Breast cancer vaccine well tolerated and safe in clinical trial patients.

2004 APR 14 - (NewsRx.com & NewsRx.net) -- Pharmexa announced that data from the first clinical trial in the U.S. with the HER-2 Protein AutoVac vaccine show that the vaccine is well tolerated and safe and that it induces significant HER-2 specific antibodies in breast cancer patients.

Based on these results, Pharmexa plans the continued development of the vaccine through additional clinical investigations in the second half of 2004.

The vaccine is designed to induce antibody responses against the HER-2 protein that is over expressed in many human cancers, including some cancers of the breast. Breast cancer patients received four injections of the vaccine formulated in a standard aluminium adjuvant.

HER-2 specific antibody responses were detected in 6 out of 10 patients in the trial. The first responses were detected after only two injections and were significantly boosted following subsequent immunizations.

Additional responders were also detected after the third and fourth immunizations.

The peak antibody concentration detected in patient sera was approximately 2 micrograms per mL and the average for all six responders was 0.8 micrograms per mL with a decline to approximately half the peak value within 4 weeks following cessation of treatment.

The vaccine was well tolerated and there were no serious safety concerns associated with the treatment.