Light Sciences' Lead Cancer Compound Recommended for Japanese Market Approval

29-Sep-2003

Light Sciences announced 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(TM), 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 & CEO. "We've been highly encouraged by the outstanding safety profile of LS11 and believe 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.

Litx is based on a next-generation model of light activated drugs using tiny, cost-effective light emitting diodes (LEDs) for light generation and delivery at the site of treatment. Litx is designed to treat localized disease and is initially being studied in patients with solid tumors that have failed prior treatments including surgery, radiation and/or chemotherapy.

According to the American Cancer Society, over 550,000 cancer patients who reach this stage of disease will die this year -- more than 1,500 people a day. Litx is also in preclinical studies as an interventional treatment for cardiovascular disease and a Phase I study is ongoing in eye disease.

https://www.bionity.com/en/news/29052/light-sciences-lead-cancer-compound-recommended-for-japanese-market-approval.html