Pharmexa stops phase 2 breast cancer trial

By Elaine Rigoli

Tampa, Fla., Aug. 14 - Pharmexa A/S said it has decided to stop further recruitment of patients to the HER-2 Protein AutoVac (PX 104.1) phase 2 trial in which the breast cancer vaccine is tested together with the adjuvant QS-21.

Based on the preliminary results, the company said it is unlikely that the trial would meet its primary endpoint, objective tumor response, if it was finalized. Therefore the trial has been stopped.

The termination of the phase 2 trial means that Pharmexa's clinical costs are reduced for the coming years. For the financial year 2006, the termination will lead to a cost saving of about DKK 4 million, while the expected savings in 2007 and 2008 will total about DKK 2 million compared to budget.

The preliminary data shows that the HER-2 Protein AutoVac 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.

No serious adverse events related to the vaccine have been reported in the trial. The trial had, at this time, met its secondary endpoints, immune response and safety, according to a news release.

"We are disappointed about these results. It looks like the patients simply progress before the vaccine has a chance to work. Although the antibody data are interesting and the number of patients treated is small, the conclusion is clear: There is no basis for continuing this trial in very ill metastatic breast cancer patients. Either the patients must be healthier or the vaccine must work faster," chief executive officer Jakob Schmidt said in the release.

For this decision, Pharmexa said it used the data monitoring committee that was established in connection with the trial, as well as external experts. A total of 14 patients with stage IV metastatic breast cancer have been treated with the vaccine.

Pharmexa is a pharmaceutical company based in Horsholm, Denmark.

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