Pharmexa will start phase II trial in liver cancer with GV1001
Pharmexa has submitted the application to initiate the Heptovax phase II trial. The trial is planned to start in the third quarter of 2006 and will include up to 41 liver cancer patients. The Heptovax trial is a phase II, open-label trial evaluating the safety and efficacy of GV1001 in advanced hepatocellular carcinoma ("HCC" or "liver cancer"). The trial will enroll patients from 3 centres in Spain, France and Germany. The application has been submitted in France and will be submitted in Spain shortly.
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.
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. In theory, GV1001 could therefore turn out to be a universal cancer vaccine and Pharmexa's development strategy for GV1001 reflects this.
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