Toronto, ON – June 7, 2004 – Biotech company Viventia Biotech says it has begun a second Phase I clinical trial for the treatment of head and neck cancer with its lead product candidate, Proxinium. This clinical trial involves a more intensive dosing regimen than Viventia’s previously announced Phase I head and neck cancer study and furthers the company’s plans to potentially implement Phase II studies in this indication in 2005.
This multi-centre study is to be carried out in four medical centers in Brazil, a jurisdiction whose clinical trial data has been recognized by regulatory authorities such as the FDA. The study design incorporates a dose- escalation protocol in which Proxinium is administered to patients diagnosed with advanced, recurrent head and neck cancer, a condition with limited therapeutic options. The primary objectives of the study are to determine the drug’s safety and tolerability. In addition, a series of efficacy parameters will also be measured, including objective tumor response measurements as determined by radiographic analysis. Enrolment is expected to involve approximately 24 patients, and the trial is anticipated to be completed within 9 months.
Viventia’s previously announced Phase I clinical trial with the drug in Russia is nearing completion. To date, 18 patients have been enrolled, and there have been no dose limiting toxicities observed in the study. The trial, which began in December 2003, is expected to complete enrolment in July 2004.