FDA grants Orphan Drug Designation to CD4CAR therapy for treatment of peripheral T-cell lymphoma

iCell Gene Therapeutics today (Aug. 11) announced that the Food and Drug Administration has granted Orphan Drug Designation for its chimeric antigen receptor engineered T-cells directed against the target protein CD4 (CD4CAR) for the treatment of peripheral T-cell lymphoma (PTCL).

William Tse, M.D., chief of the Blood and Marrow Transplantation Division, Department of Medicine at the University of Louisville School of Medicine, said "We are very excited to have this opportunity to partner with iCell Gene Therapeutics to lead the efforts of preparing this cutting-edge immunotherapy into first-in-human clinical trial for patients suffering this extremely difficult-to-treat T-cell lymphoma."

The Orphan Drug Designation program provides orphan status and associated development incentives, to drugs and biologics intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States.

Yupo Ma, M.D., Ph.D., professor of pathology at Stony Brook University and chairman and chief scientific officer at iCell Gene Therapeutics, said, "CD4CAR could significantly enhance currently available treatment options for these patients. The Orphan Drug Designation is an important achievement as we advance our development plans for this promising treatment in T-cell hematologic cancers."

Source: University of Louisville

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