Progress in Clinical Trial with Pharmexa's AutoVac HER-2 DNA Pharmaccine for Breast Cancer


HOERSHOLM, Denmark, June 6, 2002 (PRIMEZONE) -- In July 2001 Pharmexa initiated a phase I/II clinical trial of the AutoVaca(TM) HER-2 DNA pharmaccine at clinical centers in Denmark for the treatment of breast cancer. Further centers were enrolled in the United Kingdom three months later and the trial is now running in four centers in Denmark and two centers in the United Kingdom. A total of 27 patients will be enrolled in the trial with the objective of evaluating safety, tolerability and immune response of the pharmaccine at three different dosage levels.

Treatment of the first 9 patients at the first (lowest) dosage level has now been successfully completed and the preliminary data are available. The recruitment of patients for the second dosage level has likewise been completed and the results are now being analyzed. The preliminary data from the first two dosage levels show that Pharmexa's pharmaccine is safe and well tolerated by the patients. An analysis of immune response has so far only been conducted for the first dosage level, but the preliminary results show immune responses in some patients even at this low dosage level. Following this, Pharmexa has now initiated recruitment of the last 9 patients at the third dosage level. The results for the trial are planned for release before the end of the year.

How does the AutoVaca HER-2 DNA pharmaccine work? The AutoVaca HER-2 DNA pharmaccine works by stimulating the patient's own immune system to induce a strong CTL ("killer cells") response against cancer cells over expressing the HER-2 protein. The HER-2 protein is a growth factor receptor present in many cancers, including breast, ovary, uterus, stomach, bladder, prostate, colon and lung cancers.

The HER-2 growth factor is found in up to 25% of breast cancers, and is usually associated with a poor prognosis for the patient. Besides chemotherapy, other treatment options exists against breast cancer, including the monoclonal antibody product Herceptin(R), which also works by targeting the HER-2 protein. This drug is in the process of achieving status as first choice treatment in the United States and generates annual sales exceeding $500 million. The AutoVac(TM) HER-2 DNA pharmaccine is one of two Pharmexa pharmaccines targeting the HER-2 protein. The other is the AutoVac(TM) HER-2 Protein pharmaccine that is designed to induce a strong antibody response. This pharmaccine is currently in late pre-clinical phase.

Pharmexa, Hoersholm
Soeren Mouritsen, Chief Executive Officer
+45 4516 2525

Jakob Schmidt, Chief Financial Officer
+45 4516 2525