• Affymax, Inc., of Palo Alto, Calif., initiated a clinical trial to evaluate the use of Hematide to treat anemia in chronic kidney disease patients with pure red-cell aplasia. PRCA, a rare autoimmune disorder, occurs when the body produces neutralizing antibodies to recombinant human erythropoietin, thus suppressing the production of red blood cells by the bone marrow. Hematide is a synthetic, peptide-based, erythropoiesis-stimulating agent being evaluated in Phase II trials to treat anemia in patients with CKD and cancer.
• Amicus Therapeutics, of Cranbury, N.J., said the Committee for Orphan Medicinal Products of the European Medicines Agency recommended orphan medicinal product designation for Amigal, or migalastat hydrochloride. Amigal is being developed as an oral therapy for the treatment of Fabry disease, a lysosomal storage disorder caused by an enzyme deficiency that leads to pain, kidney failure and an increased risk of heart attack and stroke. Amigal currently is being studied in Phase II trials in the U.S., the UK, Brazil and Australia. The recommendation now goes to the European Commission for approval.
• Chiron Corp., of Emeryville, Calif., began a Phase I trial of CHIR-265, a selective Raf kinase inhibitor, in patients with melanoma - a disease associated with a high percentage of Raf mutations. The single-agent, open-label trial is designed to evaluate the small molecule's safety, tolerability and pharmacokinetic profile. A translational medicine approach will be used to monitor biomarkers in order to evaluate the biological activity and define the optimal dose. The study is expected to enroll up to 60 patients at three U.S. cancer centers.
• Generex Biotechnology Corp., of Toronto, said interim three-month results of a six-month trial involving 24 adolescents and five young adult patients with Type I diabetes showed that replacing just one daily injection of regular insulin with Generex Oral-lyn during the day improved parameters of metabolic control in the same manner observed with intensively monitored standard therapy. Generex and its partners have designed studies using larger numbers of Type I diabetes subjects.
• Pharmaxis Ltd., of Sydney, Australia, said it completed enrollment in its clinical trial to test Aridol's ability to predict response to treatment in patients with chronic obstructive pulmonary disease. The trial commenced in September 2005 and is being conducted at 11 hospitals in Australia. Patients who volunteer for the trial receive an Aridol test followed by 12 weeks of treatment with an inhaled steroid to control lung inflammation. Data from the study are expected to be available in the third quarter.
• Salix Pharmaceuticals Ltd., of Raleigh, N.C., said the FDA issued an approvable letter for MoviPrep (PEG 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid for oral solution), a product under review as a bowel cleansing agent prior to colonoscopy. Approval is contingent upon the resolution of certain manufacturing deficiencies, and the company said it is working to resolve those issues with the product's innovator, Norgine BV, of Amsterdam, the Netherlands. Salix, which has an exclusive U.S. rights to the product, said it still expects to launch it this year.