-White, president and chief executive officer of Theralase, stated: "Theralase is delighted that we have partnered with SAFC in the development and manufacture of our PDCs, as they have the depth and experience to execute on the manufacture of our PDCs quickly, efficiently and in whatever quantity is required. SAFC brings a very sophisticated and experienced team of analytical and developmental chemists to the table, whose expertise will prove indispensable in the development and commercialization of our anti-cancer technology."
Dr. Arkady Mandel, chief scientific officer of Theralase, stated: "SAFC has been selected as our chosen partner in the development of our PDC platform because of their manufacturing expertise. I was extremely impressed with the knowledge and experience that their team brings to the development of our PDCs." |
