Guest guest Posted September 4, 2004 Report Share Posted September 4, 2004 ZymoGenetics Announces Start of TACI-Ig Clinical Study in Rheumatoid Arthritis; Second Phase 1b Study Initiated in Patients with Autoimmune Disease http://home.businesswire.com/ SEATTLE--Aug. 30, 2004--ZymoGenetics (Nasdaq:ZGEN) announced the start of a Phase 1b clinical study of TACI-Ig, in collaboration with Serono S.A., for patients with rheumatoid arthritis (RA). The study is designed to evaluate the safety and pharmacokinetics of escalating doses of TACI-Ig, while also monitoring its biological effects. Previously, ZymoGenetics and Serono started a Phase 1b study with TACI-Ig in lupus patients and also completed a Phase 1 study of TACI-Ig in healthy volunteers. The companies are committed to investigating other indications for TACI-Ig, such as B-cell disorders. " The role of B-cells in RA is becoming more well established, making RA a promising indication for TACI-Ig, " said Bruce L. A. , Ph.D., President and CEO of ZymoGenetics. " We see a number of interesting possibilities for TACI-Ig and we're leveraging our investment in the program by expanding into other areas besides lupus. RA represents a large potential market with well-defined clinical trial parameters for approval, and yet there are many patients who have not been helped by recent advances in therapeutic approaches. " The Phase 1b study in RA patients will assess the systemic and local tolerability of TACI-Ig in a single and repeat dose escalation placebo-controlled double-blind study. The secondary objective is to characterize the pharmacokinetics and pharmacodynamics of TACI-Ig and to monitor the effects on biological markers of disease activity. The study will be conducted by Serono in a total of 60 patients in Europe and Australia. About TACI-Ig TACI-Ig is a soluble fusion protein that links the extracellular portion of the TACI receptor to the Fc portion of human immunoglobulin (Ig). TACI 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 SLE. Preclinical data indicate that levels of BLyS and APRIL, as well as complexes containing both APRIL and BLyS, are elevated in RA. TACI-Ig has been shown to affect several stages of B-cell development and may inhibit the survival of cells responsible for making antibodies. In addition, because TACI-Ig blocks BLyS and APRIL, it has a different mechanism of action from anti-TNF agents. About RA Rheumatoid arthritis affects over two million Americans and more than five million people in Europe and Japan. It is a disabling autoimmune disease in which the joint lining and other organs become inflamed. Despite new therapies developed in recent years, an estimated 20% to 40% of RA patients do not respond to the current anti-TNF agents, leaving a large number of patients who do not respond to first line therapies seeking decreased disease progression and improved quality of life. Other agents with different mechanisms of action are needed to provide relief to these patients. The current market size is estimated to be $3 billion and is projected to grow to over $8 billion by 2010. ZymoGenetics and Serono Collaboration ZymoGenetics and Serono entered into an exclusive co-development and commercialization agreement in 2001 focused on the development of TACI-Ig. The two companies share research and development expenses worldwide, except for Japan, where Serono covers all expenses. ZymoGenetics intends to co-promote products with Serono in North America. The two companies will share commercialization expenses and profits equally in North America. ZymoGenetics receives a royalty in the rest of the world. Serono has exclusive rights to market TACI-Ig in the remainder of the world, for which ZymoGenetics is entitled to receive royalty payments. Serono is responsible for manufacturing the product for both clinical trials and commercial sale. 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 ZymoGenetics' public filings with the Securities and Exchange Commission, including ZymoGenetics' Annual Report on Form 10-K for the year ended December 31, 2003. 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. Quote Link to comment Share on other sites More sharing options...
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