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
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
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.