FDA fast-tracks Favrille's FavId

16 January 2006

Favrille, a San Diego, USA-based developer of cancer treatments, says that the Food and Drug Administration has given the company's personalized cancer treatment a fast-track designation.

The company is in late-stage clinical trials for its FavId (idiotype vaccine) cancer treatment, which is based on genetic information extracted from patients' tumors. Favrille is testing the product following treatment with Genentech/Biogen Idec/Roche's Rituxan (rituximab) for patients with follicular B-cell non-Hodgkin's lymphoma, a cancer of the immune system.

Favrille started enrolling patients into the trial in July 2004 and plans to complete the targeted 342 patients soon. The company expects to begin releasing information on the study's secondary endpoint, response improvement, in the fourth quarter. Primary endpoint data showing how the combined treatment slowed the progression of the disease should be available by the second half of 2007, it says.

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