Vaxon Biotech Successfully Completes its Phase I/II Trial of Vx-001 Cancer Vaccine
News May 21, 2010
Vaxon Biotech, a specialist in tumor immunotherapy, announces today the successful conclusion of the 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.
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 (only grade I vaccine related toxicity was observed) and well tolerated by the patients, that it induces a long lasting vaccine specific immune response in 70 percent of patients, and that it has a significant clinical activity: four patients experienced objective response and 33 patients stabilized their disease for more than six months.
Survival of vaccinated patients was related to the immune response; patients who developed immune response had a longer survival than patients who failed to do so. Analysis focused on the thirty-three NSCLC showed that Vx-001 induces long lasting disease control, including objective responses, in more than 42 percent of patients. Survival of NSCLC vaccinated with Vx-001 was close to 19 months, at least 50 percent longer than normal in this patient population.
On the basis of this successful phase I/II trial and the very promising 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 authorization after the completion of this trial.