XOMA Launches XOMA 358 Clinical Development

XOMA Corporation XOMA, a leader in the discovery and development of therapeutic antibodies, today announced it has initiated dosing in its Phase 1 study exploring the safety and tolerability of single intravenous doses (IV) of XOMA 358, the lead compound from the Company's XMetD program, in healthy volunteers. The study also will explore the biologic effects of ascending single IV doses of XOMA 358 on glucose and insulin levels as well as insulin sensitivity. XOMA 358 is a fully human, allosteric monoclonal antibody that reduces both the binding of insulin to its receptor and downstream insulin signaling. "XOMA 358 could demonstrate its ability to treat several rare diseases resulting from the body's overproduction of insulin, including congenital hyperinsulinism, a series of genetic disorders causing an inability to control insulin levels, and insulinoma, a tumor of the insulin producing cells in the pancreas," stated Paul Rubin, M.D., Senior Vice President, Research and Development, and Chief Medical Officer of XOMA. "As these diseases have severe consequences, novel therapies clearly are needed. In addition to showing the safety and pharmacokinetics of this unique antibody, the study is designed to show relevant biologic activity and inform dose selection for Phase 2 trials." XOMA 358 was developed at XOMA as part of a broader insulin receptor program called XOMA Metabolic, or XMet. Two other product candidates also were discovered in the XMet program, XMetA and XMetS, both of which XOMA intends to license to a partner with expertise in the development and commercialization of compounds for Types 1 and 2 diabetes. XMetA is designed to activate the insulin receptor and XMetS to sensitize the insulin receptor when in an insulin resistant state. XOMA plans to retain full ownership of XOMA 358, as it aligns with the Company's focus to develop and commercialize products for diseases with significant unmet medical need and treated by the specialist prescriber.
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