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Pharmexa has started phase II trial in liver cancer with GV1001

28 Nov 2006

The first patient has been treated in the HeptoVax phase II trial of GV1001 in liver cancer, following receipt of the required approvals in France, Spain and Germany.

HØRSHOLM, Denmark | Nov 27, 2006 | The HeptoVax trial is a phase II trial evaluating the safety and efficacy of GV1001 in

advanced hepatocellular carcinoma ("HCC" or "liver cancer"). The trial will enrol patients from three centres in Spain, France and Germany.

Dr. Jordi Bruix from the Liver Unit at Hospital Clinic, Barcelona, investigator in the HeptoVax study and one of the worlds leading experts in the treatment of liver cancer says: "The use of new agents such as GV1001 represents interesting pathways for developing better treatments of liver cancer. If GV1001 lives up to its promise, it may become a cornerstone in the future treatment of this dreaded disease. Its mode of action is new and it appears to be without significant side effects."

Jakob Schmidt, CEO in Pharmexa says: "We have multiple opportunities with GV1001. GV1001 is in phase III in pancreatic cancer and now also in phase II in liver cancer. In the next few months, the Rigshospitalet-Radium Hospitalet in Norway plans to start a phase II trial in lung cancer. We have chosen a broad development strategy for GV1001 because we believe the vaccine has the potential to change the way we treat cancer in the future."

Trial design
Up to 41 patients with advanced stage liver cancer will receive a single pre-treatment dose of the chemotherapeutic drug cyclophosphamide three days prior to the start of immunotherapy, followed by doses of GV1001 plus GM-CSF three times in the first week, and once weekly in week 2,3,4 and 6. Thereafter, GV1001 plus GM-CSF will be given once a month. All patients will be treated for a minimum of 6 months unless they show symptomatic progression, in which case patients will be discontinued from the trial.

The primary endpoint of the trial is efficacy, measured by objective tumor response (modified RECIST). Secondary endpoints include the safety and immunogenecity of the vaccine. Approximately half of the patients with advance stage liver cancer die within a year and survival benefits in the trial will also be measured.

Depending on the speed at which patients can be recruited, results from the trial will therefore be available in the first half of 2008. If the results are positive, Pharmexa plan to initiate a pivotal phase III trial of GV1001 in liver cancer.

Liver cancer represents a large unmet need
HCC is the fifth most common cancer in the world. More than 600,000 new cases of hepatocellular carcinoma occur worldwide each year with almost as many deaths. In Europe alone, more than 50,000 new cases occur each year. The incidence of HCC, however, varies a great deal between different countries and regions, and HCC occurs significantly more often in Japan than in Europe. Moreover, accumulating evidence indicates that the incidence of liver cancer is rising. HCC is twice as common in men as in women and has a strong association with hepatitis B and hepatitis C infection as well as with cirrhosis. Early and medium stage liver cancers are sub-optimally treated with surgery, radiofrequency ablation and chemoembolization while no treatment options really exist for the disease in its advanced stage. Current chemotherapy treatments are limited by the site of the cancer - the cirrhotic liver - because of dose limiting liver toxicity concerns with these agents.

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 and Pharmexa's development strategy for GV1001 reflects this.

Hørsholm, November 27, 2006

Jakob Schmidt
Chief Executive Officer

Additional information:
Jakob Schmidt, Chief Executive Officer, telephone +45 4516 2525
Claude Mikkelsen, Head of Investor Relations, telephone +45 4516 2525 or +45 4060 2558

Note to editors: Pharmexa A/S is a leading company in the field of active immunotherapy and vaccines for the treatment of cancer, 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 that has entered phase III trials in pancreatic cancer and phase II trials in liver cancer, and HIV and hepatitis vaccines in phase I/II. Collaborative agreements include H. Lundbeck, Innogenetics, IDM Pharma, ImmunoVaccine Technologies 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.

SOURCE: Pharmexa

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