Positive XOMA 052 Results in Inflammatory Eye Disease - Behcet's Uveitis - Presented at American College of Rheumatology Scientific Meeting
BERKELEY, Calif., Nov. 10, 2010 (GLOBE NEWSWIRE) -- XOMA Ltd. (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, announced additional positive results from an open-label pilot study of XOMA 052 in patients with uveitis of Behcet's disease who were suffering from vision-threatening exacerbations despite maximal doses of immunosuppressive medicines. XOMA 052, a therapeutic antibody designed to inhibit the inflammatory cytokine interleukin-1 beta (IL-1 beta) is designated as an orphan drug for the treatment of Behcet's disease by the U.S. Food and Drug Administration and the European Medicines Agency. The new data presented at the 2010 American College of Rheumatology Scientific meeting include effects of XOMA 052 retreatment on uveitis exacerbations and analysis of serum cytokine levels.
As previously reported, all seven patients with Behcet's disease enrolled in the XOMA 052 trial displayed rapid reduction of intraocular inflammation and improvement in visual acuity or other ophthalmic measures following a single treatment with XOMA 052. The new results demonstrated that each of the five patients re-treated with XOMA 052 due to a recurring uveitis exacerbation responded again to XOMA 052 treatment and maintained their response for several months. Further, cytokine data showed, as compared to baseline, reduced levels of IL-1 beta, IL-1 alpha and IL-6 and increased levels of interferon gamma. The increase in interferon gamma is important because of the protective effects of this cytokine against infection.
Presentation information: Safe, Rapid-Onset and Sustained Biological Activity of IL-1 beta Regulating Antibody XOMA 052 in Resistant Uveitis of Behcet's Disease: Results of a Pilot Trial; Abstract # 1308, American College of Rheumatology
About Behcet's Disease and Behcet's Uveitis
Behcet's (pronounced beh-CHETS) disease is an orphan disease that causes chronic inflammation of the blood vessels, or vasculitis. Major symptoms can affect the neurological, pulmonary, gastrointestinal and cardiovascular systems, and hallmarks of the disease include painful ulcers in the mouth and on the genitals. Behcet's disease most commonly affects men and women in their twenties, thirties and forties, and it is typically more severe in men. Behcet's disease is also referred to as the "Silk Road" disease because it is most common among people from countries along this ancient trade route, including Turkey, eastern Mediterranean countries, Japan and Korea. An estimated 5,000 to 15,000 patients in the United States have Behcet's disease.
Uveitis, or inflammation of the intraocular tissues of the eye, of Behcet's disease is one of the most severe forms of uveitis and affects approximately half of the patients with Behcet's disease. Unlike many forms of chronic uveitis, Behcet's uveitis is characterized by recurrent acute attacks or exacerbations. Without immediate treatment, major exacerbations of Behcet's uveitis may lead to retinal detachment, vitreous hemorrhage, glaucoma and eventual blindness. Symptoms include the accumulation of vitreous haze which can block eyesight or the loss of visual acuity and can manifest differently from patient to patient. For example, patients may go from 20/20 eyesight to loss of vision during the course of an exacerbation. Available treatments for Behcet's uveitis are limited to corticosteroids and off-label use of immunosuppressive drugs, which can have significant side effects especially when used on a chronic basis.
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 diseases including Type 2 diabetes, cardiovascular disease, rheumatoid arthritis, gout, and auto-inflammatory diseases. IL-1 is a well-validated therapeutic target, with three marketed IL-1 inhibitors that have been used by more than 200,000 patients overall. By binding to IL-1 beta, XOMA 052 inhibits the activation of the IL-1 receptor, thereby preventing the cellular signaling events that produce inflammation.
XOMA is conducting two Phase 2 clinical trials of XOMA 052 in patients with Type 2 diabetes and a Phase 2 trial in Type 1 diabetes. The Phase 2 trials follow a successful 98 patient Phase 1 program in Type 2 diabetes patients in which XOMA 052 was shown to be well-tolerated, demonstrated evidence of biological activity in diabetes measures and cardiovascular biomarkers, and had a half-life that may provide convenient dosing of once per month or less frequently. The company has also demonstrated the potential for XOMA 052 in in vivo models of atherosclerosis and cardiac remodeling and in an in vitro model using human myeloma, or plasma cell cancer, cells.
About XOMA
XOMA discovers, develops and manufactures novel antibody therapeutics for its own proprietary pipeline as well as through license and collaborative agreements with pharmaceutical and biotechnology companies, and under its contracts with the U.S. government. The company's proprietary product pipeline includes:
XOMA 052, an anti-IL-1 beta antibody in Phase 2 clinical development for Type 2 diabetes, Type 1 diabetes and cardiovascular disease, with potential for the treatment of a wide range of inflammatory conditions. XOMA 3AB, an antibody candidate in pre-IND studies to neutralize the botulinum toxin, among the most deadly potential bioterror threats, under development through funding provided by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health (Contract # HHSN266200600008C). A preclinical pipeline with candidates in development for several diseases.
In addition to its proprietary pipeline, XOMA develops products with premier pharmaceutical companies including Novartis AG, Schering Corporation, a subsidiary of Merck & Co., Inc. and Takeda Pharmaceutical Company Limited.
XOMA's technologies 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 rheumatoid arthritis and Crohn's disease.
The company has a premier antibody discovery and development platform that incorporates an unmatched collection of antibody phage display libraries and proprietary Human Engineering(TM), affinity maturation, Bacterial Cell Expression (BCE) and manufacturing technologies. BCE 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, and several licensed product candidates are in clinical development.
XOMA has a fully integrated product development infrastructure, extending from pre-clinical science to approval, and a team of about 225 employees at its Berkeley, California location. For more information, please visit http://www.xoma.com.
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Safe Harbor Statement
Certain statements contained herein concerning clinical trial results and 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, results of early-stage clinical trials may not be supported by later findings, and larger trials and/or other actions required for regulatory approval may not be economically feasible.
These and other risks, including those related to the generally unstable nature of current economic conditions; the results of discovery research and preclinical 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 and licensing relationships; the ability of collaborators, licensees and other third parties 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.
CONTACT: XOMA Ltd.
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Released November 10, 2010