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Theratope Vaccine Phase III Study Continuation Recommended.(Brief Article)
2001 DEC 26 - (NewsRx.com & NewsRx.net) -- Biomira, Inc., announced that an independent Data Safety Monitoring Board (DSMB) has reviewed data from all of the patients enrolled in its pivotal Phase III trial with Theratope vaccine.
The DSMB recommendation was that Biomira continue its Phase III study for metastatic breast cancer as planned. This is the DSMB's fourth safety review of the trial.
"Having reviewed the safety data, the DSMB feels the trial should continue without any modifications," members of the DSMB stated.
"We are encouraged by the news from the DSMB and this is a further milestone as the Theratope vaccine study moves forward," commented Alex McPherson, MD, PhD, Biomira. "Once again, our product candidate is generally well-tolerated, and supports our confidence as we move towards potential regulatory approval. ...
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