ZymoGenetics Begins Phase 2 Clinical Trial of IL-21 in Melanoma
- Category: Proteins and Peptides
- Published on Tuesday, 18 December 2007 23:20
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Collaboration with National Cancer Institute of Canada Clinical Trials Group
SEATTLE, WA, USA | December 18, 2007 | 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.
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.
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on the current intent and expectations of the management of ZymoGenetics. These statements are not guarantees of future performance and involve risks and uncertainties that are difficult to predict. ZymoGenetics' actual results and the timing and outcome of events may differ materially from those expressed in or implied by the forward-looking statements because of risks associated with our unproven discovery strategy, preclinical and clinical development, regulatory oversight, intellectual property claims and litigation and other risks detailed in the company's public filings with the Securities and Exchange Commission, including the company's Annual Report on Form 10-K for the year ended December 31, 2006. Except as required by law, ZymoGenetics undertakes no obligation to update any forward-looking or other statements in this press release, whether as a result of new information, future events or otherwise.
SOURCE: ZymoGenetics, Inc.