Pharmexa receives approval of Phase II application with GV1001 in liver cancer
Pharmexa has received the necessary approvals in France regarding the Heptovax Phase II trial with GV1001 in liver cancer and will now initiate recruitment of patients. Approvals in Spain and Germany are expected within the next few weeks. The Heptovax trial is a Pase II trial evaluating the safety and efficacy of GV1001 in advanced hepatocellular carcinoma ("HCC" or "liver cancer"). The trial will enrol patients from 3 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 early 2008. If the result are positive, Pharmexa plan to initiate a pivotal Phase III trial of GV1001 in liver cancer.
GV1001 is a peptide vaccine that activates the immune system - primarily the immune system's T-cells - to recognize and kill cancer cells. GV1001 targets an enzyme called telomerase. Telomerase is seldom found in normal cell types but is over expressed in most cancer cells. In scientific circles, telomerase activity is considered a key factor in the process whereby cancer cells lose their normal mortality, which is a common feature for all cancers.
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