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news.Vaxon Biotech, a company into tumor immunotherapy, has completed Phase I/II trial of its Vx-001 therapeutic cancer vaccine. As a result, Vaxon is pursuing the clinical development of Vx-001 by launching a pivotal Phase III trial in non-small cell lung cancer (NSCLC) in 2010, and in hepatocellular carcinoma and breast cancer in 2012-2013.
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Vaxon Biotech said that the Phase I/II trial was conducted among 116 patients with different types of cancer including 33 patients with NSCLC. The primary objective was to evaluate safety of Vx-001, with a secondary objective to evaluate immune response and clinical response. Results showed that Vx-001 is safe and well tolerated by the patients, that it induces a long lasting vaccine specific immune response in 70% of patients.
Reportedly, in the trial four patients experienced objective response and 33 patients stabilised their disease for more than six months. Analysis focused on the thirty-three NSCLC showed that Vx-001 induces long lasting disease control, including objective responses, in more than 42% of patients.
On the basis of this successful Phase I/II trial and positive results in NSCLC, the European Medicines Agency (EMA) has approved the design of the planned pivotal Phase III study and agreed to consider Vx-001 for marketing authorisation after the completion of this trial.
Kostas Kosmatopoulos, CSO of Vaxon Biotech, said: “We are delighted that Vaxon will become one of the biotech companies to have a product in a late stage of clinical development.”