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Servier Initiates Phase 2 Study of Gevokizumab in Patients with Diabetic Nephropathy01/04/2015
Berkeley, CA – April 1, 2015 – XOMA Corporation (Nasdaq: XOMA), a leader in the discovery and development of therapeutic antibodies, announced today that its development partner, SERVIER, will test gevokizumab in a Phase 2 study in patients with Type 2 diabetes and diabetic kidney disease, clinically referred to as diabetic nephropathy. The international, multicenter, randomized, double-blind, parallel-group, placebo-controlled study is expected to enroll 370 patients who will be randomized to receive gevokizumab or placebo for 52 weeks. The primary objective of this study is to detect the existence of an overall dose-response relationship of subcutaneously dosed gevokizumab on the measured glomerular filtration rate (mGFR), an accurate measure of kidney function, at Week 52. The study also will determine gevokizumab’s effect on a number of biological biomarkers assessing kidney function. Servier will fully sponsor the study’s execution and cost.
“We are very pleased Servier has elected to pursue gevokizumab in patients with diabetic nephropathy,” stated John Varian, Chief Executive Officer of XOMA. “This disease, which is a common long-term complication associated with diabetes, has long been identified as a disease that needs new therapeutic options. Twenty to thirty percent of all diabetics will show signs of diabetic nephropathy, and many will progress to end-stage renal disease. Treating patients early hopefully will reduce the number who progress to the most serious stages of the disease.”
“Servier is highly committed to developing innovative treatments for diseases with clear unmet medical needs, such as the diabetic nephropathy. The potential anti-inflammatory properties of gevokizumab ultimately may 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., R&D Vice President, Head of Metabolism and Cardiovascular Innovation Centers at Servier.
Inflammatory kidney disease is a cause of morbidity and mortality in diabetic patients. There is an increasing amount of evidence that 1L-1 beta is one of the cytokines involved in the pathogenesis of diabetic nephropathy. A mouse model study of renal inflammation showed gevokizumab significantly decreased proteinuria, a commonly seen abnormality in diabetic nephropathy, and several other renal function biomarkers compared to placebo. Gevokizumab also reduced inflammatory cytokine responses in blood and kidney cortex extracts, as well as reduced development of fibrosis, the scarring of tissues that is central to the reduction of kidney function.
Gevokizumab is a potent monoclonal antibody with unique allosteric modulating properties and has the potential to treat patients with a wide variety of inflammatory and other diseases. Gevokizumab binds strongly to interleukin-1 beta (IL-1 beta), a pro-inflammatory cytokine, and modulates the cellular signaling events that produce inflammation. IL-1 beta has been shown to be involved in diverse array of disease states, including non-infectious and Behçet's disease uveitis, cardiometabolic diseases and other auto-inflammatory diseases.
Gevokizumab currently is being studied in multiple indications, including global Phase 3 clinical programs in Behçet’s disease uveitis, non-infectious uveitis and pyoderma gangrenosum. Information about all gevokizumab clinical studies can be found at www.clinicaltrials.gov and www.clinicaltrialsregister.eu.
About XOMA Corporation
XOMA’s innovative product candidates are the result of the Company’s expertise in developing ground-breaking monoclonal antibodies, including allosteric modulating antibodies, which have created new opportunities to potentially 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 for Behçet’s disease uveitis and non-infectious uveitis. XOMA also has an ongoing Phase 3 study of gevokizumab in pyoderma gangrenosum. Additionally, XOMA's scientific research has produced the XMet program, which consists of three classes Selective Insulin Receptor Modulators (SIRMs) antibodies. XOMA 358, the lead antibody in the XMetD program that recently completed Phase 1 testing, is an allosteric modulating monoclonal antibody that reduces both the binding of insulin to its receptor and down-regulates insulin signaling and could have a major effect on the treatment of abnormal metabolic states.
More detailed information can be found at www.xoma.com.
Servier is an independent French research-based pharmaceutical company. Its development is driven by the pursuit of innovation in the therapeutic areas of cardiovascular, metabolic, central nervous system, psychiatric, bone, muscle and joint diseases, as well as cancer.
In 2014, the company recorded a turnover of 4 billion euros.
92% of Servier medicines are prescribed outside of France.
28% of turnover from Servier drugs was reinvested in Research and Development in 2014.
With a strong international presence in 146 countries, Servier employs more than 21 400 people worldwide.
More information is available at: www.servier.com
Servier Communication Department
Tel: +33 1 5572 6037
Certain statements contained in this press release including, but not limited to, statements related to anticipated timing of initiation and completion of clinical trials, anticipated size and rate of enrollment of clinical trials, regulatory approval of unapproved product candidates, the anticipated success of any product launch, or statements 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. These statements are based on assumptions that may not prove accurate, and 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. Potential risks to XOMA meeting these expectations 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. Any forward-looking statement in this press release represents XOMA's views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. XOMA disclaims any obligation to update any forward-looking statement, except as required by applicable law.
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