BERKELEY, Calif., April 28, 2014 (GLOBE NEWSWIRE) -- XOMA Corporation (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, announced today that based on its meeting with the U.S Food and Drug Administration (FDA), the Company is finalizing its plans for a gevokizumab Phase 3 program in pyoderma gangrenosum (PG), a rare neutrophilic dermatosis of painful expanding necrotic skin ulcers. During the meeting, the Company and the FDA reviewed the data generated from XOMA's pilot trial in six PG patients. The pilot study was designed to determine if gevokizumab, an IL-1 beta modulating antibody, should be explored in pivotal studies in patients with active PG. XOMA is incorporating the FDA's verbal and written responses regarding the clinical design of the studies into a final Phase 3 program, which it will submit to the Agency for any final comments.
The Phase 3 program is expected to include two double-blind, placebo-controlled clinical studies, each of which is designed to enroll approximately 60 patients with active PG. The primary endpoint is complete wound closure of the target ulcer at approximately four months. XOMA anticipates conducting these parallel studies in the United States and several other countries.
"The interest we have received from the medical community and the patients who suffer from pyoderma gangrenosum ulcerations reflect their desire to have access to therapeutic options that have been studied specifically in and are approved for this under-served patient population. We were very pleased the FDA agreed PG is a serious rare condition that has been identified as an unmet medical need with no approved therapies and that the input we received has allowed us to design a Phase 3 program we believe we can successfully execute in our targeted PG population," stated Paul Rubin, Senior Vice President, Research and Development and Chi
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Suppose you were like the Bakers who havnt sold a share and wanted more? what would you do?because they dont care what the price is today they care after results.
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you write the same blcht every time you post give it up,soon this stock will double and you will still be there picking your nose