Pharmexa files the first phase III application for inoperable patients with pancreatic cancer

03-Feb-2006

Pharmexa has now filed an application to the authorities in Ireland in order to obtain approval to initiate a phase III trial with GV1001 in inoperable patients with pancreatic cancer. Further pplications are expected to be filed in the next two weeks in Sweden, Norway, the Netherlands, Australia and Spain. Thereafter the rest of the countries involved will follow.

The trial named PrimoVax is sponsored by Pharmexa and planned in collaboration with a number of clinical advisors. It includes 520 patients from approximately 60 centres in Australia, Belgium, Denmark, France, Ireland, Italy, the Netherlands, Norway, Poland, Spain, Sweden, Czech Republic and Germany. The trial will test GV1001 side by side with the current standard treatment, gemcitabine (a chemotherapeutic drug approved for the treatment of pancreatic cancer).

A cancer vaccine targeting Telomerase 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. Pharmexa has a European patent on GV1001 and has obtained a so-called Notice of Allowance from the US Patent Office regarding GV1001.

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