Advanced Tissue Sciences Inc., of La Jolla, Calif., and Smith & Nephew plc, of London, said the FDA approved an application for an amendment to the investigational device exemption for the clinical trial of Dermagraft to treat diabetic foot ulcers. The companies sought the amendment to revise the enrollment criteria and the statistical plan for data analysis based on data presented in December.
Agilent Technologies Inc., of Palo Alto, Calif., expanded its alliance with Rosetta Inpharmatics Inc., of Kirkland, Wash., to include Rosettas FlexJet DNA microarray technology. The expansion follows an earlier agreement in December to develop and distribute Rosettas gene-expression analysis software platform.
Alexion Pharmaceuticals Inc., of New Haven, Conn., said the FDA designated fast-track status for development of Alexions humanized monoclonal antibody C5 complement inhibitor 5G1.1 to treat patients with the kidney disease known as membranous glomerulonephritis.
AltaRex Corp., of Waltham, Mass., closed a private placement of special warrants resulting in gross proceeds of C$6 million (US$4.14 million). About 60 percent of the offering was purchased by a group of existing institutional shareholders. AltaRexs chairman and senior management team purchased about 15 percent. Net proceeds will go toward funding OvaRex MAb, which is in late-stage clinical development for ovarian cancer.
Ariad Pharmaceuticals Inc., of Cambridge, Mass., said it developed of a new class of small-molecule drugs that inhibit the breakdown of bone resulting in osteoporosis. A research paper describes the new class in the March 2000 issue of Chemistry & Biology. This is the first publication of a selective small-molecule drug that targets Src tyrosine kinase, the company said.
Celgene Corp., of Warren, N.J., said results of its initial Phase I studies of the first two compounds from its proprietary class of immunomodulatory drugs showed the drugs were well tolerated in healthy volunteers. No serious adverse events were reported in the double-blind, placebo-controlled trials. Each drug was administered orally in a single, ascending dose in 30 subjects.
Cell Pathways Inc., of Horsham, Pa., and Eli Lilly & Co., of Indianapolis, will cooperate in supporting trials to investigate the therapeutic potential of Aptosyn (exisulind) in combination with Gemzar (gemcitabine). The trials will test whether the combination is useful in the treatment of pancreatic, non-small-cell lung and bladder cancers. Gemzar is approved in the U.S. to treat pancreatic cancer and in combination with cisplatin to treat non-small-cell lung cancer. Aptosyn is under regulatory review in the U.S. as a treatment for patients with familial adenomatous polyposis.
ChemDiv Inc., of San Diego, and ChemBlock International, of Moscow, formed a business alliance unifying their small-molecule historical collections. It provides commercial access to more than 220,000 individually synthesized compounds obtained from more than 1,000 academic research laboratories. ChemDiv obtained an exclusive worldwide right for distribution of the joint collection in the framework of its lead generation and rapid analogue delivery programs.
CollaGenex Pharmaceuticals Inc., of Newtown, Pa., said the UKs Medicines Control Agency granted marketing approval for Periostat for the adjunctive treatment of chronic adult periodontitis. The company plans to seek marketing authorizations for a tablet formulation of Periostat in the UK and other countries within the European Union.
Discovery Laboratories Inc., of Doylestown, Pa., received a warrant exercise notice from its largest shareholder, OrbiMed Advisors LLC, of New York. Proceeds from the transaction will total $2.2 million.
Epimmune Inc., of San Diego, said it identified a novel vaccine candidate for the prevention and treatment of hepatitis C. The company uses epitopes, small fragments from protein antigens that trigger an immune response, in its approach to vaccine development. The companys stock (NASDAQ:EPMN) closed Tuesday at $12.125, up $4, or about 49 percent.
Gene Logic Inc., of Gaithersburg, Md., said it completed the worlds first comprehensive survey of human gene expression across the 40 major normal tissue types. The combination of the sequences of the human genes and the knowledge of when and where these genes are active is being used by the companys customers to accelerate drug discovery and development efforts. Gene Logics stock (NASDAQ:GLGC) closed Tuesday at $119.375, up $12.875, or about 12 percent.