XOMA Initiates Phase I U.S. Trial in Type 2 Diabetes for XOMA 052, Monoclonal Antibody With Therapeutic Potential in Multiple Inflammatory Diseases
Anti-IL-1 Beta Product Candidate Developed by XOMA Using XOMA's Integrated Antibody Discovery and Development Capabilities
BERKELEY, Calif., July 16, 2007 (PRIME NEWSWIRE) -- XOMA Ltd. (Nasdaq:XOMA) today announced the initiation of Phase I clinical testing of product candidate XOMA 052, a potent monoclonal antibody targeting Interleukin-1 beta (IL-1 beta), in patients with Type 2 diabetes. IL-1, which plays a role in multiple inflammatory diseases, has been implicated in the pathogenesis of diabetes through the destruction of the pancreatic islet cells that produce insulin.
This U.S.-based study, designed to assess the safety and pharmacokinetics of XOMA 052, will enroll up to 72 subjects with Type 2 diabetes. XOMA plans to initiate a European-based Phase I clinical trial of XOMA 052 in Type 2 diabetes patients later in 2007. Safety data from both trials are expected to guide the development of XOMA 052 for additional indications, which may include rheumatoid arthritis, systemic juvenile idiopathic arthritis, and osteoarthritis.
"Anti-IL-1 beta therapy has the potential to significantly advance the approach to diabetes care by altering the disease state itself," said Jack Castello, chairman of the board, president and chief executive officer of XOMA. "XOMA 052, developed by XOMA using XOMA's antibody discovery and Human Engineering technologies and capabilities, offers the promise of improved therapy for major medical needs. We are pleased to be able to advance XOMA 052 to the clinic and look forward to evaluating options for its broader clinical development."
XOMA is working with Charles A. Dinarello, M.D., Marc Y. Donath, M.D., and Thomas Mandrup-Polsen, M.D., Ph.D., leading researchers of Type 2 diabetes and IL-1 beta. Dr. Donath commented, "I expect XOMA 052, when administered to patients with Type 2 diabetes, to provide an effective inhibition of the IL-1 beta cytokine released by insulin producing islet cells. This inhibition may substantially block the progression of the disease."
About Interleukin-1 and Inflammatory Disease
IL-1 is a pro-inflammatory cytokine secreted by a number of cell types including monocytes and macrophages. The IL-1 gene family includes IL-1 beta , which is released from cells as part of an inflammatory reaction. IL-1 beta produces a range of biological effects, mainly through the induction of other pro-inflammatory mediators such as corticotrophin, platelet factor-4, prostaglandin E2 (PGE2), IL-6, and IL-8. IL-1 beta induces both local and systemic inflammatory effects through the activation of the IL-1 receptor found on almost all cell types. IL-1 beta is implicated in the pathogenesis of many disease states involving localized and systemic inflammation. Targeting this pathway and reducing the effects of IL-1 beta may provide clinical benefit in rheumatoid arthritis, systemic juvenile idiopathic arthritis, osteoarthritis, and other inflammatory diseases.
About Interleukin-1 and Type 2 Diabetes
There is evidence that blocking the IL-1 pathway has improved the control of blood glucose. In the presence of high blood glucose, IL-1 beta concentration in the pancreas increases. This increase in IL-1 beta is toxic to the insulin-producing pancreatic islet cells. Death of islet cells reduces the production of insulin to control blood glucose. Eventually this destructive cycle leads to all Type 2 diabetic patients requiring insulin therapy to compensate for their inability to produce insulin. It is hypothesized that blocking IL-1 beta may improve insulin production by breaking this cycle and preserving pancreatic islet cells.
About XOMA 052
XOMA 052 is a potent anti-inflammatory monoclonal antibody targeting IL-1 beta and is being developed as a modulator of cytokine imbalance in IL-1 mediated disease states. It is an IgG2 isotype, which reduces the possibility of antibody dependent cellular cytotoxicity. With its high binding affinity of 300 fM and expected long circulating half-life, XOMA 052 may offer many patient advantages. XOMA 052 was developed by XOMA from its extensive antibody discovery infrastructure, was humanized using XOMA's Human Engineering technology, and is fully owned by XOMA. XOMA plans additional clinical trials in Type 2 diabetes and is evaluating plans to expand the development of XOMA 052 into other inflammatory diseases including rheumatoid arthritis, systemic juvenile idiopathic arthritis, and osteoarthritis.
About Type 2 Diabetes
Type 2 Diabetes is a condition characterized by high blood glucose levels caused by either a lack of insulin or the body's inability to use insulin efficiently. Type 2 diabetes develops most often in middle-aged and older adults but can appear in young people. The Centers for Disease Control and Prevention estimate that approximately 20.8 million people in the U.S. had diabetes in 2005. Type 2 diabetes is the most common form of the disease, accounting for approximately 90 percent to 95 percent of all diagnosed cases. Type 2 diabetes can lead to serious complications and premature death. However, Type 2 diabetes can be prevented or delayed, and people with diabetes can take steps to control the disease and lower the risk of serious complications. For more information about Type 2 diabetes, visit www.cdc.gov/diabetes.
XOMA is a leader in the discovery, development and manufacture of therapeutic antibodies, with a therapeutic focus that includes cancer and immune diseases. XOMA has royalty interests in RAPTIVA(r) (efalizumab), a monoclonal antibody product marketed worldwide (by Genentech, Inc. and Merck Serono S.A.) to treat moderate-to-severe plaque psoriasis, and LUCENTIS(r) (ranibizumab injection), a monoclonal antibody product marketed worldwide (by Genentech and Novartis AG) to treat neovascular (wet) age-related macular degeneration.
The company has built a premier antibody discovery and development platform that includes access to seven of the leading commercially available antibody phage display libraries and XOMA's proprietary Human Engineering(tm) and bacterial cell expression (BCE) technologies. More than 45 companies have signed BCE licenses. XOMA's development collaborators include Lexicon Pharmaceuticals, Inc., Novartis, Schering-Plough Research Institute and Takeda Pharmaceutical Company Limited. With a fully integrated product development infrastructure, XOMA's product development capabilities extend from preclinical sciences to product launch. For more information, please visit the company's website at www.xoma.com.
Certain statements contained herein concerning the development of XOMA 052 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. These risks, including those related to 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); uncertainties regarding the status of biotechnology patents; uncertainties as to the cost of protecting intellectual property; changes in the status of the existing collaborative and licensing relationships; the ability of collaborators, licensees and other third parties to meet their obligations; market demand for products; scale up and marketing capabilities; competition; international operations; share price volatility; XOMA's financing needs and opportunities and risks associated with XOMA's status as a Bermuda company, are described in more detail in XOMA's most recent annual report on Form 10-K and in other SEC filings. Consider such risks carefully in considering XOMA's prospects.
CONTACT: XOMA Ltd. Investor Relations and Corporate Communications Greg Mann 510-204-7270 email@example.com
Released July 16, 2007