Favrille: FDA clears IND for FAV-201 to treat T-cell lymphoma

By E. Janene Geiss

Philadelphia, June 15 - Favrille, Inc. said Thursday that its electronic Investigational New Drug application for FAV-201, a patient-specific immunotherapy for the treatment of T-cell lymphoma, has been cleared by the Food and Drug Administration.

Initially, FAV-201 will be evaluated in cutaneous T-cell lymphoma, according to a company news release.

Favrille said it intends to begin a phase 1/ 2 clinical trial evaluating the safety and biologic activity of FAV-201 in patients with cutaneous T-cell lymphoma.

The trial will build upon preclinical data that suggest activity of an immunotherapy based on a T-cell receptor. The multi-center trial is expected to enroll about 30 patients, officials said.

FAV-201 is a recombinant, patient-specific, T-cell receptor-based immunotherapy designed to induce an active immune response against the unique protein found on the surface of T-cells that constitute a patient's lymphoma.

Favrille said it uses a similar approach with its lead product candidate FavId for the treatment of B-cell non-Hodgkin's lymphoma.

In January, Favrille said it completed enrollment in a pivotal phase 3 clinical trial of FavId following induction therapy with Rituxan, the current standard of care.

The company has received fast-track designation from the FDA for FavId.

Favrille is a San Diego biopharmaceutical company focused on targeted immunotherapies to treat cancer and immune system diseases.

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