The study, which was conducted in Brazil, enrolled 20 patients who had advanced head and neck cancer and continuing disease progression, with all patients having failed previous courses of surgery, chemotherapy and/or radiotherapy. The patients received a Proxinium injection directly into a target tumor on a weekly basis for four weeks.
Preliminary efficacy analysis showed that 25% of the 16 evaluable patients who expressed the therapeutic target for Proxinium had a complete response to therapy (complete disappearance of treated tumor), 63% had an objective response (significant or partial shrinkage of treated tumor), and 88% had tumor growth control (objective response or stabilization of disease).
The drug was also reported to have a good safety profile and was well tolerated, consistent with previous results.
“To have achieved such a high number of complete responses in patients that have, in essence, failed all other available therapies is very encouraging,” said Dr Nick Glover, president and CEO of Viventia. “These results, and the promising survival data that emerged from our previous phase I trial, show the tremendous potential for Proxinium for the treatment of refractory head and neck cancer.”