Pharmexa Files the First Phase III Application


HOERSHOLM, Denmark, Feb. 1, 2006 (PRIMEZONE) -- Pharmexa has filed an application to obtain approval to initiate the phase III trial with GV1001 in Ireland. Further applications will be filed in a number of countries in the coming weeks. 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 applications 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).

Jakob Schmidt, CEO in Pharmexa says: "Filing of our first phase III application is an important milestone in Pharmexa's history. The phase III 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."

GV1001: 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.

To date, GV1001 has been tested in seven small clinical studies in non-small cell lung cancer (NSCLC), malignant melanoma and pancreatic cancer. More than 120 patients have so far been vaccinated with GV1001, with significant signs of clinical effect and no major side effects.

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

Note to editors: Pharmexa A/S is a leading company in the field of active immunotherapy and vaccines for the treatment of serious chronic and infectious diseases. 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. Its leading programs are GV1001, a peptide vaccine about to enter phase III trials in pancreatic cancer, HER-2 AutoVac(TM) Protein, a recombinant protein vaccine in phase II against breast cancer, and HIV and hepatitis vaccines in phase I/II. Collaborative agreements include H. Lundbeck, Innogenetics, IDM Pharma and Bavarian Nordic. With operations in Denmark, Norway and USA, Pharmexa employs approximately 100 people and is listed on the Copenhagen Stock Exchange under the trading symbol PHARMX.