200 Patients Enrolled in Clinical Trial to Assess Survival of Patients Receiving Litx versus Standard of Care Therapies for Unresectable Hepatocellular Carcinoma
BELLEVUE, Wash., Nov. 25 /PRNewswire/ -- Light Sciences Oncology, Inc. (LSO) today announced the completion of enrollment in a global Phase 3 clinical trial of Light Infusion Therapy(TM) (Litx(TM)) as a treatment for unresectable hepatocellular carcinoma (HCC), also known as hepatoma or primary liver cancer.
The two-armed, randomized clinical trial has enrolled 200 patients at sites in the Philippines, Korea, India, Malaysia, Thailand, Hong Kong, Singapore, Serbia, Poland, Croatia, and Italy. The primary endpoint of the clinical trial is to assess the survival of patients receiving Litx therapy versus those receiving standard-of-care therapies.
"We are pleased to have enrolled the final patient in this pivotal clinical trial of Litx in primary liver cancer," said Llew Keltner, M.D., Ph.D., president and CEO of Light Sciences Oncology. "We look forward to seeing a statistically significant survival benefit of Litx and proceeding with a New Drug Application to the U.S. FDA, EMEA, and other regulatory authorities in 2009."
HCC represents a great unmet medical need, with no effective treatments now available for the vast majority of patients. According to the 2005 edition of Cancer, Principles & Practice of Oncology, there are approximately one million new cases of HCC worldwide each year and, according to an article published in the Journal of Hepatology in 2004, HCC kills approximately one million people worldwide each year.
About Light-Infusion Therapy (Litx)
Litx is designed as an entirely new mode of therapy compared with the older, laser-based generation of light-activated drug therapies. The single-use, disposable Litx device uses light-emitting diodes (LEDs) to activate LS11(
|SOURCE Light Sciences Oncology, Inc.|
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