SEATTLE, Jan. 10 /PRNewswire-FirstCall/ -- ZymoGenetics, Inc. announced preliminary results today from a randomized, placebo-controlled double-blind Phase 1b clinical trial of TACI-Ig in rheumatoid arthritis (RA) patients.
“The results of this study are very encouraging,” said Nicole Onetto, M.D., Senior Vice President and Chief Medical Officer of ZymoGenetics. “The clear biologic effects and excellent safety profile we have seen with TACI-Ig as well as the correlations between dose/schedule and biological activity will help us to optimize the design of future studies in RA and other diseases.”
The primary objective of this study, conducted by partners ZymoGenetics and Serono S.A., was to determine the safety and tolerability of TACI-Ig in rheumatoid arthritis (RA) patients and to examine the relationship between TACI-Ig dose and schedule with markers of biologic activity and disease activity. TACI-Ig appeared to be safe and well tolerated across the full range of dose levels and schedules tested in this study, and clear biologic responses were observed, which appeared to correlate with clinical benefit. Full details from this study will be presented at a medical meeting later in the year.
The trial enrolled a total of seventy-three adult male and female patients with moderate to severe RA after failure of other non-biologic therapies. Patients received single or multiple doses of either TACI-Ig or placebo for a maximum period of three months. The predominant adverse event noted was a mild injection site reaction (redness of skin or pain at injection site). No antibodies to TACI-Ig were formed in any patient receiving TACI-Ig treatment. All patients were monitored during and for several weeks after dosing to assure safety.
Also observed in patients treated with TACI-Ig were schedule and dose-dependent reductions of IgM, IgA and IgG and of rheumatoid factor, a biologic marker of disease. In the cohort of 19 patients that received seven doses of TACI-Ig over a three-month period, positive trends on some disease activity measures such as ACR 20 and DAS 28 were also noted.
About TACI-Ig
ZymoGenetics is developing TACI-Ig for the treatment of autoimmune diseases and B-cell malignancies. 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 clinical 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 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 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.
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: investors, John Calhoun, MD, MBA, Director, CorporateCommunications & Investor Relations, +1-206-442-6744, or media, Susan W.Specht, MBA, Corporate Communications Manager, +1-206-442-6592, both ofZymoGenetics
Web site: http://www.zymogenetics.com/
