Oxigene Inc. reported a radical restructuring to conserve resources and focus on earlier stage programs. The company will conclude its Phase II trial of Zybrestat in non-small-cell lung cancer (NSCLC), and defer initiation of Phase III registration studies of the drug in anaplastic thyroid cancer due to lack of funding. Read More
LONDON – Amsterdam Molecular Therapeutics (AMT) NV is now poised to begin the Phase III extension study of Glybera, its gene therapy treatment for lipoprotein lipase deficiency, and is paring back expenditure as it awaits a response from the European Medicines Agency (EMA) to its request for a re-examination of the Glybera file. Read More
Scientists reported this week that they have developed a novel way to drive cancer cells to suicide: by delivering what they termed a "gene circuit" that sensed the levels of half a dozen miRNAs and, if they matched the expected profile for cancer cells, induced expression of a protein that drove the cells to apoptosis. Read More
AiCuris GmbH & Co. KG gained FDA fast-track designation – and valuable mindshare – for its lead drug AIC246 (letermovir), a viral terminase inhibitor that combats human cytomegalovirus (CMV) infection. It is currently undergoing a Phase IIb trial in bone marrow transplant recipients, who are receiving the drug prophylactically, in order to prevent the dormant virus from re-emerging and causing active infection. Read More
StemCells Inc., of Newark, Calif., said the California Institute of Regenerative Medicine approved the firm's application of a planning grant of $100.000, which will help fund the development of human neural stem cell product HuCNS-SC cells in Alzheimer's disease by enabling StemCells and its collaborators at the University of California, Irvine, to prepare and submit for a Disease Team Therapy Development Research Award, which could bring the firm up to $20 million over four years to support preclinical and investigational new drug application-enabling activities. Read More
MorphoSys AG, of Martinsried, Germany, said it dosed the first patient in a Phase I/IIa trial testing the safety and preliminary efficacy of anti-CD38 cancer antibody MOR202 in patients with relapsed or refractory multiple myeloma. The study is expected to enroll a maximum of 82 patients. Read More
