XOMA Issued New U.S. Patent Covering Its XOMA 052 Lead Product Candidate
XOMA 052 Targets the Inflammatory Cause of Type 2 Diabetes
BERKELEY, Calif., May 12, 2009 (GLOBE NEWSWIRE) -- XOMA Ltd. (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, announced that the U.S. Patent and Trademark Office today issued U.S. Patent No. 7,531,166, covering XOMA 052, and other antibodies and antibody fragments with similar binding properties for human interleukin-1 beta (IL-1 beta). IL-1 beta is 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, XOMA 052 inhibits the activation of the IL-1 receptor, thereby preventing the cellular signaling events that produce inflammation.
"This new patent provides coverage into the year 2027 and is the first patent to issue from a series of patent applications expected to cover our unique intellectual property position. It also highlights our pioneering role in the IL-1 beta antibody field where XOMA 052 may provide therapeutic benefit in multiple diseases," said Steven Engle, XOMA Chairman and Chief Executive Officer.
XOMA recently completed enrollment in Phase 1 trials for XOMA 052 in nearly 100 Type 2 diabetes patients and anticipates announcing top-line data from the U.S. trial in July. The trials were designed to evaluate a wide range of XOMA 052 doses, single and multiple dose regimens, and intravenous and subcutaneous routes of administration. Interim results from the single dose intravenous trials presented last autumn 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) as compared to placebo. Elevated CRP is an established marker for the systemic inflammation associated with increased cardiovascular risk.
These interim results support the potential for XOMA 052 as a novel anti-inflammatory approach to diabetes treatment. XOMA plans to initiate a multicenter, randomized, placebo-controlled Phase 2 trial in Type 2 diabetes in the third quarter of 2009.
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.
XOMA discovers, develops and manufactures therapeutic antibody therapeutics 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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Certain statements contained herein concerning plans to initiate a XOMA 052 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 initiation of a Phase 2 clinical trial 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.
CONTACT: XOMA Ltd. Company and Investor Contact: Carol DeGuzman 510-204-7270 email@example.com Porter Novelli Life Sciences Media Contact: Carolyn Hawley 619-849-5375 firstname.lastname@example.org
Released May 12, 2009