Aastrom Biosciences Inc., of Ann Arbor, Mich., received CE mark approval for the DCV-I Cell Therapy Kit, which provides the automated GMP-compliant production of a complete antigen-loaded dendritic cell vaccine, based on Aastrom’s cultured dendritic cell, the Dendricell. Zellera AG, Aastrom’s subsidiary located in Berlin, will lead the sales and marketing efforts in Europe while Aastrom handles the United States.
Biosite Inc., of San Diego, is implementing new antibody-expression technology that is being used with its Omniclonal phage display technology to select and express antibodies. The technology is intended to allow Biosite the freedom to operate its business without using patents licensed from XOMA Ltd., of Cambridge, Mass.; their dispute stems from patents licensed by Biosite in 1998 and 1999. In May, XOMA claimed Biosite was in breach of its license agreements and Xoma tried to terminate the license, which led to continuing litigation between the two companies. Biosite also is employing its new technology in collaborations with Medarex Inc., of Princeton, N.J., and third-party partners.
Celera Genomics Group, of Rockville, Md., an Applera Corp. business, said the Institute for OneWorld Health (IOWH), of San Francisco, and the National Institutes of Health, of Bethesda, Md., initiated development of CRA-3316 as a potential new treatment for Chagas’ disease. CRA-3316 is a cysteine protease inhibitor, for which Celera has given IOWH the exclusive license to develop for parasitic infections in humans. IOWH will sponsor development activities, including production of drug substance, investigational new drug application-enabling safety studies, and Phase I trials. IND-enabling studies of CRA-3316 are under way with a goal of moving the compound into the clinic in 2002.
Ciphergen Biosystems Inc., of Fremont, Calif., signed a Collaborative Research and Development Agreement with the Laboratory of Immunoregulation at the National Institute of Allergy and Infectious Diseases, of Bethesda, Md. The NIAID and Ciphergen will work to discover CD8+ T cell-derived antiviral factors, using Ciphergen’s ProteinChip Biomarker System. The company also signed a Research and License Agreement with the Aaron Diamond AIDS Research Center to pursue projects related to discoveries and samples provided by the center, as well as joint discoveries. Ciphergen retains therapeutic and diagnostic rights to discoveries made under the collaboration, with royalties paid back to Aaron Diamond.
Cubist Pharmaceuticals Inc., of Lexington, Mass., reported preliminary results from a 68-patient Phase II feasibility trial investigating the safety and efficacy of its antibiotic Cidecin (daptomycin for injection) in the treatment of complicated urinary tract infection caused by Gram-positive bacteria. The trial was a randomized, open-label, microbiologist- and evaluator-blinded multicenter study conducted mainly in Eastern Europe. In the microbiologically evaluable population, Cidecin was 83 percent effective while 94 percent effective when judged clinically. In the comparator arm, Cipro achieved 85 percent microbiologic success and 93 percent clinical success.
Cypress Bioscience Inc., of San Diego, said an article authored by Cypress employees is featured in the winter 2002 volume of Psychopharmacology Bulletin. The review summarizes the understanding of the pathophysiology of FMS, a condition characterized by pain and stiffness throughout the body, accompanied by headache and fatigue. The article includes a review of clinical literature supporting the use of pharmaceutical agents to treat the condition. Cypress is developing milnacipran, an approved antidepressant in 13 countries, for the treatment of FMS.
NeoPharm Inc., of Lake Forest, Ill., was granted orphan drug status by the FDA for the company’s antimesothelin monoclonal antibody toxin, SS1-PE38, for the treatment of mesothelioma and ovarian cancer. NeoPharm exclusively licensed SS1-PE38 from the National Cancer Institute, of Bethesda, Md., and is developing it under a Cooperative Research and Development Agreement with NCI. SS1-PE38 targets the mesothelin antigen on tumor cells, delivering the cytotoxin PE38.
Genelabs Technologies Inc., of Redwood City, Calif., said a research paper describing its antibacterial compounds was published in Feb. 14 issue of the Journal of Medicinal Chemistry. The paper describes the discovery and structure-activity relationships of a group of pyrrole tetraamides. The paper also describes certain compounds of this class having antibacterial activity in vitro against various Gram-positive bacteria, including vancomycin-resistant Enteroccoci and methicillin-resistant Staphylococcus aureus. The paper was authored by Genelabs scientists, the company said.
Genzyme Biosurgery, a division of Genzyme Corp., of Cambridge, Mass., said orthopaedic surgeons presented three papers describing the long-term outcomes of patients receiving Carticel, Genzyme Biosurgery’s autologous cultured chondrocytes product, at the annual meeting of the American Academy of Orthopaedic Surgeons, held in Dallas. Surgeons described five-year results from the first 100 patients treated with Carticel to repair damaged cartilage on the thighbone part of the knee; the potential of Carticel in treating injuries to the trochlea; and results of Carticel compared with marrow-stimulation techniques. Carticel was approved by the FDA in August 1997 for the repair of symptomatic cartilaginous defects of the femoral condyle caused by acute or repetitive trauma in patients who have had an inadequate response to a prior arthroscopic or other surgical-repair procedure.
Hollis-Eden Pharmaceuticals Inc., of San Diego, signed a Cooperative Research and Development Agreement with the Uniformed Services University of the Health Sciences, of Bethesda, Md., and the Henry M. Jackson Foundation for the Advancement of Military Medicine Inc., of Rockville, Md. The agreement provides for joint development of Hollis-Eden’s HE2100 for use in the area of radiation protection. Hollis-Eden retains all rights to HE2100, including rights to supply it to the U.S. government. Financial details were not disclosed.
NicOx SA, of Sophia Antipolis, France, reported positive clinical results of a 32-patient Phase I study with NCX 1015, its nitric oxide-releasing derivative of prednisolone, in development to treat inflammatory bowel disease. The randomized, double-blind, placebo-controlled, parallel-group study evaluated four single escalating doses of NCX 1015 in young, healthy male volunteers. The highest dose corresponded to about 40 mg of prednisolone. Based on the findings, as well as preclinical results published in this month’s Proceedings of the National Academy of Sciences, NicOx plans to expand development of the compound, including an oral formulation.
Organon Inc., of West Orange, N.J., and Sanofi-Synthelabo, of Paris, said Arixtra 2.5 mg injection, a synthetic selective Factor Xa inhibitor, is available in the United States to help prevent deep-vein thrombosis, a condition which may lead to pulmonary embolism in patients undergoing hip-fracture surgery, hip-replacement surgery or knee-replacement surgery. The new drug application for Arixtra was submitted in February 2001 and given priority review by the FDA. Approval was based on results from more than 7,000 patients worldwide.
Phase-1 Molecular Toxicology Inc., of Santa Fe, N.M., said it identified sets of genes that predict toxicology endpoints in rats. Using its in vivo TOXbank Rat Database, Phase-1’s data-mining team identified small sets of biomarker genes. The biomarkers will allow scientists to use gene expression profiles to predict potential toxicity for lead compounds, the company said. Phase-1’s products and services employ gene expression technologies, toxicogenomics and bioinformatics.
Sequenom Inc., of San Diego, opened its Asia-Pacific headquarters in Queensland, Australia. In addition to regional operations and distribution, Sequenom’s Asia-Pacific headquarters will support regional customers that have chosen the company’s high-throughput MassArray system. Sequenom uses a population genetics approach to identify potential disease-related genes that affect significant portions of the overall population.
The University of Pennsylvania School of Medicine, of Philadelphia, said its scientists found a mechanism that sets human growth hormone (hGH) in action. Using transgenic mice, researchers pinpointed the activation mechanism at a location called hypersensitive site 1. The distance between hGH and its activation site indicates the presence of an intervening gene. The results were published in Thursday’s edition of Molecular Cell.