* Advanced Corneal Systems Inc., of Irvine, Calif., began a Phase III study of Vitrase (hyaluronidase), its injectable enzyme to induce clearing of vitreous hemorrhage. The randomized, double-masked study will enroll 800 patients. Vitrase has been granted fast-track status by the FDA. (See BioWorld Today, Oct. 16, 1998, p. 1.)
* Calypte Biomedical Corp., of Berkeley, Calif., entered into an agreement to acquire the assets relating to the Western blot product line for certain infectious diseases, including urine-based and serum-based HIV-1 Western blot products, as well as a confirmatory test for Lyme disease and human T-lymphotropic virus. Under terms of the deal, Calypte will acquire the assets from Cambridge Biotech Corp., of Rockville, Md., a wholly owned subsidiary of bioMerieux Inc., for $500,000 cash, 400,000 shares of Calypte common stock, warrants to acquire 600,000 shares of Calypte common stock at $8 to $12 per share, and a royalty based on product sales.
* Celgene Corp., of Warren, N.J., filed an investigational new drug application with the FDA for its lead Selective Cytokine Inhibitory Drug (SelCID), known as CDC 801, for the treatment of Crohn's disease. Preclinical studies have shown SelCIDs are selective, potent inhibitors of the overproduction of tumor necrosis factor, which causes a destructive immune response implicated in the pathology of several prevalent inflammatory diseases, including Crohn's.
* Ligand Pharmaceuticals Inc., of San Diego, began a Phase II trial of Targretin (bexarotene) capsules for advanced breast cancer. Patients will be placed in three groups, with up to 60 patients per group. All will be evaluated every eight weeks for the first six months, and every 12 weeks thereafter.
* Ribozyme Pharmaceuticals Inc., of Boulder, Colo., and Chiron Corp., of Emeryville, Calif., treated the first subject in a Phase II trial using ribozymes in a gene therapy approach to modify stem cells for HIV therapy. The trial is taking place at the City of Hope National Medical Center, in Los Angeles. The primary endpoints are to test patient tolerability of the bone marrow transplant procedure, to measure the level of re-engraftment of transduced cells, to establish whether there is increased patient survival relative to historical controls, and to determine whether transduced cells exhibit increased survival. Planned enrollment is five patients.