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Biomira Plans Interim Analysis Of Theratope Vaccine Data.(Brief Article)
2001 NOV 15 - (NewsRx.com & NewsRx.net) -- Merck KGaA and Biomira Inc. (BIOM) have announced that, following communications with the U.S. Food and Drug Administration (FDA), the companies will conduct a single interim analysis of data from their Phase III trial for Theratope vaccine, a treatment in development for women with metastatic breast cancer. The analysis is expected to occur in the third quarter of next year, and is anticipated to be the only interim analysis performed in connection with this study. It will be followed, if necessary, with a final analysis toward the end of 2003. Theratope vaccine has fast track designation with the FDA.
The companies' decision to amend the analysis plan to a single, interim analysis was determined to be acceptable by the FDA. Furthermore, the FDA affirmed that a single, multicenter pivotal trial of excellent design, which demonstrates statistically strong evidence of important clinical benefit, would be acceptable to support a license ...
- First patient enrolled in Theratope vaccine phase II trial.(Biomira Inc. and...
- Newspaper article from: Immunotherapy Weekly October 30, 2002 700+ words
...clinical development of Theratope vaccine. Biomira and Merck KGaA completed enrollment in a phase III Theratope vaccine clinical trial for...s collaborator for Theratope vaccine is Merck KGaA, of Darmstadt, Germany...
- First patient enrolled in Theratope vaccine phase II trial.(breast cancer...
- Magazine article from: Women's Health Weekly October 31, 2002 700+ words
...clinical development of Theratope vaccine. Biomira and Merck KGaA completed enrollment in a phase III Theratope vaccine clinical trial for...s collaborator for Theratope vaccine is Merck KGaA, of Darmstadt, Germany...
- First patient enrolled in Theratope vaccine phase II trial.(breast cancer...
- Newspaper article from: Cancer Weekly October 29, 2002 700+ words
...clinical development of Theratope vaccine. Biomira and Merck KGaA completed enrollment in a phase III Theratope vaccine clinical trial for...s collaborator for Theratope vaccine is Merck KGaA, of Darmstadt, Germany...
- First patient enrolled in Theratope vaccine phase II trial.
- Newspaper article from: Biotech Week October 30, 2002 700+ words
...clinical development of Theratope vaccine. Biomira and Merck KGaA completed enrollment in a phase III Theratope vaccine clinical trial for...s collaborator for Theratope vaccine is Merck KGaA, of Darmstadt, Germany...
- First patient enrolled in Theratope vaccine phase II trial.(metasatic breast...
- Newspaper article from: Vaccine Weekly October 30, 2002 700+ words
...clinical development of Theratope vaccine. Biomira and Merck KGaA completed enrollment in a phase III Theratope vaccine clinical trial for...s collaborator for Theratope vaccine is Merck KGaA, of Darmstadt, Germany...
- Metastatic breast cancer vaccine trial to continue.(Theratope vaccine)
- Magazine article from: Women's Health Weekly November 28, 2002 700+ words
...Canada, and Merck KGaA of Darmstadt...clinical trial of Theratope vaccine through its planned...Biomira and Merck KGaA, which are collaborating...development of Theratope vaccine, reached this...Biomira and Merck KGaA remain blinded...
- Data from Theratope Vaccine trial presented.
- Newspaper article from: Cancer Weekly January 6, 2004 700+ words
...BRA) and Merck KGaA of Darmstadt...analysis of their Theratope Vaccine phase III clinical...patients receiving Theratope vaccine and those on...the impact of Theratope vaccine therapy on...collaborator Merck KGaA announced in...
- Trial results for Theratope vaccine presented.
- Newspaper article from: Biotech Week June 25, 2003 700+ words
...Canada, and its collaborator, Merck KGaA of Darmstadt, Germany, announced...Biomira's phase II study of Theratope vaccine in the treatment of metastatic...said McPherson. Biomira and Merck KGaA completed enrollment in the phase...