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Pharmexa to start phase 2 trial in France testing GV1001 in liver cancer
By Elaine Rigoli
Tampa, Fla., Aug. 30 - Pharmexa a/s said Wednesday that it received the necessary approvals in France to start the Heptovax phase 2 trial of its GV1001 vaccine for the treatment of liver cancer.
The company said approvals in Spain and Germany are expected within the next few weeks.
The Heptovax trial will evaluate the safety and efficacy of GV1001 in advanced hepatocellular carcinoma in up to 41 patients, who 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 two, three, four and six. Thereafter, GV1001 plus GM-CSF will be given once a month.
All patients will be treated for a minimum of six months unless they show symptomatic progression, in which case patients will be discontinued from the trial, according to a company news release.
The primary endpoint is efficacy, measured by objective tumor response. Secondary endpoints include the safety and immunogenecity of the vaccine.
Pharmexa, based in Horsholm, Denmark, develops immunotherapy and vaccines for the treatment of serious chronic and infectious diseases.
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