- News Library
- Servier Medical Art
- Partnering & Licensing
XOMA announces Servier has initiated a proof-of-concept Gevokizumab study in patients with a history of acute coronary syndrome29/11/2012
BERKELEY, Calif., Nov. 29, 2012 (GLOBE NEWSWIRE) -- XOMA Corporation (Nasdaq:XOMA) today 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 recognized for its global cardiovascular franchise and is well positioned for developing gevokizumab in cardiovascular disease," stated John Varian, Chief Executive Officer of XOMA. "While Servier has world-wide rights and pays all gevokizumab development costs for cardiovascular indications, XOMA has the option to acquire the U.S. and Japanese rights in this therapeutic area. As Servier develops gevokizumab in cardiovascular indications, it could become significantly more valuable to XOMA."
"Servier is very committed to developing innovative treatments for cardiovascular diseases with clear unmet medical needs, such as the Acute Coronary Syndrome. The potential anti-inflammatory properties of gevokizumab may ultimately prove its clinical value in this disease. Servier is delighted by this new and important step in the clinical development of the drug," said Isabelle Tupinon-Mathieu, M.D., Head of Therapeutic Research and Development at Servier.
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.
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. Information on all gevokizumab clinical studies can be found at www.clinicaltrials.gov and www.clinicaltrialsregister.eu
Gevokizumab has been granted Orphan Drug Designation by the U.S. Food & Drug Administration (FDA) for the treatment of non-infectious intermediate, posterior, or pan-uveitis, or chronic non-infectious anterior uveitis.
About XOMA Corporation
XOMA combines a portfolio of innovative therapeutic antibodies, both in late-stage clinical development and in preclinical research, with its recently launched commercial operations. XOMA focuses its antibody research and development on allosteric modulation, which offers opportunities for new classes of therapeutic antibodies to treat a wide range of human diseases. XOMA is developing its lead product gevokizumab (IL-1 beta modulating antibody) with Servier through a global Phase 3 program in non-infectious uveitis and ongoing proof-of-concept studies in other IL-1-mediated diseases. XOMA reaffirmed it expects to have top-line data from its ongoing proof-of-concept study of gevokizumab to treat moderate to severe acne vulgaris at year end 2012. XOMA's scientific research also produced the XMet program, which consists of three classes of preclinical antibodies, including Selective Insulin Receptor Modulators (SIRMs) that could have a major effect on the treatment of diabetes.
More detailed information can be found at www.xoma.com
Certain statements contained herein concerning the enrollment, timing, completion and the successful outcome of the gevokizumab clinical trials and regulatory approval of its product candidates, 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. 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 and other risks, including those scale-up, manufacturing and marketing capabilities, are described in more detail in XOMA's most recent filing on Form 10-K and in other SEC filings. Consider such risks carefully when considering XOMA's prospects as these statements are based on assumptions that may not prove accurate.