XOMA Selects Non-Infectious Anterior Scleritis as Next Indication in Gevokizumab Proof-of-Concept Program
BERKELEY, Calif., Dec 31, 2012 (GLOBE NEWSWIRE via COMTEX) --
XOMA Corporation (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, today announced it has selected active non-infectious anterior scleritis, which is the inflammation of the sclera (the fibrous white membrane surrounding the eyeball excluding the cornea), as the third indication in XOMA's gevokizumab proof-of-concept program. The Company is working with the National Eye Institute ("NEI"), one of the U.S. National Institutes of Health, on designing the protocol for this study.
"Both non-infectious scleritis and non-infectious uveitis have been associated with interleukin-1 beta. As we narrowed our potential therapeutic targets for inclusion in our POC program, we felt there was a strong rationale to conduct one of the studies in a second ocular indication, particularly one that is treated by the same physician specialist as the NIU patient population," stated Paul Rubin, Senior Vice President of Research and Development and Chief Medical Officer of XOMA.
About Gevokizumab and Interleukin-1 Inhibition
Gevokizumab (XOMA 052) is a potent monoclonal antibody with 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 that has been shown to be involved in non-infectious uveitis, including Behçet's uveitis, cardiovascular disease, and other auto-inflammatory diseases. By binding to IL-1 beta, gevokizumab inhibits the activation of the IL-1 receptor, thereby modulating the cellular signaling events that produce inflammation.
Gevokizumab has been studied in nearly 500 patients, with approximately 300 patients on treatment for six months, and has been shown to be well-tolerated. As previously reported, in a proof-of-concept Phase 2 trial of gevokizumab in Behçet's uveitis, all seven patients displayed rapid reduction of intraocular inflammation and improvement in visual acuity or other ophthalmic measures after a single treatment and following discontinuation of immunosuppressive drugs such as cyclosporine and/or azathioprine. Five of the patients were retreated with gevokizumab due to a recurring uveitis exacerbation and all responded again to treatment.
Scleritis involves inflammation and swelling of the scleral and episcleral tissues, the fibrous white membrane that surrounds the eyeball excluding the cornea. Scleritis is classified as anterior or posterior and is subdivided further into diffuse, nodular and necrotizing scleritis with or without inflammation (scleromalacia perforans). Anterior scleritis is the most common form (80-85%) with the diffuse and nodular variants occurring almost equally, and it disproportionately impacts women between the ages of 40 and 60 who may have an underlying systemic inflammatory condition. Scleritis is associated with severe pain and it can lead to ocular complications including keratitis, uveitis, and glaucoma, and if left untreated it may cause vision loss.
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 Les Laboratoires Servier (Servier) through a global Phase 3 program in non-infectious uveitis and ongoing 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.
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Certain statements contained in this press release including, but not limited to, statements related to anticipated timing of initiation and successful completion XOMA's proof-of-concept program and clinical trials and the potential impact of allosteric modulation on the treatment of human diseases, 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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