BERKELEY, Calif., April 30, 2009 (GLOBE NEWSWIRE) -- XOMA Ltd. (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, today announced that it has completed patient enrollment in its Phase 1 clinical development program for XOMA 052, a drug candidate that targets the inflammatory cause of Type 2 diabetes. The company plans to provide preliminary "top line" results from the Phase 1 studies in July 2009.
"We have made excellent progress in advancing XOMA 052. These studies provide more than the usual Phase 1 results -- they include evidence of biological activity as well as safety and pharmacokinetic data," said Steven B. Engle, Chairman and Chief Executive Officer of XOMA. "Based on the Phase 1 program, XOMA plans to initiate a multicenter, randomized, placebo-controlled Phase 2 program in Type 2 diabetes in the third quarter of 2009."
Nearly 100 patients were enrolled in Phase 1 trials in the U.S. and Switzerland. The U.S. trial has three parts: a dose-escalation part evaluating a single dose of XOMA 052 or placebo administered intravenously (IV); a dose-escalation part evaluating a single dose of XOMA 052 or placebo administered subcutaneously (SC); and a dose-escalation part evaluating XOMA 052 or placebo administered SC once every two weeks for three doses. The Swiss trial is a dose-escalation trial evaluating a single IV dose of XOMA 052 or placebo. It was conducted at an academic center which performed specialized assessments of insulin production in participating patients.
Positive interim results from the single dose IV studies were presented in September 2008 at the European Association for the Study of Diabetes annual meeting. The results demonstrated that XOMA 052 was well-tolerated across all doses and demonstrated biological activity, including reduced levels of glycosylated hemoglobin, increased insulin production and decreased levels of C-reactive protein (CRP), supporting its potential as a novel anti-inflammatory approach to diabetes treatment. Elevated CRP is an established marker for the systemic inflammation associated with increased cardiovascular risk.
"XOMA 052 represents a novel approach to diabetes treatment which targets the inflammatory process in Type 2 diabetes. It has the potential for improved glycemic control and reduced CRP levels based on its mechanism of action," said Patrick J. Scannon, M.D., Ph.D., XOMA's Executive Vice President and Chief Medical Officer. "XOMA 052's encouraging results so far in CRP reduction in Type 2 diabetes patients expands our foundation for the development of this molecule. The availability of a well-tolerated agent that could address both glycemic control and cardiovascular protection would provide a significant and new approach in the management of Type 2 diabetes."
About XOMA 052
XOMA 052 is a potent monoclonal antibody with the potential to improve the treatment of patients with a wide variety of inflammatory diseases. XOMA 052 binds strongly to interleukin-1 beta (IL-1 beta), a pro-inflammatory cytokine involved in the development of Type 2 diabetes, cardiovascular disease, rheumatoid arthritis, gout and other diseases. By binding to IL-1 beta, the drug inhibits the activation of the IL-1 receptor, thereby preventing the cellular signaling events that produce inflammation. XOMA 052 has a half-life of 22 days. Based on its binding properties, specificity to IL-1 beta and half-life, XOMA 052 may provide convenient dosing of once per month or less frequently.
XOMA developed XOMA 052 using the company's proprietary antibody technologies, capabilities and expertise. XOMA owns worldwide rights to the antibody and related intellectual property. The company is actively pursuing a partnership for the development and commercialization of XOMA 052.
The central role of the IL-1 pathway in multiple diseases has been clinically validated by two FDA-approved therapies and several inhibitors of the inflammatory IL-1 pathway in clinical development. These disease indications include rheumatoid arthritis, systemic juvenile idiopathic arthritis, gout, Muckle-Wells syndrome, and others.
About XOMA
XOMA discovers, develops and manufactures therapeutic antibody and other agents designed to treat inflammatory, autoimmune, infectious and cancerous diseases. The company's proprietary product pipeline includes XOMA 052, an anti-IL-1 beta antibody, and XOMA 3AB, a biodefense anti-botulism antibody candidate.
XOMA's proprietary development pipeline is primarily funded by multiple revenue streams resulting from the licensing of its antibody technologies, product royalties, development collaborations and biodefense contracts. XOMA's technologies and experienced team have contributed to the success of marketed antibody products, including LUCENTIS(r) (ranibizumab injection) for wet age-related macular degeneration and CIMZIA(r) (certolizumab pegol) for Crohn's disease.
The company has a premier antibody discovery and development platform that incorporates leading antibody phage display libraries and XOMA's proprietary Human Engineering(tm) and Bacterial Cell Expression and manufacturing technologies. Bacterial Cell Expression is a key breakthrough biotechnology for the discovery and manufacturing of antibodies and other proteins. As a result, more than 50 pharmaceutical and biotechnology companies have signed BCE licenses.
In addition to developing its own products, XOMA develops products with premier pharmaceutical companies including Novartis AG, Schering-Plough Research Institute and Takeda Pharmaceutical Company Limited. XOMA has a fully integrated product development infrastructure, extending from pre-clinical science to approval, and a team of about 200 employees at its Berkeley location. For more information, please visit http://www.xoma.com.
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Forward-Looking Statements
Certain statements contained herein concerning the company's pursuit of a development and commercialization partner for its XOMA 052 product candidate, plans to initiate a Phase 2 clinical program, timing of availability of results of clinical trials and/or other aspects of product development or that otherwise relate to future periods are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements are based on assumptions that may not prove accurate. Actual results could differ materially from those anticipated due to certain risks inherent in the biotechnology industry and for companies engaged in the development of new products in a regulated market.
Among other things, the company's ability to enter into a partnership with respect to XOMA 052 will depend on potential partners' level of interest in the product, assessment of the company as a potential partner and availability of resources, and the initiation of a Phase 2 clinical program and/or the timing of availability of results of clinical trials may be delayed or may never occur as a result of unavailability of resources, actions or inaction by our present or future collaboration partners, or unanticipated safety issues.
These and other risks, including those related to XOMA's ability to remain in compliance with or renegotiate the requirements of its loan agreements; the declining and generally unstable nature of current economic conditions; the results of discovery and pre-clinical testing; the timing or results of pending and future clinical trials (including the design and progress of clinical trials; safety and efficacy of the products being tested; action, inaction or delay by the FDA, European or other regulators or their advisory bodies; and analysis or interpretation by, or submission to, these entities or others of scientific data); changes in the status of existing collaborative relationships; the ability of collaborators and other partners to meet their obligations; XOMA's ability to meet the demands of the United States government agency with which it has entered into its government contracts; competition; market demands for products; scale-up and marketing capabilities; availability of additional licensing or collaboration opportunities; international operations; share price volatility; XOMA's financing needs and opportunities; uncertainties regarding the status of biotechnology patents; uncertainties as to the costs of protecting intellectual property; and risks associated with XOMA's status as a Bermuda company, are described in more detail in XOMA's most recent filing on Form 10-K and in other SEC filings. Consider such risks carefully when considering XOMA's prospects.