Pharmexa moves ahead with phase 3 trial of GV1001 for pancreatic cancer

By Lisa Kerner

Erie, Pa., April 26 - Pharmexa said it has is approval to move forward with the phase 3 study for its immune system-activating peptide vaccine, GV1001.

The PrimoVax trial of 520 patients with pancreatic cancer will test GV1001 side by side with gemcitabine, a chemotherapy drug approved for the treatment of pancreatic cancer, at 60 centers in Europe and Australia.

A previous phase 1/2 clinical trial showed that treatment with GV1001 as monotherapy significantly prolonged the survival for pancreatic cancer patients, compared to gemcitabine, according to a company news release.

Survival is the primary endpoint in the PrimoVax trial, with a secondary endpoint of time to progression, or duration of time until the patients are worse as measured by objective criteria.

Nine out of 10 of the 230,000 patients diagnosed with pancreatic cancer are considered inoperable, with an expected survival time of only 3 to 6 months.

Located in Hørsholm, Denmark, Pharmexa develops immunotherapy and vaccines for the treatment of chronic and infectious diseases.

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