Danish biotechnology company Pharmexa has filed an application to the authorities in Ireland seeking approval to start a Phase III trial of its lead cancer vaccine product, GV1001, in inoperable patients with pancreatic cancer.
Further applications are expected to be filed in the next two weeks in Sweden, Norway, the Netherlands, Australia and Spain, with other countries involved in the study programme following on.
The PrimoVax trial will enroll 520 patients to test GV1001 side by side with the current standard treatment for pancreatic cancer, Eli Lilly’s Gemzar (gemcitabine).
GV1001 is a peptide vaccine that activates T cells to recognise and kill cancer cells by targeting the enzyme telomerase. Telomerase is seldom found in normal cell types but is over-expressed in most cancer cells.
To date, GV1001 has been tested in seven small clinical studies in non-small cell lung cancer, malignant melanoma and pancreatic cancer. Pharmexa acquired the vaccine as part of its purchase of Norwegian biotechnology company GemVax last year.