CD4CAR therapy receives FDA approval for orphan drug designation for peripheral T-cell Lymphoma

Release Date: 20-Nov-2016

FDA granted orphan drug designation to icell gene therapeutics for its chimeric antigen receptor-engineered T cells directed against the target protein CD4 to treat peripheral T-cell Lymphoma. These chimeric antigens are made up of patient’s own T-cells that are genetically modified to express a protein on its surface.


Action of mechanism of CD4CAR includes by binding to a target protein on another cell and the CAR protein sends a signal to the interior of the T cell to unleash mechanisms that selectively kill the targeted cell.


The FDA Orphan Drug Designation is granted to medicines and biologics that are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment medicine.


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