¿ Avant Immunotherapeutics Inc., of Needham, Mass., began a placebo-controlled Phase II study of its cholesterol management vaccine (CETi-1) in about 200 patients with low levels of high-density lipoprotein cholesterol. The study will evaluate the safety, immunogenicity and dose-response relationship of the product in patients who receive an initial immunization followed by boosters. The principal endpoint is the change in HDL cholesterol measured after the six-month booster. CETi-1 is designed to raise serum HDL cholesterol levels by blocking the transfer of cholesterol from HDL to low-density lipoprotein.
¿ AVAX Technologies Inc., of Kansas City, Mo., said it submitted its response to the FDA¿s written notifications related to the clinical holds on AVAX¿s M-Vax and O-Vax autologous cancer vaccine clinical trials. The reply addressed the issues of sterility, handling of tumor cells, the preparation of vaccines by the company and its manufacturing practices, including successful validation of the aseptic full process. The FDA will have at least 30 days to review the submission. (See BioWorld Today, April 24, 2001.)
¿ Avigen Inc., of Alameda, Calif., said the first patient was treated Monday in a second Phase I trial using its gene therapy product for hemophilia B. Patients will receive Avigen¿s adeno-associated virus vector containing the Factor IX gene, Coagulin-B, via infusion into the hepatic artery. The trial is being conducted at the Children¿s Hospital of Philadelphia and Stanford University Medical Center.
¿ Biogen Inc., of Cambridge, Mass., said research by its scientists published Thursday in the journal Science offers insights into the mechanism and possible treatment of autoimmune diseases. The studies present new information about B-cell activating factor on the TNF family, a protein central to normal B-lymphocyte development. The research was led by Christine Ambrose, Jeffrey Thompson and Martin Scott.
¿ BioReliance Corp., of Rockville, Md., agreed to produce clinical supplies of herpes simplex virus-derived G207 and NV1020 for MediGene Inc., of San Diego, a wholly owned subsidiary of MediGene AG, of Martinsried, Germany. MediGene Inc. will develop both products. BioReliance will provide manufacturing and testing services for the products and production will occur in BioReliance¿s facility in Rockville. Financial terms were not disclosed.
¿ BTG plc, of London, acquired Bilosomes, an oral vaccine delivery vesicle that protects antigens from the digestive process and also can act as an immunological adjuvant. BTG is seeking to license the technology and develop it further. The technology has been tested using influenza and measles antigens, but has possible applications in the oral delivery of both human and veterinary vaccines, the company said.
¿ Celera Genomics Group, of Rockville, Md., signed a multiyear collaboration with SomaLogic, of Boulder, Colo., giving Celera access to aptamers and aptamer arrays developed through SomaLogic¿s Selex process and provides SomaLogic access to sequencing and proteins for developing aptamers. SomaLogic¿s aptamer technology is based on the use of nucleic acids that bind to proteins with specificity and sensitivity. Financial terms were not disclosed.
¿ Enzon Inc., of Piscataway, N.J., filed a registration statement related to its $400 million principal amount of 4.5 percent convertible subordinated notes due 2008, initially sold in June. When declared effective, the statement will be available to use for resales of Enzon¿s notes and the shares of Enzon common stock issuable upon conversion of the notes by holder¿s thereof. (See BioWorld Today, June 15, 2001.)
¿ Genaera Corp., of Plymouth Meeting, Pa., initiated its first clinical trial for testing its mucoregulator compound, Lomucin, intended to block the hCLCA1-dependent mucus overproduction present in asthma. The trial is being conducted with collaborators in Mexico City. An investigational new drug application is planned for the United States in 2002.
¿ Hyseq Inc., of Sunnyvale, Calif., entered a research and development collaboration with the pharmaceutical division of Kirin Brewery Co. Ltd., of Tokyo. Kirin will fund three years of collaborative research work at Hyseq and both companies will conduct research directed toward discovering proteins and antibodies for diseases, including hematopoietic and inflammatory diseases. Discoveries will be jointly owned by the companies, and will be jointly developed and marketed with costs, efforts and revenues shared. Hyseq will have marketing rights in North America and Kirin will have marketing rights in Asia, New Zealand and Australia. For the rest of the world, rights will be shared.
¿ InterMune Inc., of Brisbane, Calif., accepted a humanized monoclonal antibody targeted against the PcrV protein of the bacterium Pseudomonas aeruginosa. The monoclonal form was developed by a team of researchers at the Medical College of Wisconsin in Milwaukee and the University of California, San Francisco, then humanized under an agreement with Protein Design Labs Inc., of Fremont, Calif. InterMune said it expects to move the program into the clinic by the end of next year.
¿ Orchid BioSciences Inc., of Princeton, N.J., said the cystic fibrosis genetic screening test, Elucigene CF29, was launched for use by CLIA-approved laboratories in the United States. The Elucigene CF29 panel of Analyte Specific Reagents includes all 25 mutations recommended by the American College of Medical Genetics for cystic fibrosis screening, the company said. Orchid develops and manufactures a range of assays for the determination of cystic fibrosis status.
¿ Rubicon Genomics Inc., of Ann Arbor, Mich., appointed Ernest Ludy chairman, as well as electing Roger Newton to its board. Ludy is the founder and former chairman and CEO of The Medstat Group, a publicly traded health care information company. Also, he serves on the Gerald R. Ford School Committee at the University of Michigan.
¿ Transkaryotic Therapies Inc., of Cambridge, Mass., said the Norwegian Medicines Agency granted marketing authorization of Replagal (agalsidase alfa) enzyme replacement for Fabry¿s disease. The approval is based on six-month data from two independent clinical trials conducted in the United States and the United Kingdom, as well as long-term data of 18 months from an open-label maintenance study. TKT received European Commission approval for the 15 European Union members in early August. (See BioWorld Today, Aug. 6, 2001.)
¿ Versicor Inc., of Fremont, Calif., said it achieved a fourth milestone in its ongoing three-year collaboration with Novartis Pharma AG, of Basel, Switzerland, for the transfer of a proprietary assay package to identify antibacterial agents. Novartis will use the assay in its high-throughput screening lab to identify new anti-infective drugs. The companies began the collaboration, valued at up to $38 million in 1999. (See BioWorld Today, April 2, 1999.)