Pharmexa files for approval of first phase 3 trial for GV1001 cancer drug

By E. Janene Geiss

Philadelphia, Feb. 1 - Pharmexa AS said Wednesday that it has filed an application with authorities in Ireland to obtain approval to begin a phase 3 trial with GV1001 in inoperable patients with pancreatic cancer.

Further applications will be filed in Sweden, Norway, the Netherlands, Australia and Spain in the coming weeks, according to a company news release.

The trial, sponsored by Pharmexa and planned in collaboration with a number of clinical advisers, includes 520 patients from about 60 centers in Australia, Belgium, Denmark, France, Ireland, Italy, the Netherlands, Norway, Poland, Spain, Sweden, Czech Republic and Germany, officials said.

The trial will test GV1001 side-by-side with the current standard treatment gemcitabine, a chemotherapeutic drug approved for the treatment of pancreatic cancer.

"Filing of our first phase 3 application is an important milestone in Pharmexa's history. The phase 3 program with GV1001 has been met with significant interest from a number of cancer doctors in the countries involved. It is obvious that there is a great need for an improved treatment of this terrible disease and a desire to get started as soon as possible," Jakob Schmidt, chief executive officer, said in the release.

Pharmexa has a European patent on GV1001 and has obtained a so-called Notice of Allowance from the U.S. Patent Office.

To date, GV1001 has been tested in seven small clinical studies in non-small cell lung cancer, malignant melanoma and pancreatic cancer.

More than 120 patients so far have been vaccinated with GV1001 with significant signs of clinical effect and no major side effects, officials said.

Pharmexa and the company's collaborators are currently preparing two phase 3 trials with GV1001 in pancreatic cancer based on promising data in this indication. These two phase 3 trials, the PrimoVax and the TeloVax trial, will enroll patients with inoperable pancreatic cancer, which is 90% of all pancreatic cancer patients, and collectively include more than 1,600 patients, officials said.

Pharmexa is a Hoersholm, Denmark, biotechnology company with a focus in the field of active immunotherapy and vaccines. Pharmexa's proprietary technology platforms are broadly applicable, allowing the company to address critical targets in cancer, rheumatoid arthritis, bone degeneration and Alzheimer's disease, as well as serious infectious diseases such as HIV, influenza, hepatitis and malaria.

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