SEATTLE, July 12 /PRNewswire-FirstCall/ -- ZymoGenetics, Inc. today announced that a Phase 1 clinical trial is underway using Interleukin 21 (IL-21) in combination with the monoclonal antibody Rituxan(R). The open label dose-escalation trial is enrolling patients with advanced non- Hodgkin's lymphoma in a multi-site study conducted in the U.S. Patients will be treated with Rituxan and IL-21 once weekly for four weeks. Responding patients will be offered the combination regimen for four additional weeks.
"Patients need better treatments to fight cancer," said Bruce L. A. Carter, Ph.D., President and Chief Executive Officer of ZymoGenetics. "We believe IL-21 in combination with Rituxan could offer an improvement over current therapies because in preclinical studies, IL-21 enhanced natural killer cell activity and improved monoclonal antibody anti-tumor activity."
The primary objective of the study is to evaluate the safety and tolerability of IL-21 when administered with Rituxan. Secondary objectives are to characterize the pharmacokinetics, immunogenicity and preliminary evidence of tumor activity of this combination.
Preclinical research into this combination offers compelling evidence for entering clinical trials, largely because IL-21 appears to enhance a principal mechanism by which Rituxan is thought to work. At ASH 2005, ZymoGenetics presented the results of preclinical research on IL-21's ability to enhance Rituxan-mediated killing of B-lymphoma cell lines. In these studies, after 90 days of follow-up, a combination of IL-21 plus low-dose Rituxan enabled survival of 70% of mice injected with an aggressive non-Hodgkin's lymphoma cell line, compared with only 10% that were treated with the same dose of Rituxan alone, and none that were treated with IL-21 alone.
About Interleukin 21 (IL-21)
Interleukin 21 (IL-21) has potent biological activity in regulating key classes of immune cells, including cytotoxic T cells and NK cells. These cell types play key roles in surveillance of the body to eliminate malignant and infected cells. Based upon the ability of IL-21 to inhibit tumor growth in a number of animal models, ZymoGenetics is developing IL-21 for the treatment of cancer and has retained commercialization rights for IL-21 in North America. The company has 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 potential proprietary product candidates that are moving into and through clinical development. These candidates span a wide array of clinical opportunities that include bleeding, autoimmune 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, 2005. 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.
Contact Investor Relations John Calhoun, MD, MBA Director, Corporate Communications & Investor Relations 206-442-6744 Media Relations Susan W. Specht, MBA Associate Director, Corporate Communications 206-442-6592
ZymoGenetics, Inc.CONTACT: Investor Relations, John Calhoun, MD, MBA, Director, CorporateCommunications & Investor Relations, +1-206-442-6744, or Media Relations,Susan W. Specht, MBA, Associate Director, Corporate Communications,+1-206-442-6592, both of ZymoGenetics, Inc.
Web site: http://www.zymogenetics.com//
