• Flamel Technologies SA, of Lyon, France, entered into an agreement with Wyeth Pharmaceuticals, of Collegeville, Pa., for development and licensing of a marketed protein to be delivered using Flamel's Medusa technology. Flamel will receive an up-front payment and potential development fees, milestones and royalty payments, the terms of which were not disclosed. The Medusa technology is designed to deliver controlled-release formulations of therapeutic proteins and peptides and other molecules, without reducing bioactivity.
• Genmab BV, of Utrecht, the Netherlands, extended the use of Guildford, UK-based ID Business Solutions Ltd.'s ActivityBase Xtended Edition within its Hybridoma Discovery department. Genmab initially purchased the program in 2006 to handle the design, capture, storage and retrieval of its plate-based screening data, and ActivityBase XE allows the company to capture, validate and visualize data from antibody screening in a contextually rich environment. Financial terms were not disclosed.
• Immutep SA, of Orsay, France, published data showing its lead product, IMP321, induces activation of a range of human effector cytotoxic cells. The product, ImmuFact IMP321, is a natural human immunostimulatory factor designed to amplify the T-cell immune response. Research data showed the principal antitumor immune response is mediated through the activation of Type I cytotoxic CD8+ T cells, NK cells and monocytes/macrophages. Data were published in the Journal of Immunology.
• NicOx SA, of Sophia Antipolis, France, said Topigen Pharmaceuticals Inc., of Montreal, plans to initiate a Phase II study for the use of its TPI-1020 compound to treat chronic obstructive pulmonary disease. The study, which Topigen expects to launch during the second half of this year, follows promising top-line results from an initial Phase II study with the compound, a respiratory anti-inflammatory treatment licensed from NicOx.
• Phynova Group plc, of Oxford, UK, a developer of prescription pharmaceuticals derived from Chinese botanical medicines, said it completed patient enrollment in a Phase I/II clinical trial of PYN17 in five hepatology centers in the U.S. PYN17 is used for treating liver inflammation in chronic hepatitis C. The double-blind trial has enrolled 39 patients as planned, randomized to treatment with either PYN17 or placebo. No serious adverse events had been reported to date.
• S*BIO Pte. Ltd., of Singapore, said it is developing an orally administered compound, SB1518, in myeloproliferative disorders (MPD) and certain hematological malignancies. SB1518 is a small-molecule JAK2-selective kinase inhibitor that has shown activity against both the wild-type JAK2 kinase and the JAK2 kinase with the activating V617F mutation that is found frequently among three types of MPD and in some leukemias. It previously showed antiproliferative and antitumor activity, along with good tolerability, in in vitro and in vivo models.
• Silence Therapeutics plc, of London, an RNAi therapeutics company, said its lead compound, Atu027, successfully completed preclinical, 28-day toxicology studies. Silence Therapeutics has identified a dose range for Atu027, a systemically delivered RNAi compound. Additional preclinical studies will be conducted prior to an application in 2008 to carry out a clinical trial.
• SuppreMol GmbH, of Martinsried, Germany, was granted orphan designation in the European Union for SM101, a recombinant human soluble Fc-gamma receptor IIb, for treating idiopathic thrombocytopenic purpura. Phase I studies are expected to begin in the second half of 2008.
• SkyePharma plc, of London, said the company met with the FDA and agreed on the additional clinical work required for its combination asthma treatment Flutiform. Work will include a further study to provide more efficacy data. Discussions are ongoing on the design of the study. The anticipated date for filing of a Flutiform new drug application remained in the second half of 2008, while the cost for the additional work is expected to be $6 million to $10 million.
• Tissue Regenix Ltd., of Leeds, UK was awarded a £420,000 (US$840,000) grant by the UK Department of Health to support a three-year, £1 million project to develop small- and medium-diameter vascular grafts. The collaboration between the company, NHS Blood and Transplant and the Institute of Medical and Biological Engineering at the University of Leeds will address the need for an off-the-shelf supply of functional arterial conduits for vascular surgery. The project will combine Tissue Regenix's tissue processing and decellularization technologies with the tissue-banking and processing expertise of NHS Blood and Transplant and the tissue-engineering expertise of the university.
• Vernalis plc, of Winnersh, UK, announced the results of its Phase I program for the CB1 antagonist V24343, which has completed two Phase I studies, a single and multiple ascending-dose study for up to 14 days, and a food effect study. There was striking weight loss over 16 days in 66 overweight and mildly obese volunteers, the company said. The product generally was well tolerated with no serious adverse events, and efficacy also was demonstrated by clinically relevant reductions in body fat, energy intake and waist circumference. The company has said it is seeking a partner for the product.
• Vivalis, of Nantes, France, and Innate Pharma SAS, of Marseille, France, launched a collaboration to evaluate Vivalis' EBx cell lines, derived from avian (duck) embryonic stem cells, for the production of monoclonal antibodies. Innate will compare production of its monoclonal antibody in EBx and CHO cells, looking at the glycosylation profile and cytotoxic activity. Terms of the deal were not disclosed.