Drug Criteria & Outcomes

  • Chiron Corp. has initiated a new Phase II study of aldesleukin (Proleukin) interleukin-2 (IL-2) plus rituximab in rituximab-naive patients with low-grade non-Hodgkin’s lymphoma to determine the combination’s potential in patients receiving rituximab for the first time.
  • Vertex Pharmaceuticals has initiated a Phase I clinical trial for VX-950, an investigational oral protease inhibitor for the treatment of hepatitis C virus infection.
  • Aspreva Pharmaceuticals has initiated a global Phase III study of mycophenolate mofetil (CellCept) for myasthenia gravis.
  • Peninsula Pharmaceuticals has announced that patient enrollment has begun in the fifth pivotal Phase III trial of its lead product candidate, doripenem for injection, in patients with hospital-acquired pneumonia.
  • Medarex has announced that under the U.S. Orphan Drug Act, the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Medarex’s fully human anti-CTLA-4 antibody, MDX-010, for the treatment of high-risk Stage II, Stage III, and Stage IV melanoma.
  • Array BioPharma has initiated a Phase I clinical trial for its small molecule anticancer compound, ARRY-142886 (AZD6244).
  • Angstrom Pharmaceuticals has initiated a Phase II clinical trial of its proprietary lead product, A6, for the prevention of clinical relapse in patients with ovarian cancer.
  • Alexion Pharmaceuticals has announced that it and its collaboration partner for pexelizumab, Procter & Gamble Pharmaceuticals, have received written confirmation from the FDA indicating agreement with the protocols for two independent Phase III trials of the investigational drug. One Phase III protocol covers patients undergoing coronary artery bypass graft surgery and the second covers a separate program in patients experiencing acute myocardial infarction treated with primary percutaneous intervention.
  • Valeant Pharmaceuticals has begun the second of two global Phase III clinical trials for its antiviral compound, Viramidine, a nucleoside (guanosine) analog. The compound is being studied in oral form for the treatment of chronic hepatitis C in conjunction with a pegylated interferon.
  • CoTherix has begun a Phase II trial of iloprost inhalation solution (Ventavis) in combination with bosentan (Tracleer) in patients with pulmonary arterial hypertension.
  • InterMune has initiated the DIRECT Trial, a Phase III clinical trial designed to evaluate the safety and efficacy of daily Interferon alfacon-1 (Infergen) in combination with ribavirin for the treatment of patients chronically infected with hepatitis C virus (HCV) who have failed to respond to a previous course of therapy with pegylated interferon alfa-2 plus ribavirin.
  • Xanthus Life Sciences has initiated Phase I clinical trials for Symadex (formerly C-1311) in patients with advanced solid tumors.
  • Advanced Magnetics has initiated a Phase III multicenter study for ferumoxytol, the company’s investigational intravenous iron replacement therapeutic. The study is a Phase III clinical trial in anemic chronic kidney disease patients who are on hemodialysis.
  • Pharmacyclics is enrolling patients in a multicenter Phase II clinical trial of motexafin gadolinium (Xcytrin) Injection, the company’s lead cancer therapeutic candidate, for the treatment of patients with recurrent low-grade non-Hodgkin’s lymphoma.
  • deCODE genetics has completed enrollment for its 10-week Phase IIa clinical trial of DG031, its developmental compound for the prevention of heart attack. The trial is designed to examine the effect of various doses of DG031 on biomarkers such as C-reactive protein and myeloperoxidase and on the production of leukotrienes.
  • Therion Biologics Corp. has initiated a Phase III clinical trial for Panvac-VF, Therion’s lead vaccine candidate, for the treatment of metastatic pancreatic cancer in patients who have not responded to treatment with gemcitabine.
By Jennifer Herring, PharmD Candidate, Harrison School of Pharmacy, Auburn (AL) University.