o Avanir Pharmaceuticals Inc., of San Diego, filed a formal request for a meeting with the FDA regarding additional data the agency requested before it will approve docosanol, a topical treatment for oral herpes. The FDA previously agreed to meet with Avanir within 30 days of such a request. The drug was deemed not approval last month. (See BioWorld Today, Dec. 28, 1998, p. 1.)
o Dusa Pharmaceuticals Inc., of Toronto, said 1.5 million shares were sold at US$5 each in a private placement that grossed US$7.5 million. The shares were discounted 15.6 percent to the average closing price over the past six weeks.
o Epimmune Inc., a majority-owned subsidiary of San Diego-based Cytel Corp., said data from two HIV-related animal models provided further support that epitope-based vaccines hold promise for controlling HIV infection. A monkey study produced significant cytotoxic T-cell (CTL) response in all animals. In transgenic mice, the EpiGene construct induced potent responses to multiple CTL epitopes.
o Fujisawa Healthcare Inc., of Deerfield, Ill., reported that the FDA's Oncologic Drugs Advisory Committee recommended against approval of Prograf (tacrolimus, FK506) following allogeneic bone marrow transplantation procedures involving either matched sibling donor transplants or unrelated donor transplants. The committee recommended that Fujisawa conduct another study to clarify open questions it had concerning the submitted data.
o ICOS Corp., of Bothell, Wash., said IC351, a phosphodiesterase 5 inhibitor being developed for erectile dysfunction with Eli Lilly and Co., of Indianapolis, demonstrated statistically significant improvements in sexual response as compared to placebo in two Phase II trials. The company also started trials with IC14, an antibody that blocks the CD14 receptor and is being developed for sepsis.
o Igen International Inc., of Gaithersburg, Md., and the John Wayne Cancer Institute, of Santa Monica, Calif., reported the institute's Dave Hoon developed a novel diagnostic test for various cancers based on Igen's Origen technology. Hoon developed a simple, ultra-sensitive blood test for early detection of micrometastases in cancer patients that can aid physicians in determining the best treatment.
o IntraBiotics Pharmaceuticals Inc., of Mountain View, Calif., started a Phase II trial of ramoplanin ointment, a treatment designed to prevent hospital-based infections due to Staphylococcus aureus. Nine sites will enroll a total of 250 patients who carry Staphylococcus aureus in their nose. Ramoplanin is a naturally occurring antibiotic that rapidly kills Gram-positive types of bacteria by inhibiting one of the enzymes needed to construct the bacterial cell wall.
o Neose Technologies Inc., of Horsham, Pa., expanded its November 1997 agreement with McNeil Specialty Products Co., a subsidiary of New Brunswick, N.J.-based Johnson & Johnson. J&J will make a $4 million equity investment in Neose. The companies are developing manufacturing technologies for complex carbohydrates, and plan to build a manufacturing facility capable of producing at least one product within a year.
o Onyx Pharmaceuticals Inc., of Richmond, Calif., began a Phase I/II trial of its lead anticancer agent, ONXY-015, using intra-arterial administration in patients with colorectal cancers that have spread to the liver. The trial will involve ONYX-015 as both a single agent and in combination with standard chemotherapy regimens.
o OrthoLogic Corp., of Tempe, Ariz., exercised an option to license U.S. rights for Chrysalin, a tissue-repair synthetic peptide targeted for fresh fracture indications. OrthoLogic gained rights to orthopedic applications through an investment in Galveston, Texas-based Chrysalis BioTechnology Inc.
o Sangamo BioSciences Inc., of Point Richmond, Calif., signed a research agreement with DuPont Pharmaceuticals Co., of Wilmington, Del., under which DuPont will provide undisclosed funding in exchange for use of Sangamo's Universal GeneTools technology. It will be used to identify and validate novel gene targets for drug discovery.
o Synsorb Biotech Inc., of Calgary, Alberta, entered into a collaboration with Ocean Pharmaceuticals Inc., of White Rock, British Columbia, to develop antibiotic therapies for bacterial and fungal infections. Synsorb will provide financial and technical support through early preclinical research, then acquire rights to the compounds.