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.
has initiated a Phase I clinical trial for VX-950, an investigational oral
protease inhibitor for the treatment of hepatitis C virus infection.
has initiated a global Phase III study of mycophenolate mofetil (CellCept)
for myasthenia gravis.
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
has initiated a Phase II clinical trial of its proprietary lead product, A6,
for the prevention of clinical relapse in patients with ovarian cancer.
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 infarctiontreated with primary percutaneous intervention.
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.