ZymoGenetics, Inc. (NASDAQ:ZGEN) today announced that the company has begun treating patients in a Phase 2 safety and efficacy study of Interleukin 21 (IL-21) in previously untreated patients with metastatic melanoma. The study is being run by the National Cancer Institute of Canada Clinical Trials Group at Queen’s University located in Kingston, Ontario.
“There’s a great need for effective treatments for advanced stage melanoma,” said Nicole Onetto, M.D., Senior Vice President and Chief Medical Officer of ZymoGenetics. “Our Phase 1 data suggests that IL-21 could be effective in treating metastatic melanoma. In this Phase 2 study, we’ll investigate IL-21 treatment further by administering the maximum dose that can be tolerated in the outpatient setting.”
The primary endpoint of the open label multi-center Phase 2 study is the objective tumor response or lack of early disease progression. The trial is expected to enroll approximately 30 patients at a dose of 50 mcg/kg.
Previous IL-21 studies
Previous clinical studies with IL-21 alone have shown that IL-21 is an active cytokine that can be administered in an outpatient regimen. Results from a Phase 1 study presented at the American Society of Clinical Oncology (ASCO) 2006 annual meeting showed that IL-21 administration was tolerable in an outpatient setting and reductions in tumor size were observed in several patients. Available clinical data support further clinical investigation of IL-21 as a new therapeutic agent for the treatment of cancer.
About Interleukin 21 (IL-21)
Endogenous IL-21 has potent biological activity in regulating key classes of immune cells, including cytotoxic T cells and natural killer cells. These cell types play important roles in eliminating malignant and infected cells. Based upon the ability of IL-21 to inhibit tumor growth in a number of animal models, ZymoGenetics is developing a recombinant form of IL-21 for the treatment of cancer, initially in metastatic melanoma and renal cell carcinoma and has retained commercialization rights for IL-21 in North America. The company licensed commercialization rights outside of North America to Novo Nordisk A/S.
About ZymoGenetics
ZymoGenetics creates novel protein drugs with the potential to significantly help patients fight their diseases. The company is developing a diverse pipeline of product candidates that are moving into and through clinical development. These candidates span a wide array of clinical opportunities that include bleeding, autoimmune and viral diseases and cancer. ZymoGenetics intends to commercialize these product candidates through internal development, collaborations with partners, and out-licensing of patents from its extensive patent portfolio. For further information, visit www.zymogenetics.com.