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news.Favrille has reached the data cutoff date for the company's Phase III registration trial of Specifid, following Rituxan in patients with follicular B-cell non-Hodgkin's lymphoma.
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As of the data cutoff date, 205 of the 349 patients randomized have experienced disease progression (relapsed) according to investigator determination. Median follow-up for ongoing patients is 31 months from randomization (range 21 to 41 months), or approximately 34 months from the initiation of Rituxan treatment (range 24 to 44 months). Based on the protocol’s assumptions, this range of follow-up would provide sufficient power to detect a significant difference between the two arms for time to progression, the primary endpoint in the trial.
Final analysis will be based on a central radiology assessment of the patients’s CT scans. Unblinding of the data is expected to occur in June 2008.
John Longenecker, president and CEO of Favrille, said: “Based on the status of patients at data cutoff and our assumptions about the behavior of the control arm in this trial, we are very encouraged that the upcoming analysis will provide an outcome which is both clinically and statistically significant.”