SEATTLE, Dec. 8 /PRNewswire-FirstCall/ -- ZymoGenetics, Inc. provided updates on its research and development programs at an Analyst & Investor Briefing held today in New York City. Highlights of the meeting follow. An archived webcast of the ZymoGenetics Analyst and Investor Briefing may be accessed at www.zymogenetics.com.
“ZymoGenetics’ clinical trials continue to progress as planned,” said Bruce L.A. Carter, Ph.D., President and Chief Executive Officer of ZymoGenetics. “Our pivotal Phase 3 study of rhThrombin in surgical bleeding is underway, and we expect to submit results to the FDA by the end of next year. In addition, studies with IL-21 and TACI-Ig, potential treatments for cancer and autoimmune disease, are on track. We’re looking forward to the opportunities our product candidates may present for patients who need new and innovative therapies.”
Highlights Company highlights discussed at the meeting include the following: -- ZymoGenetics’ three product candidates in clinical trials are: -- Recombinant human thrombin (rhThrombin) for control of surgical bleeding -- TACI-Ig for treatment of autoimmune diseases and B-cell malignancies -- Interleukin 21 (IL-21) for treatment of cancer. -- The company is conducting a pivotal Phase 3 clinical trial comparing rhThrombin to bovine thrombin (the currently marketed product) in four surgical settings. The study will enroll 400 - 600 patients and is designed to compare the safety, efficacy and immunogenicity of the two products. ZymoGenetics plans to submit a Biologics Licensing Application for rhThrombin to the FDA in late 2006. -- Guest speaker Jeffrey H. Lawson, M.D., Ph.D. discussed the use of thrombin in surgery and risks associated with the currently marketed bovine thrombin product. Dr. Lawson is a faculty member of the Departments of Surgery and Pathology at Duke University Medical Center in Durham, North Carolina and has extensively studied the immunogenicity of bovine thrombin and the relationship to post-surgical complications. -- A review of the market for thrombin shows rapid growth of the market in recent years. The company presented the results of market research, showing the potential for rapid conversion of the existing bovine thrombin market to rhThrombin. Current market statistics indicate a relatively concentrated customer base for thrombin. Accordingly, ZymoGenetics is planning to build a sales force of up to 50 individuals to target these key institutions for conversion. -- ZymoGenetics and partner Serono continue to conduct clinical trials with TACI-Ig in autoimmune diseases and advanced B-cell cancers. The companies recently completed a Phase 1b study of patients with rheumatoid arthritis (RA), and are analyzing the results. ZymoGenetics and Serono plan to present the RA top-line study results in early 2006 and the full study results at a scientific meeting in the first half of 2006. A trial in systemic lupus erythematosus (SLE) patients is expected to finish in the first half of 2006, with top-line results to be presented in mid 2006 and full study results at a scientific meeting in the second half of 2006. Interim Phase 1 trial results of TACI-Ig as a therapy for B-cell malignancies will be presented at next week’s ASH 2005 meeting. In the course of treating individuals in Phase 1 studies, the companies gained a significant understanding of the relationship between dose regimen and biological effect and are using the information to establish dosing schedules to be tested in future clinical trials. The companies plan to initiate Phase 2 studies in the second half of 2006, after analysis of the Phase 1 trials is completed. -- ZymoGenetics recently completed and presented results from Part A of a Phase 1 study with IL-21 as a potential outpatient treatment for patients with metastatic melanoma and renal cell carcinoma. The primary objective of this study was to determine the maximum tolerated dose of IL-21 through a series of escalating doses in small groups of patients. However, evidence of anti-tumor activity was observed in some of the fifteen patients treated, as tumor size remained stable in eight patients, and was reduced by more than thirty percent in two others. IL-21 was reasonably well tolerated, and a maximum tolerated dose of thirty micrograms per kilogram of body weight was selected for further study. Through treatment of up to 24 additional patients (12 patients each with metastatic melanoma and renal cell carcinoma) in Part B of the study, ZymoGenetics plans to characterize the safety and clinical effectiveness of an outpatient dosing regimen consisting of two cycles of five daily doses at the established dose level. The company plans to submit further data for presentation at the 2006 American Society of Clinical Oncology annual meeting in Atlanta, Georgia. In IL-21 Phase 2 clinical studies, ZymoGenetics is planning to examine renal cell cancer and Novo Nordisk will evaluate metastatic melanoma. -- The company expects to file an Investigational New Drug application amendment later this month relating to the study of IL-21 in combination with the monoclonal antibody Rituxan(R), with plans to start clinical trials in 2006. Preclinical research into this combination offers compelling evidence for entering clinical trials, largely because IL-21 has been shown in preclinical studies to activate several cell types involved in the anti-cancer mechanism of Rituxan(R). A presentation at ASH 2005 will further discuss the findings of preclinical studies with this combination. -- Interleukin-29 (IL-29) was established as a development candidate in 2005, initially focused on the treatment of chronic Hepatitis C infection. The company is conducting preclinical studies and manufacturing drug supply for clinical trials planned to begin in 2006. IL-29 is being manufactured in ZymoGenetics’ pilot scale manufacturing facility in Seattle, Washington.
Anyone interested in enrolling in clinical trials with rhThrombin, TACI-Ig or IL-21 should contact: clinicaltrials@zgi.com.
Overview of Product Candidates
About rhThrombin
ZymoGenetics is developing rhThrombin for the control of bleeding associated with surgical procedures. Thrombin is used in over 700,000 surgeries per year in the United States. Currently, only thrombin derived from cow blood is available in the U.S. as a stand-alone thrombin product. Bovine-derived thrombin has been associated with the development of antibodies that may cross-react with human blood proteins. In some cases, these antibodies lead to serious bleeding complications. Recombinant proteins, such as rhThrombin, can be manufactured to higher levels of purity and consistency than proteins purified from human or animal blood. Furthermore, the production of recombinant proteins is not dependent on the availability of blood from human or animal donors and can be scaled-up to meet market demands. For these reasons, ZymoGenetics believes that rhThrombin represents a potential preferred alternative to the bovine-derived product.
About TACI-Ig
ZymoGenetics is developing TACI-Ig for the treatment of autoimmune diseases. TACI-Ig is a soluble receptor that binds to BLyS and APRIL, TNF family cytokines that promote B-cell survival and the production of harmful autoantibodies, which cause certain autoimmune diseases such as systemic lupus erythematosus (SLE). Preclinical data indicate that levels of BLyS and APRIL are elevated in patients with rheumatoid arthritis, SLE and B-cell malignancies. TACI-Ig has been shown to affect several stages of B-cell development and may inhibit the survival of cells responsible for making antibodies. ZymoGenetics is developing TACI-Ig in collaboration with Serono S.A. and is conducting Phase 1b studies in patients with SLE, rheumatoid arthritis and advanced B-cell malignancies, such as multiple myeloma, B-cell non-Hodgkin’s lymphoma and chronic lymphocytic leukemia.
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 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 Interleukin 29 (IL-29)
Interleukin 29 (IL-29) is being developed by ZymoGenetics as a potential treatment for patients infected with hepatitis C. IL-29 is generated in response to viral infection and preclinical data has shown anti-viral activity comparable to that of alpha-interferon. However, IL-29 signals through a receptor that is distinct from and with a more restricted expression pattern throughout the body than the receptors for type I interferons, suggesting that IL-29 may serve as an alternative to interferons in providing immunity to viral infection. ZymoGenetics plans to file an Investigational New Drug application in 2006 for IL-29 as a treatment for hepatitis C infection.
About Interleukin 31 (IL-31)
ZymoGenetics researchers discovered Interleukin 31 (IL-31) using the company’s genomics-based discovery platform. Current in vitro and in vivo data suggest that IL-31 may affect cellular infiltration and inflammation. Analysis of IL-31 and IL-31 receptor levels in human and murine disease tissues suggests that expression of IL-31, and/or its receptor, is significantly increased in the settings of atopic dermatitis, inflammatory bowel disease and psoriasis. A paper by ZymoGenetics scientists published in the July 2004 issue of the journal Nature Immunology characterizes IL-31, illustrates the hypothesized role of IL-31 in atopic dermatitis and suggests directions for future investigation of this cytokine and its role in human diseases.
About ZymoGenetics
ZymoGenetics is a biopharmaceutical company focused on the discovery, development and commercialization of therapeutic proteins for the prevention or treatment of human 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, 2004. 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 Corporate Communications Manager (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, Corporate Communications Manager, +1-206-442-6592,both of ZymoGenetics, Inc.
Web site: http://www.zymogenetics.com/
