Significant survival advantage reported in phase III trial of Theratope.

2004 JUL 7 - (NewsRx.com & NewsRx.net) -- Biomira, Inc., (BIOM, BRA) of Edmonton, Alberta, Canada, announced that an exploratory analysis showed a statistically significant survival advantage for women in the hormonal therapy subset of patients receiving Theratope vaccine as part of Biomira's phase III study of the vaccine in the treatment of women with metastatic breast cancer.

Updated results from the phase III trial, including the exploratory analysis of the hormonal therapy group of women taking Theratope for treatment of their metastatic breast cancer, were presented in a poster session at the 2004 ASCO annual meeting. Two key areas of data analysis were presented:

1) An updated survival analysis for women receiving hormonal type therapy at the same time as either Theratope or the control vaccine, and

2) An analysis of survival based on IgG antibody response to Theratope. Antibody titres were measured against the following three factors: STn, KLH (the carrier molecule), and OSM, a naturally occurring mucin that contains clustered STn side chains.

The overall survival for patients in the hormonal subset (n=350) now shows a statistically significant difference between the two treatment arms. Women in the Theratope arm (n = 180) survived a median of 36.5 months, while those in the control vaccine arm (n = 170) survived a median 30.7 months.

The Cox p = 0.039. The survival for women not receiving hormonal therapy was not significantly different between the two treatment arms. Analysis to determine a mechanism of action between Theratope and hormonal therapies are currently being conducted.

"We were gratified to see the survival advantage in the exploratory analysis of the pre-stratified subset of women who received hormonal therapy and Theratope," said Alex McPherson, MD, PhD, president and CEO.