Favrille, Inc. Announces Status of Patient Enrollment in Phase III Registration Trial
Related News: Stem Cell Companies, Stem Cell InvestmentSAN DIEGO, May 31 - Favrille, Inc. (Nasdaq:FVRL), a biopharmaceutical company developing targeted immunotherapies for cancer and diseases of the immune system, announced today that it has enrolled 220 eligible patients into its Phase III registration clinical trial testing its lead product candidate, FavId(R), following Rituxan(R) in patients with follicular non-Hodgkin's lymphoma (NHL).
This represents approximately 65% of the 342 randomized, evaluable patients required to be enrolled in the trial. As originally projected, the Company expects to complete enrollment on schedule by year end.
"We are very excited to report the status of patient enrollment in our Phase III trial," said John P. Longenecker, Ph.D., President and Chief Executive Officer of Favrille. "We believe that the rapid enrollment rate, 65% in the first 10 months, is an indication of investigators' and patients' enthusiasm for this all-biologic treatment for NHL which avoids the side effects of chemotherapy and adds an active immunotherapy component to the known benefits of Rituxan."
Favrille is conducting its Phase III registration trial under a Special Protocol Assessment (SPA) from the FDA. An SPA is a written agreement with the FDA on the overall design and planned analysis of the trial and can only be granted prior to initiation of the clinical trial. An SPA may be modified only if the FDA agrees that the modifications improve the clinical trial. The FDA has agreed to a modification to Favrille's SPA which removes the cap on the proportional enrollment of treatment-naive and relapsed/refractory patient subgroups into the trial.
Source: Favrille, Inc.
Posted on May 31, 2005 04:54 PM