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Clinic Roundup
(BioWorld Today Via Acquire Media NewsEdge) , of Redwood City, Calif., completed enrollment in a Phase III trial comparing APF530 (sustained-release granisetron) to Aloxi (palonosetron hydrochloride, Eisai Co. Ltd.) in chemotherapy-induced nausea and vomiting. Results are expected in the second half of the year.
? Andromeda Biotech Ltd., of Rehovot, Israel, said its Phase III trial of peptide DiaPep 277 for Type 1 diabetes will continue as planned following an interim analysis. The interim analysis triggers an option for Jerusalem-based Teva Pharmaceutical Industries Ltd. to increase its investment in Andromeda, which is a wholly owned subsidiary of investment group Clal Biotechnology Industries Ltd. (See BioWorld Today, Dec. 4, 2007.)
? Canopus BioPharma Inc., of Los Angeles, received clearance from the South African Medicines Control Council to initiate a Phase II trial evaluating the ability of CB1400 to protect the gastrointestinal tract from radiation-induced mucositis.
? Dyax Corp., of Cambridge, Mass., completed the patient treatment phase of its second Phase III trial of DX-88 (ecallantide) in hereditary angioedema. DX-88 is a recombinant plasma kallikrein inhibitor and generated positive data in its first Phase III trial. Dyax said complications with its clinical research provider will delay the release of the data and the expected completion of the DX-88 rolling biologics license application until early in the fourth quarter.
? MediciNova Inc., of San Diego, said it initiated dosing in a second Phase II trial to determine the safety and efficacy of MN-221, a highly selective beta2-adrenergic receptor agonist, in patients with moderate to severe, but stable asthma. In the randomized, open-label, placebo-controlled trial, 15 to 25 patients will receive MN-221 at doses of up to 1,125 mcg or placebo in a continuous intravenous infusion for up to two hours. Safety and preliminary efficacy data will be collected and summarized and, along with data from the other Phase II trial in severe, acute exacerbations of asthma, will aid in the design of a larger Phase IIb emergency department trial expected to begin at the end of this year.
? Neose Technologies Inc., of Horsham, Pa., and BioGeneriX AG, of Mannheim, Germany, initiated a Phase II trial of GlycoPEG-GCSF for neutropenia associated with myelosuppressive chemotherapy. The randomized, double-blind trial will compare GlycoPEG-GCSF to Neulasta (pegfilgrastim, Amgen Inc.) in 200 breast cancer patients receiving myelosuppressive CTX chemotherapy. Data are expected in the first half of 2009.
? Saladax Biomedical Inc., of Bethlehem, Pa., presented data from a multicenter trial showing that its nanoparticle-based immunoassay, called 5-FU Personalized Chemotherapy Management, performed as well as high performance liquid chromatography or liquid chromatography-mass spectrometry, but was easier to use, more rapid and more amenable to widespread clinical use. The new blood test may make it easier for oncologists to accurately measure and personalize 5-fluorouracil dosing for patients undergoing continuous infusion chemotherapy regimens.
? Tranzyme Pharma Inc., of Durham, N.C., announced positive results from its QT/QTc study of ghrelin agonist TZP-101. The double-blind, randomized, parallel study was conducted to evaluate the cardiac safety of TZP-101, with a focus on cardiac repolarization as measured by the duration of the QT interval in serial electrocardiograms (ECG). Data showed that TZP-101 has no effect on the ECG profile and is therefore safe.
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