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First Oncolytic Viral Therapy Approved for Head and Neck Cancer

Posted on: 27 November 2005, source: Business Wire
Shanghai Sunway Biotech Co. Ltd. announced today that the Chinese State Food and Drug Administration (CFDA) has approved H101, an oncolytic adenovirus, to be used in combination with chemotherapy as a treatment for patients with late stage refractory Nasopharyngeal cancer, a type of head and neck cancer prevalent in China. This marks the first oncolytic viral therapy approved by any regulatory agency in the world.
H101 is a modified adenovirus, a type of common cold virus found in most people. The deletion of an E1B-55kd segment in the virus results in its ability to selectively replicate in and kill tumor cells, while leaving normal cells unaffected. The therapy has a very good safety profile -- for most patients the main side effect is fever. The CFDA approval is based on a multi-center, randomized parallel-group study comparing 5-fluorouracil and cisplatin-based chemotherapy with and without H101. The H101 study group demonstrated a 27% increase in the number of patients who had complete or partial tumor size reduction compared to the control group.