Date: 2012-11-29
Type of information: Initiation of the trial
phase:
Announcement: initiation of the trial
Company: Servier (France) Xoma (USA - CA)
Product: gevokizumab (XOMA 052/S 78989)
Action
mechanism: monoclonal antibody. Gevokizumab (XOMA 052/S 78989) is a potent monoclonal antibody with unique allosteric modulating properties and the potential to treat patients with a wide variety of inflammatory diseases and other diseases. Gevokizumab binds strongly to interleukin-1 beta (IL-1 beta), a pro-inflammatory cytokine that has been shown to be involved in Behçet\'s and other forms of non-infectious uveitis, cardiovascular disease, and other auto-inflammatory diseases. In binding to IL-1 beta, gevokizumab inhibits the activation of the IL-1 receptor, thereby modulating the cellular signaling events that produce inflammation.
Gevokizumab currently is in Phase 3 clinical development in patients with non-infectious uveitis (NIU) involving the intermediate and/or posterior segment of the eye. The global development plan includes a Phase 3 trial to be conducted by Servier in patients with Behçet's uveitis.
Disease: reduction of arterial wall inflammation in patients with marked atherosclerotic plaque inflammation
Therapeutic area: Cardiovascular diseases
Country:
Trial details:
Latest
news: XOMA Corporation has announced its partner, Servier, has initiated the first Servier -sponsored proof-of-concept study in a cardiovascular indication. The study has opened for patient enrollment. The study is expected to enroll 45 patients who have experienced Acute Coronary Syndrome (ACS) in the past three to twelve months. The objective of this study is to evaluate the effect of subcutaneous administration of 30 mg gevokizumab as compared to placebo in reducing arterial wall inflammation in patients with marked atherosclerotic plaque inflammation. The primary endpoint Servier will be assessing is the change in the mean target to background ratio (TBR) of the radioactive tracer FDG assessed by PET/CT after three months of treatment. The study also will determine gevokizumab's effect on a number of cardiac and vascular biological blood biomarkers.
Servier is XOMA's development and commercialization partner for gevokizumab. XOMA holds rights to gevokizumab in the U.S. and Japan for non-cardiometabolic indications, including non-infectious uveitis, acne, and erosive osteoarthritis of the hand for which clinical studies are ongoing.
