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New data from PDL suggests Nuvion improves symptoms of Crohn's disease, ulcerative colitis
By Lisa Kerner
Erie, Pa., May 24 - PDL BioPharma, Inc. said new data from studies of Nuvion (visilizumab) in Crohn's disease and ulcerative colitis suggest that Nuvion may have had a role in symptom improvement following intravenous bolus injection of the drug.
The data were presented at the annual Digestive Disease Week conference in Los Angeles, according to a company news release.
Nuvion, a humanized monoclonal antibody that binds to the protein CD3, is being studied as a potential treatment for various autoimmune diseases such as inflammatory bowel disease.
Investigators also presented research data that characterize Nuvion's potential mechanism of action and support the continued investigation of Nuvion in patients with intravenous steroid-refractory ulcerative colitis.
"We are encouraged by the growing body of clinical evidence suggesting Nuvion is a clinically active treatment for patients with CD [Crohn's disease] as well as UC [ulcerative colitis]", chief medical officer Steven Benner said in the release.
"Based on the early results presented here, we are engaged in active discussions with our advisors to determine next steps to further evaluate Nuvion's potential in CD."
PDL is continuing to enroll patients in its pivotal phase 2/3 Restore 1 trial of Nuvion as a potential treatment option in intravenous steroid-refractory ulcerative colitis patients. A second pivotal phase 3 study of Nuvion in ulcerative colitis patients is planned for later this year, officials said.
Based in Fremont, Calif., PDL markets and sells a portfolio of products in the acute-care hospital setting in the United States and Canada.
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