ZymoGenetics Begins Phase 2 Trial in Renal Cell Cancer Evaluating IL-21 Combined with Nexavar(R)
- Category: Proteins and Peptides
- Published on Wednesday, 09 January 2008 10:23
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ZymoGenetics, Inc. today announced that the company has initiated Phase 2 testing of Interleukin 21 in combination with Nexavar(R) tablets in patients with advanced renal cell cancer
SEATTLE, WA, USA | January 8, 2008 | ZymoGenetics, Inc. (NASDAQ:ZGEN) today announced that the company has initiated Phase 2 testing of Interleukin 21 (IL-21) in combination with Nexavar(R) (sorafenib) tablets in patients with advanced renal cell cancer. The Phase 2 study is part of a Phase 1/2 clinical trial and will examine patients treated with the maximum tolerated dose identified in the recently completed Phase 1 dose escalation phase.
"We're encouraged by the results of the Phase 1 portion of this trial and are convinced that IL-21 in combination with Nexavar deserves further evaluation in renal cell cancer," said Nicole Onetto, M.D., Senior Vice President and Chief Medical Officer of ZymoGenetics. "In Phase 2, we'll continue to evaluate the tolerability and anti-tumor activity of this combination therapy in patients with late stage renal cell cancer."
The primary objective of the open label multi-center Phase 2 study is to characterize safety of IL-21 with Nexavar at the recommended dose; a secondary objective is to evaluate anti-tumor activity, which will be assessed by evaluating tumor response and progression free survival. The trial is expected to enroll approximately 30 patients. The study is evaluating the combination in patients with clear cell carcinoma, which accounts for 85% of all renal cell tumors.
Results from the Phase 1 Trial with IL-21 and Nexavar
Interim results from the Phase 1 trial of IL-21 in combination with Nexavar in patients with renal cell cancer were presented in October 2007 at the AACR-NCI-EORTC International Conference. That data indicated that the combination of IL-21 and Nexavar is well tolerated, with a toxicity profile similar to known toxicities of each agent alone. Preliminary evidence of anti-tumor activity was also documented in the majority of the patients treated in Phase 1.
Renal Cell Cancer
There will be an estimated 51,190 new cases of renal cell carcinoma in the U.S. in 2007. It is estimated that renal cell carcinoma will result in approximately 19,600 deaths in the U.S. in 2007. Renal cell carcinoma accounts for approximately 2% of cancers world wide. There is a clear need for new and improved therapies for renal cell cancer.
IL-21 in Combination with Tyrosine Kinase Inhibitors
Because tyrosine kinase inhibitors (TKIs) such as Nexavar and Sutent(R) (Sunitinib) inhibit the growth of tumor cells and act on the underlying vasculature, and IL-21 activates the immune system to target killing of tumor cells, the two therapies may provide additive effects. Treatment with a TKI may make cancer cells more sensitive to natural killer or T cell mediated killing after activation with IL-21. Preclinical research conducted by ZymoGenetics of TKIs and IL-21 found that IL-21 had additive anti-tumor effects when combined with a TKI in a renal cell cancer model.
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.
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.
Nexavar(R) (sorafenib) tablets is a registered trademark of Bayer HealthCare Pharmaceuticals, Inc.
SOURCE: ZymoGenetics, Inc.