State Food and Drug Administration (SFDA) 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. Shanghai Sunway reports that the therapy has a very good safety profile, with most patients experiencing fever as the main side effect.
The SFDA 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.
Dr Fang Hu, Sunway’s president and CEO said: “Moving forward, we will continue the clinical trials to test for H101’s additional indications including non-small cell lung cancer. At the same time, we are preparing to take the therapy to the world market. Sunway is well-positioned to reach this goal because of its exclusive worldwide rights to oncolytic adenoviral therapy, the clinical success of H101 in China, and the initial trial results of Onyx-015 in the US.”