PHARMEXA DISCONTINUES BREAST CANCER VACCINE TRIAL

Following a review of the preliminary data from the Phase II trial of its breast cancer vaccine PX 104.1, Pharmexa has decided to stop recruitment of new patients.

The company has put on hold the HER-2 Protein AutoVac (PX 104.1) trial, in which the vaccine is tested together with the adjuvant QS-21. For this decision, Pharmexa has made use of the trial's data monitoring committee, as well as external experts. A total of 14 patients with stage IV metastatic breast cancer were treated with the vaccine.

The preliminary data shows that the vaccine was not able to slow down the cancer in the first 10 included patients. The patients progressed during the study period, and they were therefore taken off the study according to the protocol and offered other treatments. The remaining patients will be treated according to the protocol before the trial is put on final hold. Based on the preliminary results, it is unlikely that the trial would meet its primary endpoint, objective tumor response, if it was completed.