• Amylin Pharmaceuticals Inc., of San Diego, along with partners Eli Lilly and Co., of Indianapolis, and Alkermes Inc., of Cambridge, Mass., initiated a long-term comparator study of a long-acting release (LAR) formulation of Byetta (exenatide) injection in patients with Type II diabetes. The 300-patient, non-inferiority study is designed to assess whether once-weekly exenatide LAR is at least as effective in improving glucose control as twice-daily Byetta, which was approved by the FDA in April.
• CancerVax Corp., of Carlsbad, Calif., said data from its discontinued Phase III trials of Canvaxin in patients with advanced-stage melanoma showed the drug did not demonstrate efficacy as a post-surgical adjuvant treatment. However, the median survival in the Stage III melanoma patients (<5.75 years) and Stage IV melanoma patients (three years) are better than or comparable to the median survival in earlier published results of large studies with similar patient groups. The results were presented at the Society for Surgical Oncology annual meeting in San Diego. CancerVax discontinued the trials last fall. Early this year, the company entered an agreement to merge with privately held Micromet AG, of Munich, Germany, and that deal is expected to close next quarter. (See BioWorld Today, Oct. 5, 2005, and Jan. 10, 2006.)
• Encysive Pharmaceuticals Inc., of Houston, said TBC3711, its selective endothelin receptor antagonist, has been placed on clinical hold due to a finding following dosing with an intravenous version of the drug in a rat that had displayed abnormalities at baseline. Clinical testing with TBC3711, which had entered early clinical testing with oral and intravenous formulations, will be suspended pending further by the company and the FDA.
PDL BioPharma Inc., of Fremont, Calif., said its partner, Lebanon, N.J.-based Orphan Therapeutics LLC, completed enrollment in the pivotal Phase III study of terlipressin for Type I hepatorenal syndrome. The 112-patient study is evaluating the drug on kidney function and survival. Results are anticipated later this year.
YM BioSciences Inc., of Mississauga, Ontario, enrolled the first patient in its Phase I/II non-small-cell lung cancer trial of its anti-EGFr monoclonal antibody, nimotuzumab (TheraCIM). The trial will compare the effects of the combination of nimotuzumab with radiation against radiation alone in patients with Stage IIb and III disease who are found to be insufficiently fit to tolerate the standard of care, or who are not amenable to treatment with curative intent.