BERKELEY, Calif., March 12, 2013 (GLOBE NEWSWIRE) -- XOMA Corporation (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, today announced 2012 operational highlights and financial results for the fourth quarter and year ended December 31, 2012.
2012 Operational Highlights
- Initiated a global Phase 3 gevokizumab clinical trial program, termed EYEGUARD™, in non-infectious intermediate, posterior or pan-uveitis ("NIU"):
- EYEGUARD-A in patients with active NIU, sponsored by XOMA
- EYEGUARD-C in patients with controlled NIU also sponsored by XOMA, and
- EYEGUARD-B in patients with Behçet's uveitis sponsored by XOMA's development and commercialization partner Les Laboratories Servier ("Servier")
- Advanced the Phase 2 proof-of-concept ("POC") program to identify the next Phase 3 indication for gevokizumab. Two of the three studies in the POC program, the moderate-to-severe acne study and the erosive arthritis of the hand study ("EOA"), enrolled patients during 2012. The third indication, non-infectious anterior scleritis, was selected, and XOMA is working with the National Eye Institute ("NEI"), one of the National Institutes of Health, to finalize the study protocol.
- Received Orphan Drug Designation from the U.S. Food and Drug Administration ("FDA") for gevokizumab in the NIU indication.
- Entered into a technology and process transfer agreement with Boehringer Ingelheim and Servier for the commercial manufacture of gevokizumab.
- Announced John Varian had accepted the position of Chief Executive Officer and Paul Rubin, M.D., had been promoted to Senior Vice President, Research and Development, and Chief Medical Officer.
- Raised $79.2 million in two public equity offerings.
- Realized approximately $17.0 million reduction in internal expense reflecting streamlined operations to focus exclusively on value-creating activities.
"2012 was focused on identifying ways to create and capture value from gevokizumab," stated John Varian, Chief Executive Officer of XOMA. "We believe this allosteric modulating antibody has the potential to make a positive impact on the lives of patients across a diverse array of inflammatory diseases. We significantly expanded our Phase 3 program to demonstrate gevokizumab's potential to treat both patients with active NIU and those whose disease is controlled with corticosteroids and immunotherapy. Our Phase 2 POC program was designed to generate the data necessary to guide our selection of the next Phase 3 indication. We made significant progress advancing two of the studies in this program during 2012, and we are working with the NEI on the design for the third study in our overall POC program.