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Data from Theratope Vaccine trial presented.
2004 JAN 7 - (NewsRx.com & NewsRx.net) -- Biomira, Inc., (BIOM, BRA) and Merck KGaA of Darmstadt, Germany, announced that data from the final analysis of their Theratope Vaccine phase III clinical trial in women with metastatic breast cancer were presented at the 26th Annual San Antonio Breast Cancer Symposium (SABCS).
David W. Miles, MD, BSc, FRCP, senior lecturer, and honorary consultant in medical oncology at Guy's Hospital in London, England and principal clinical investigator in the trial presented the results in an oral presentation. Alex McPherson, president and CEO of Biomira, Inc., and Nancy Wysenski, president of EMD Pharmaceuticals, Inc., Merck KGaA's wholly owned U.S. subsidiary, later discussed this presentation and the trial results in a conference call.
Theratope is an investigational therapeutic cancer vaccine that consists of a synthetic version of the tumor-associated antigen Sialyl Tn (STn) linked to the protein carrier, keyhole limpet hemocyanin (KLH), and is designed to stimulate an immune response to STn.
The phase III trial randomized 1028 women with metastatic breast cancer. The primary objectives of the trial were to compare time to disease progression and survival in patients receiving Theratope vaccine and those on the KLH control arm of the study. Secondary objectives were to document the product safety profile, to measure anti-STn, anti-OSM, and anti-KLH antibody titres and to evaluate the impact of Theratope vaccine therapy on patients' health-related quality of life.
Biomira and its collaborator Merck KGaA announced in June that the phase III trial of Theratope did not meet the two pre-determined statistical endpoints of time to disease progression and overall survival. However, in one pre-stratified subset of more than 300 women who received hormonal treatment following chemotherapy, those on the Theratope arm appeared to show a favorable trend toward improvement in survival.
Exploratory analyses were conducted, that included five ...
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Source: HighBeam Research, Data from Theratope Vaccine trial presented.