FDA GRANTS ORPHAN DRUG DESIGNATION TO ZYMOGENETICS' IL-21

The FDA has granted orphan drug designation to ZymoGenetics' Interleukin 21 (IL-21) for the treatment of melanoma patients with advanced or aggressive disease. ZymoGenetics is testing IL-21 in an ongoing Phase Ib clinical trial in melanoma and renal cell carcinoma with a dosing regimen administered in an outpatient setting.

IL-21 is a novel cytokine with potent effects on a number of immune effector cells such as cytotoxic T cells and natural killer cells. These cell types are thought to play key roles in eliminating malignant and infected cells from the body.

Metastatic melanoma and renal cell carcinoma, two tumors that have been shown to be responsive to immune based therapies, were selected as the initial indications. In addition, IL-21 has been shown to inhibit tumor growth in animal models of melanoma and renal cell carcinoma with a mechanism involving regulation of immune cells.