Seattle-based Light Sciences reported that Meiji Seika, the licensor of its lead compound, LS11 (Laserphyrin in Japan), received a recommendation for approval by Pharmaceutical Affairs and Food Sanitation Council of the Ministry of Health, Labor and Welfare in Japan. The approval will be granted for the photodynamic treatment of early endobronchial carcinoma.
The Japanese regulatory decision in the world’s second largest healthcare market comes as Light Sciences has successfully completed a phase I/II study of its lead combination product, Litx, in patients with advanced stage solid cancers. One of the key components of the Litx System is the light activated LS11 drug.
“The Japanese recommendation for approval of our lead drug coincides with the initiation of our Phase II oncology program internationally,” stated Dr. Albert Luderer, Light Sciences’ president and chief executive. “This regulatory milestone sets a positive tone for the next phase of Litx evaluation.”
Light Sciences licensed LS11 from Nippon Petrochemicals and Meiji Seika Kaisha in early 2000, and has exclusive rights to develop, make and commercialize the compound for use in photodynamic therapy in multiple therapeutic applications worldwide, outside of Japan.
