PDL BioPharma Announces Long-Term Nuvion Data
Nuvion, an antibody in development as a treatment for intravenous steroid-refractory ulcerative colitis, administered on day 1 and day 2, produced a sustained clinical response up to 310 days and was adequately tolerated.
The results presented were from long-term follow up of 138 patients who had received Nuvion in a Phase 1 and Phase 1/2 study as a treatment for IVSR-UC, which contributes to the majority of an estimated 30,000 colectomy procedures performed in the U.S. each year. In addition, early data also will be presented at the meeting regarding the Nuvion antibody's potential as a treatment for Crohn's disease.
"The data presented by Professor Sandborn further support our decision to advance Nuvion into a Phase 3 program in patients with IV steroid-refractory ulcerative colitis," said Mark McCamish, M.D., Ph.D., PDL's senior vice president and chief medical officer. "Patients with severe ulcerative colitis face surgical intervention or colectomy, and positive results from our Phase 3 program would lead to a welcomed treatment for these difficult-to-treat patients who currently have very limited non-surgical options."
Nuvion is a humanized monoclonal antibody designed to target and modulate the action of T cells, the cells believed to cause inflammation leading to ulcerative colitis, with the aim of significantly reducing the symptoms of the disease and potentially delaying or avoiding the need for colectomy, or surgical removal of the colon. An estimated 60,000 colectomy procedures are performed in the U.S. and Europe every year. In April, after review of the current data from an external data monitoring committee, PDL announced that it would advance the Nuvion antibody into a second pivotal study in patients with IVSR-UC, the most severe form of this inflammatory bowel disease that attacks the colon.
In the study presented by Dr. Sandborn, 138 subjects with IVSR-UC were treated with visilizumab at 5, 7.5, 10, 12.5 or 15 mg/kg intravenously on two consecutive days (Days 1 and 2). Eighty-nine (64.5%) of the 138 patients demonstrated a clinical response at day 30. Clinical response was defined by using one of two standard measures to determine the severity of the patient's ulcerative colitis.
Patients were followed for a median of 356 days, ranging from 21 to 792. During the follow-up period, 53% (73/138) received medical or surgical rescue therapy. Only 28 (35%) of the Day 30 responders ended up undergoing rescue therapy during subsequent observation. Encouraging new data presented at DDW from this study show the median time to first rescue therapy was 310 days. Forty-six (33%) patients underwent colectomy (colon removal), either as first rescue therapy or subsequent to failed medical rescue.
The Nuvion antibody was adequately tolerated, with 120 (87%) patients experiencing transient, mild to moderate infusion reactions due to cytokine release within the first three days of treatment. These symptoms were minimized with pre-medication and hydration. A total of 17 (12%) patients also experienced serious or opportunistic infections, including localized mucocutaneous herpes and candida infections, but there were no disseminated opportunistic infections. The Nuvion antibody also produced a transient decline in T cells, which generally lasted less than 30 days.