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XOMA's Development Partner SERVIER Launches Proof-of-Concept Clinical Program for Gevokizumab25/06/2013
Program Will Be Initiated With the Launch of a Study in Polymyositis/Dermatomyositis
BERKELEY, Calif., June 25, 2013 (GLOBE NEWSWIRE) -- XOMA Corporation (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, today 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.
"SERVIER believes gevokizumab has the potential to treat a wide range of indications beyond Behçet's uveitis, non-infectious uveitis, and cardiovascular diseases," stated John Varian, Chief Executive Officer of XOMA. "We are impressed with the breadth and depth of SERVIER's development plan. The first indication they are studying is polymyositis/dermatomyositis. Once SERVIER's POC program is fully underway, we anticipate gevokizumab will be undergoing safety and efficacy evaluations in over a dozen potential indications between SERVIER's and our efforts."
"This POC in polymyositis/dermatomyositis is paving the way for gevokizumab in a new area of pathologies with clear unmet medical needs. The strong existing scientific rationale for the role of IL-1 beta modulation in this disease is making us particularly committed for moving forward this study," indicated Dr. E. Canet, MD, PhD, President R&D of SERVIER.
For Dr. Jean-Philippe Seta, Chief Executive Officer of SERVIER, "Our core mission is to offer patients suffering from debilitating inflammatory diseases new therapeutic solutions. Gevokizumab has the potential to be one such solution."
XOMA provided no further details on SERVIER's POC program nor the timing of when the studies will launch. Details of the multiple clinical trials from both companies can be found on www.clinicaltrials.gov and www.clinicaltrialsregister.eu.
Gevokizumab is a potent monoclonal antibody with unique allosteric modulating properties and 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 uveitis (including Behçet's uveitis), cardiovascular disease, and other auto-inflammatory diseases.
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. XOMA anticipates selecting its next Phase 3 indication by the end of 2013. The Company reported data from a successful Phase 2 study in moderate to severe inflammatory acne in January 2013. XOMA anticipates results from its POC study in erosive osteoarthritis of the hand and data from the National Eye Institute's study of gevokizumab in patients with active non-infectious anterior Scleritis later this year. XOMA recently launched a pilot study in pyoderma gangrenosum, a rare skin ulceration disease. 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. Information about gevokizumab clinical studies can be found at www.clinicaltrials.gov and www.clinicaltrialsregister.eu.
XOMA has built a portfolio of innovative therapeutic antibodies, both in late-stage clinical development and in preclinical research. 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's lead product candidate, gevokizumab (IL-1 beta modulating antibody), is in a global Phase 3 program in non-infectious uveitis with its partner SERVIER and multiple proof-of-concept studies in other IL-1-mediated diseases. 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.
SERVIER is a privately run French research-based pharmaceutical company. Current therapeutic domains for SERVIER medicines are cardiovascular, metabolic, neurological, psychiatric and bone and joint diseases, as well as oncology. SERVIER is established in 140 countries worldwide with over 20,000 employees and a 2012 turnover of €3.9 billion. SERVIER invests 25% of its turnover in R&D.
More information is available at: www.servier.com.
Certain statements contained in this press release including, but not limited to, statements related to XOMA's Phase 2 POC program, SERVIER's POC program, the data generated by studies in those programs and the indications of future Phase 3 studies on gevokizumab, 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. 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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