PDL BioPharma, Inc (FREMONT, California), a clinical-stage biopharmaceutical company focusing on discovering, developing, and commercializing humanized monoclonal antibodies for autoimmune diseases and cancer, announced it will advance Nuvion® (visilizumab), a humanized antibody, into a phase III clinical program in patients with intravenous steroid-refractory ulcerative colitis (IVSR-UC). Advancement was recommended by an independent external data monitoring committee based on a planned safety and ‘futility' assessment of data from 60 patients with IVSR-UC who are enrolled in an ongoing phase II/III clinical trial of the Nuvion antibody. As a result, the company will continue with enrollment in this ongoing trial, known as RESTORE 1, and begin a second pivotal trial in the same patient population, known as RESTORE 2.

Patients with IVSR-UC have exhausted other treatment options and are facing surgery to remove their colons. A range of 25% to 40% of UC patients eventually fail to respond to standard medical therapy of oral and intravenous steroids, and an estimated 60,000 UC patients annually in both the US and Europe undergo colectomies.

Nuvion binds to CD3 on T-cells. The CD3 antigen is a protein complex comprising four distinct chains associated with the T-cell receptor (TCR) and the zeta-chains. The TCR complex is made up of both TCR and zeta-chains. Partial receptor agonists of CD3 have been shown to induce regulatory cytokines, to promote survival and expansion of regulatory T-cells, to induce apoptosis and anergy of pathogenic T-cells, and to utilize preferential targeting of immunological tolerance without general immune suppression.

Nuvion is also currently being tested in phase II studies in patients with Crohn's disease. PDL holds all worldwide rights to the development, manufacturing, and sales of Nuvion.

—G. Stephens