Denmark-base biopharmaceutical firm Pharmexa A/S (PHARMX) has obtained approvals in France to start the Heptovax Phase II trials, with approvals from Spain and Germany still pending.
The trials will assess GV1001's safety and efficacy in advanced hepatocellular carcinoma (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.
In theory, GV1001 could therefore turn out to be a universal cancer vaccine and Pharmexa's development strategy for GV1001 reflects this.
Pharmexa is expecting the trial to be concluded in early 2008, and pending results, a pivotal Phase III trial will then be initiated.
Details of the study design are described in Pharmexa's press release.
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