"During the first quarter of this year, we made significant progress toward achieving our goal of becoming a commercial organization," said John Varian, Chief Executive Officer of XOMA. "Servier is just one ocular exacerbation away from being able to close the EYEGUARD(TM)-B study database and expects to reach the targeted ocular exacerbation event any day. If the study results are positive, we will perform an analysis of the full EYEGUARD-B dataset and plan to quickly request a pre-Biologics License Application meeting with the U.S. Food and Drug Administration."
He added, "We presented detailed results of our Phase 1 study of XOMA 358 at the recent ENDO Conference, which generated significant interest from the clinical community. We are in the process of assessing optimal indications to pursue in the Phase 2 development of this first-in-class compound that down-regulates the insulin receptor and its downstream signaling. We hope to expedite the clinical development of XOMA 358, as new treatment options are urgently needed for patients who are affected by the overproduction of insulin or atypical responses to insulin."
BERKELEY, Calif., May 4, 2015 (GLOBE NEWSWIRE) -- XOMA Corporation (XOMA), a leader in the discovery and development of therapeutic antibodies, announced today that Paul Rubin, the Company's Senior Vice President, Research and Development, and Chief Medical Officer, is scheduled to present at the Credit Suisse Antibody Day on May 6, 2015 at 8:35 a.m. Eastern time.
"8:02 am XOMA announces initiation of Phase 2 study of Gevokizumab to treat patients with Diabetic Nephropathy (XOMA) : Co announced gevokizumab will be tested in a Phase 2 study in patients with Type 2 diabetes and diabetic kidney disease, clinically referred to as diabetic nephropathy. The international, multicenter, randomized, double-blind, parallel-group, placebo-controlled study is expected to enroll 370 patients who will be randomized to receive gevokizumab or placebo for 52 weeks. The primary objective of this study is to detect the existence of an overall dose-response relationship of subcutaneously dosed gevokizumab on the measured glomerular filtration rate (mGFR), an accurate measure of kidney function, at Week 52. "