XOMA Completes Enrollment in Phase 2 Proof-of-Concept Gevokizumab Trial in Patients With Erosive Osteoarthritis of the Hand
BERKELEY, Calif., July 22, 2013 (GLOBE NEWSWIRE) -- XOMA Corporation (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, today confirmed it has completed patient enrollment in the Company's Phase 2 proof-of-concept (POC) study designed to evaluate the potential for gevokizumab to improve pain symptoms, physical function and structural abnormalities in patients with active inflammatory, erosive osteoarthritis of the hand (EOA) and elevated C-reactive protein (CRP) levels. XOMA's study enrolled approximately 90 patients who were randomized 2:1 to receive 60mg of gevokizumab dosed subcutaneously once monthly or placebo. The study was designed and powered to detect a significant improvement from baseline versus placebo in the mean Australian/Canadian Hand Osteoarthritis Index (AUSCAN™) pain score in the target hand at Day 84. The study also is capturing multiple outcome measures, including pain, stiffness, physical function, X-ray, radiographic and MRI changes, as well as changes in CRP and concomitant acetaminophen use, at three and six months. The Company anticipates having preliminary top-line data for the AUSCAN score in October.
XOMA also provided an update on the EOA study in patients with non-elevated CRP. This study was opened for enrollment in May, and investigators have enrolled approximately 40 patients of the targeted 90 who had qualified for the original EOA study with the exception that they did not have elevated CRP levels. This supplemental study will help inform the design of the potential Phase 3 studies of gevokizumab in EOA.
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-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 full results from its two POC studies in patients with 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. Additionally, the Company 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, as well as a POC study in polymyositis/dermatomyositis. Information about gevokizumab clinical studies can be found at www.clinicaltrials.gov and www.clinicaltrialsregister.eu.
About Erosive Osteoarthritis of the Hand
Erosive osteoarthritis of the hand (EOA) is caused by the breakdown of the body's natural balance between cartilage formation and degradation, which leads to the narrowing of the space between the first and second joints in the fingers. Patients with EOA experience high degrees of pain, including throbbing, swelling, and prolonged periods of morning stiffness. Over time, the joints become deformed, impacting hand function and ultimately reducing EOA patients' quality of life. Approximately four million people in the U.S. have been diagnosed with EOA, and the disease affects women twelve times more often than men for reasons that are not understood by the scientific or medical community.
Published studies have highlighted interleukin 1-beta (IL-1β) for its key involvement in the development of EOA and the destruction of the cartilage matrix resulting from the disease. XOMA believes gevokizumab may be able to reduce the symptoms associated with EOA by modulating IL-1β levels. EOA is the second indication in XOMA's gevokizumab Phase 2 proof-of-concept program.
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 anticipated timing of initiation and completion of clinical trials and proof-of-concept trials, anticipated size of clinical trials, continued sales of approved products, sufficiency of our cash resources and anticipated levels of cash utilization, 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.
CONTACT: XOMA Corporation Company and Investor Contact: Ashleigh Barreto 510-204-7482 firstname.lastname@example.org Juliane Snowden The Oratorium Group, LLC email@example.com Media Contact: Canale Communications Carolyn Hawley 619-849-5375 firstname.lastname@example.org
Released July 22, 2013