XOMA will be presenting new preclinical data in an animal model of Type 2 diabetes in which its anti-inflammatory therapeutic antibody candidate, XOMA 052, was used as monotherapy and in combination with the marketed anti-diabetic drugs exendin-4 (Byetta®) or sitagliptin (Januvia)
ORLANDO, FL, USA | June 26, 2010 | XOMA Ltd. (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, will be presenting new preclinical data in an animal model of Type 2 diabetes in which its anti-inflammatory therapeutic antibody candidate, XOMA 052, was used as monotherapy and in combination with the marketed anti-diabetic drugs exendin-4 (Byetta®) or sitagliptin (Januvia®). The new results, to be presented at the American Diabetes Association 70th Scientific Sessions add to the growing body of research supporting the development of XOMA 052, an inhibitor of the pro-inflammatory cytokine interleukin-1 beta (IL-1 beta), in Type 2 diabetes.
Two posters will be presented on Monday, June 28 from 12:00 PM to 2:00 PM in the Orange County Convention Center, Hall C. Abstract 1811-P is entitled "Combination Studies of the Anti-Interleukin-1 beta Monoclonal Antibody XOMA 052 with Exendin-4 or Sitagliptin in a Diet-Induced Obesity Mouse Model of Type 2 Diabetes Mellitus." XOMA 052 was evaluated in combination with either exendin-4 or sitagliptin. As previously reported, researchers demonstrated that, in a mouse model, XOMA 052 had significant beneficial effects on fasting insulin, stimulated insulin secretion, beta-cell proliferation and beta-cell mass. The results also demonstrated no deleterious effects with the two-drug combinations and improved insulin tolerance with a combination of XOMA 052 and sitagliptin. The results support the evaluation of XOMA 052 in combination with either sitagliptin or exendin-4 in Type 2 diabetes patients.
Abstract 1820-P is entitled "Inhibition of Interleukin-1 beta with the Monoclonal Antibody XOMA 052 Reveals the Differential Sensitivities of Glycemic and Pancreatic Function Parameters to Chronic Inflammation." The poster details an extended pharmacological study of XOMA 052 in the diet-induced obesity mouse model. This study examined different doses of XOMA 052 and suggests that pancreatic function parameters in the diet-induced obesity model may be differentially sensitive to locally available IL-1 beta.
The final abstract 2467-PO, accepted as published-only, is entitled "The Role of Interleukin-1 beta in Insulin Resistance." Examined in the abstract were in vitro models that support the hypothesis that IL-1 beta interferes with normal insulin signaling and that XOMA 052 may prevent this interference.
Previously, XOMA has reported results showing that mice treated with XOMA 052 both prophylactically and therapeutically experienced improvement in measures associated with diabetes and cardiovascular disease including reduction in glycosylated hemoglobin (HbA1c) levels, improvement in glucose control, improved beta-cell survival and function, and a reduction in total cholesterol without reduction in high density lipoprotein. Each of these parameters is an important goal for the management of Type 2 diabetes, and well-controlled blood glucose levels and reductions in lipid levels can help minimize the risk of long-term consequences associated with 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 diseases including Type 2 diabetes, cardiovascular disease, rheumatoid arthritis, gout and auto-inflammatory diseases such as Behcet’s uveitis. 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. Positive results from an open-label pilot clinical study evaluating XOMA 052 in patients with exacerbations of uveitis of Behcet’s disease, an auto-inflammatory disease, were recently reported. The Phase 2 diabetes 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 cardivascular 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® (ranibizumab injection) for wet age-related macular degeneration and CIMZIA® (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™, 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 60 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 215 employees at its Berkeley, California location. For more information, please visit http://www.xoma.com.
The XOMA Ltd. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=5960
SOURCE: : XOMA
Post Views: 42
XOMA will be presenting new preclinical data in an animal model of Type 2 diabetes in which its anti-inflammatory therapeutic antibody candidate, XOMA 052, was used as monotherapy and in combination with the marketed anti-diabetic drugs exendin-4 (Byetta®) or sitagliptin (Januvia)
ORLANDO, FL, USA | June 26, 2010 | XOMA Ltd. (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, will be presenting new preclinical data in an animal model of Type 2 diabetes in which its anti-inflammatory therapeutic antibody candidate, XOMA 052, was used as monotherapy and in combination with the marketed anti-diabetic drugs exendin-4 (Byetta®) or sitagliptin (Januvia®). The new results, to be presented at the American Diabetes Association 70th Scientific Sessions add to the growing body of research supporting the development of XOMA 052, an inhibitor of the pro-inflammatory cytokine interleukin-1 beta (IL-1 beta), in Type 2 diabetes.
Two posters will be presented on Monday, June 28 from 12:00 PM to 2:00 PM in the Orange County Convention Center, Hall C. Abstract 1811-P is entitled "Combination Studies of the Anti-Interleukin-1 beta Monoclonal Antibody XOMA 052 with Exendin-4 or Sitagliptin in a Diet-Induced Obesity Mouse Model of Type 2 Diabetes Mellitus." XOMA 052 was evaluated in combination with either exendin-4 or sitagliptin. As previously reported, researchers demonstrated that, in a mouse model, XOMA 052 had significant beneficial effects on fasting insulin, stimulated insulin secretion, beta-cell proliferation and beta-cell mass. The results also demonstrated no deleterious effects with the two-drug combinations and improved insulin tolerance with a combination of XOMA 052 and sitagliptin. The results support the evaluation of XOMA 052 in combination with either sitagliptin or exendin-4 in Type 2 diabetes patients.
Abstract 1820-P is entitled "Inhibition of Interleukin-1 beta with the Monoclonal Antibody XOMA 052 Reveals the Differential Sensitivities of Glycemic and Pancreatic Function Parameters to Chronic Inflammation." The poster details an extended pharmacological study of XOMA 052 in the diet-induced obesity mouse model. This study examined different doses of XOMA 052 and suggests that pancreatic function parameters in the diet-induced obesity model may be differentially sensitive to locally available IL-1 beta.
The final abstract 2467-PO, accepted as published-only, is entitled "The Role of Interleukin-1 beta in Insulin Resistance." Examined in the abstract were in vitro models that support the hypothesis that IL-1 beta interferes with normal insulin signaling and that XOMA 052 may prevent this interference.
Previously, XOMA has reported results showing that mice treated with XOMA 052 both prophylactically and therapeutically experienced improvement in measures associated with diabetes and cardiovascular disease including reduction in glycosylated hemoglobin (HbA1c) levels, improvement in glucose control, improved beta-cell survival and function, and a reduction in total cholesterol without reduction in high density lipoprotein. Each of these parameters is an important goal for the management of Type 2 diabetes, and well-controlled blood glucose levels and reductions in lipid levels can help minimize the risk of long-term consequences associated with 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 diseases including Type 2 diabetes, cardiovascular disease, rheumatoid arthritis, gout and auto-inflammatory diseases such as Behcet’s uveitis. 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. Positive results from an open-label pilot clinical study evaluating XOMA 052 in patients with exacerbations of uveitis of Behcet’s disease, an auto-inflammatory disease, were recently reported. The Phase 2 diabetes 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 cardivascular 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® (ranibizumab injection) for wet age-related macular degeneration and CIMZIA® (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™, 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 60 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 215 employees at its Berkeley, California location. For more information, please visit http://www.xoma.com.
The XOMA Ltd. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=5960
SOURCE: : XOMA
Post Views: 42
