Theralase Technologies' (Toronto, ON, Canada) proprietary photodynamic compound (PDC) technology has been approved for use in a live animal bladder cancer model by the University Health Network (UHN; also in Toronto) Research Ethics Board. The approval expedites the companyâs progress towards commercializing its advanced bladder cancer therapy.
Theralase's PDC has demonstrated that it is toxic to bladder cancer cells when light-activated, with 100% kill rate. The company will validate its PDC technology in the animal cancer model to support an Investigational New Drug (IND) application to be filed with the FDA later this year. The IND application will allow the company to commence a Phase 1/2a human clinical trial to prove the safety and efficacy of its PDC technology on 30 subjects, with scheduled completion in 2014.
Based on recent pharmaceutical acquisitions for oncology drugs and market statistics, the estimated value of the PDC upon successful completion of the clinical trial ranges from $84 million to $360 million in upfront payments, followed by a double-digit revenue royalty stream, says BIO statistics.
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