SEATTLE, June 5 /PRNewswire-FirstCall/ -- ZymoGenetics, Inc. today announced that findings were presented from a completed Phase 1 clinical trial with Interleukin 21 (IL-21) in patients with stage IV metastatic melanoma and renal cell carcinoma at the American Society of Clinical Oncology (ASCO) 2006 annual meeting held in Atlanta, Georgia. IL-21 administration in an outpatient setting was associated with a satisfactory toxicity profile and with preliminary evidence of anti-tumor activity.
John A. Thompson, M.D., University of Washington, presented “Interleukin- 21 (IL-21) tolerability and anti-tumor activity following two 5-day cycles in patients with stage IV melanoma (MM) or renal cell carcinoma (RCC).” The open-label Phase 1 clinical trial was a two-part study. Part A evaluated dose escalation to determine maximum tolerated dose and Part B studied safety and tolerability at the dose level identified in Part A. Dr. Thompson’s ASCO presentation focused on 34 patients treated at the recommended dose of 30 mcg/kg, six of whom were treated in Part A of the study. Overall, there were 18 MM and 16 RCC patients treated at the recommended dose.
Patients were given two cycles of five consecutive daily doses of IL-21 with an intervening rest period. Nine patients received additional cycles of IL-21. IL-21 administration was associated with increases in the lymphocyte activation marker soluble CD25 and decreases in lymphocyte counts demonstrating clear pharmacologic effect on the immune system.
The safety profile of IL-21 observed in Part B of the study (dose of 30 mcg/kg) was similar to that of Part A, with three subjects experiencing Grade 3 adverse events related to IL-21 (abdominal pain, thrombocytopenia and hypophosphatemia). Part A adverse event findings were presented at the 2005 International Society of Biological Therapy of Cancer (ISBTc) meeting and showed that all but one adverse event was Grade 1 or 2 in severity. Common adverse events were flu-like symptoms and rash.
Evidence of anti-tumor activity was assessed by the RECIST criteria and revealed that in Part B of the study, one RCC patient achieved a partial response and one MM patient had a complete response. Additionally, 21 patients were classified as having stable disease following IL-21 treatment. Anti-tumor activity for Part A of the Phase 1 study, as reported at the 2005 ISBTc meeting, included two additional partial responses in RCC patients- one at 3 mcg/kg and one at 50 mcg/kg.
Overall, Dr. Thompson concluded that IL-21 is an active cytokine that can be administered in an outpatient regimen. The available clinical data support further clinical investigation of IL-21 as a new therapeutic agent for the treatment of cancer. ZymoGenetics is planning to start Phase 1/2 testing of IL-21 for RCC in combination with tyrosine kinase inhibitors in the second half of 2006. The company also expects to begin a study shortly combining IL-21 with rituximab in patients with non-Hodgkin’s lymphoma.
Abstract
The abstract will be available at www.zymogenetics.com in the “What’s New” section on the home page.
About Interleukin 21 (IL-21)
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 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, 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 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//
