XOMA Announces Clinical Study Investigating Gevokizumab in Patients With Non-Infectious Anterior Scleritis Has Opened for Enrollment at the National Eye Institute
BERKELEY, Calif., April 10, 2013 (GLOBE NEWSWIRE) -- XOMA Corporation (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, today announced the National Eye Institute ("NEI"), one of the U.S. National Institutes of Health, has opened its non-infectious, active, anterior scleritis trial for patient enrollment. The open-label single-arm Phase 1/2 study is designed to assess the safety and potential efficacy of gevokizumab in patients experiencing non-infectious, active, anterior scleritis, which is the inflammation of the sclera (the fibrous white membrane surrounding the eyeball excluding the cornea). This is XOMA's third indication in a program of three proof-of-concept ("POC") studies for gevokizumab.
"The NEI is recognized globally for its dedication to improving ocular health, and it has access to patients most in need of potential new therapeutic options," stated Paul Rubin, Senior Vice President of Research and Development and Chief Medical Officer of XOMA. "We are delighted the NEI team has chosen to study the effect of gevokizumab in these patients."
The NEI is expected to enroll 10 non-infectious active anterior scleritis patients with scleral inflammatory grade of ≥ 1-plus in at least one eye using a standardized photographic scleritis grading system developed at NEI. All patients will receive 60 mg of gevokizumab dosed every four weeks for a 16-week period. Patients who respond will have the option to continue treatment for an additional 20 weeks. Responders in the study are defined as patients who experience a 2-step reduction on a five point scale from 0 to 4 or reach Grade 0 in scleral inflammation in the study eye. Secondary measurements will include changes in visual acuity, changes in intraocular pressure and changes in scleral grading. Safety will be monitored throughout the trial.
About Gevokizumab and Interleukin-1 Inhibition
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 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 over 500 patients, with approximately 300 patients on treatment for six months, and has been shown to be well-tolerated. Information about gevokizumab clinical studies can be found at www.clinicaltrials.gov.
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 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.
Certain statements contained in this press release including, but not limited to, statements related to anticipated timing of initiation and successful completion of clinical trials and anticipated size of clinical trials, 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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Released April 10, 2013