Pharmexa has started phase II trial in liver cancer with GV1001
The first patient has been treated in the HeptoVax phase II trial of GV1001 in liver cancer, following receipt of the required approvals in France, Spain and Germany. The HeptoVax trial is a phase II trial evaluating the safety and efficacy of GV1001 in advanced hepatocellular carcinoma ("HCC" or "liver cancer"). The trial will enrol patients from three centres in Spain, France and Germany.
Up to 41 patients with advanced stage liver cancer will receive a single pre-treatment dose of the chemotherapeutic drug cyclophosphamide three days prior to the start of immunotherapy, followed by doses of GV1001 plus GM-CSF three times in the first week, and once weekly in week 2,3,4 and 6. Thereafter, GV1001 plus GM-CSF will be given once a month. All patients will be treated for a minimum of 6 months unless they show symptomatic progression, in which case patients will be discontinued from the trial.
The primary endpoint of the trial is efficacy, measured by objective tumor response (modified RECIST). Secondary endpoints include the safety and immunogenecity of the vaccine. Approximately half of the patients with advance stage liver cancer die within a year and survival benefits in the trial will also be measured.
Depending on the speed at which patients can be recruited, results from the trial will therefore be available in the first half of 2008. If the results are positive, Pharmexa plan to initiate a pivotal phase III trial of GV1001 in liver cancer.
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