Date: 2013-06-25
Type of information: Initiation of the trial
phase: POC study
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.Gevokizumab currently is being studied in a global Phase 3 clinical program, termed EYEGUARD™, which is being conducted by Servier and Xoma. This program is designed to determine gevokizumab\'s ability to treat acute non-anterior non-infectious uveitis (NIU) in EYEGUARD-A, to prevent disease flares in patients with Behçet\'s uveitis in EYEGUARD-B, and to prevent disease flares in NIU patients who are controlled with steroids and immunosuppressants in EYEGUARD-C.
Xoma has a Proof-of-Concept (POC) program underway in which the Company is exploring the efficacy and safety of gevokizumab in multiple indications. The company anticipates selecting its next Phase 3 indication by the end of 2013. Separately, Servier initiated a Phase 2 study to determine gevokizumab\'s ability to reduce arterial wall inflammation in patients with marked atherosclerotic plaque inflammation and who have experienced an acute coronary syndrome in the previous twelve months.
Disease: polymyositis/dermatomyositis
Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases
Country:
Trial details:
Latest
news: * On June 25, 2013, Xoma has announced that its development partner, Servier, has launched its own independent Proof-of-Concept (POC) clinical program to evaluate the safety and efficacy of gevokizumab, a potent modulator of interleukin-1 beta (IL-1 beta). Xoma launched a similar POC clinical program in November 2011 , which included studies in three separate indications: moderate to severe inflammatory acne vulgaris, erosive inflammatory osteoarthritis of the hand, and non-anterior scleritis. Servier has selected several indications across multiple therapeutic areas. The first indication Servier s studying is polymyositis/dermatomyositis. Xoma provided no further details on Servier\'s POC program nor the timing of when the studies will launch.
