Breast Cancer Vaccine Suffers Setback in Late-Stage Trial

Theratope, an experimental therapeutic vaccine for women with advanced breast cancer, failed to produce the expected benefits in the last phase of clinical trials of the drug, according to German drugmaker Merck KGaA and Canada's Biomira Inc.

"The results from a large pivotal Phase III trial did not meet the two pre-determined statistical endpoints of time to disease progression and overall survival," Merck and Biomira said in a statement.

However, one group of patients in the treatment group, women on hormonal treatment following chemotherapy, "appeared to show a favorable trend to improvement in survival," the statement added.

"We had certainly hoped to announce something different from this trial," Biomira Chief Executive Alex McPherson said in a conference call.

The trial involved 1,030 women at more than 120 sites in 10 countries. About one third of the women were among the subset that showed some signs of improvement.

Merck and Biomira said further analysis of this subset was underway, and the companies planned to begin discussions of the results in this group with regulators in the United States, Canada and Europe in three to five months.

Other Sources: Biomira, Inc.