Proxinium Demonstrates Positive Clinical Responses in Head and Neck Cancer Clinical Trial
10/27/2004 Toronto, Ontario, Canada Press Release Pharmalive.com Viventia Biotech Inc. today announced the results of the first Phase I clinical study completed with its lead product candidate Proxinium™ for the treatment of advanced, recurrent head and neck cancer. The results, which demonstrate documented tumour responses in several patients, were announced at the Rodman & Renshaw Techvest 6th Annual Healthcare Conference in New York. The study, which completed enrollment in 8 months, was primarily designed to assess the safety and tolerability of Proxinium™ monotherapy over an escalating dose range. Patients enrolled in this study had advanced head and neck cancer and continuing disease progression, and the majority had failed previous courses of chemotherapy and/or radiotherapy. Preliminary clinical data from the study strongly support the safety profile of Proxinium™, with the observation of mostly mild treatment-related side effects, such as injection site pain. In addition to positive safety outcomes, Proxinium™ treatment also resulted in several independently verified clinical responses. Of the 24 patients that were dosed in the study, 17 patients expressed the therapeutic target for Proxinium™, from which 14 patients were evaluated for their response to treatment. Of those 14 patients, two patients experienced significant tumour regressions of their treated lesions and four other patients experienced minor tumour regressions, yielding an objective response rate of 43%. Four other patients had stable disease following Proxinium™ treatment. Tumour growth control (objective responses plus stable disease) was therefore achieved in 71% of treated lesions. The historical survival rate for advanced, recurrent head and neck [...]