Norwegian clinic to start phase 2 study of Pharmexa vaccine in lung cancer

By Lisa Kerner

Charlotte, N.C., June 15 - The Cancer Clinic in Norway has submitted an application with Norwegian authorities to begin a phase 2 trial of Pharmexa A/S' GV1001 in non-small cell lung cancer.

Pharmexa will supply GV1001, its cancer vaccine, for the trial, which is partly funded by the Norwegian Research Council, according to a company news release.

In the planned open label exploratory phase 2 trial, patients with stage 3A and stage 3B non-small cell lung cancer will be treated with GV1001 together with the adjuvant GM-CSF following radiation treatment.

Patients will be immunized three times in the first week, once weekly in weeks two, three, four, six, eight and 10, and once a month for three months and in months six and nine.

The primary end-point in the trial is immune response measured by T-cell responses and DTH, with secondary endpoints of safety and time to progression.

Results from the trial are expected in early 2000.

Pharmexa said it has also started a phase 3 trial with GV1001 in pancreatic cancer and plans a phase 2 trial with GV1001 in liver cancer.

Based in Horsholm, Denmark, Pharmexa develops immunotherapy and vaccines for the treatment of cancer, serious chronic diseases and infectious diseases.

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