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Pharmexa receives approval of Phase II application with GV1001 in liver cancer


Summary: Pharmexa has received the necessary approvals in France to start the Heptovax Phase II trial with GV1001 in liver cancer.

Pharmexa has received the necessary approvals in France regarding the Heptovax Phase II trial with GV1001 in liver cancer and will now initiate recruitment of patients. Approvals in Spain and Germany are expected within the next few weeks.

The Heptovax trial is a Pase II trial evaluating the safety and efficacy of GV1001 in advanced hepatocellular carcinoma (“HCC” or “liver cancer”). The trial will enrol patients from 3 centres in Spain, France and Germany.

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 early 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, occurring 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, August 30, 2006
Jakob Schmidt
Chief Executive Officer

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 is expected to enter a phase II trial in liver cancer soon, as well as a number of 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.


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