Advanced Polymer Systems Inc., of Redwood City, Calif., said its partner, Dermik Laboratories Inc., of Collegeville, Pa., submitted a new drug application for 5-fluorouracil for the treatment of actinic keratoses.
Aurora Biosciences Corp., of San Diego, said Bristol-Myers Squibb Pharmaceutical Research Institute, of Wallingford, Conn., installed and accepted the second module of Aurora's ultra-high throughput screening system (UHTSS). The third and final UHTSS module is scheduled for completion by the end of this year. The company expects to bring its customers' systems on line in 2000 and 2001.
Avanir Pharmaceuticals, of San Diego, said the FDA provided preliminary results of the company's appeal of its new drug application for docosanol 10 percent cream, which was rejected in December. At a teleconference, Janet Woodcock, director of the Center for Drug Evaluation and Research, said the company's clinical data on the effectiveness of docosanol in treating recurrent oral-facial herpes is sufficient for approval pending an acceptable audit of the data in one of the studies presented in an amended NDA submitted in March. She also said Avanir's NDA should be considered as an over-the-counter product and that the company must reach an agreement with the FDA on appropriate labeling. The stock (NASDAQ:AVNR) gained 171 percent to close at 84 cents. (See BioWorld Today, March 19, 1999, p. 1.)
Avigen Inc., of Alameda, Calif., said a single administration of an adeno-associated vector carrying the gene for factor VIII produced physiological levels of biologically active clotting factor in the plasma of animals. The discovery brings the company closer to developing adeno-associated vectors to treat hemophilia A.
BioChem Pharma Inc., of Laval, Quebec, received approval from the Department of Health in Taiwan to market Zeffix (lamivudine) for chronic hepatitis B. The product, discovered by BioChem and marketed by London-based Glaxo Wellcome plc, is indicated for the treatment of patients over age 16 with chronic hepatitis B and evidence of viral replication. It is available in the U.S., Canada, South Korea, Europe and China.
Cellomics Inc., of Pittsburgh, and Schenley Park Research Inc. entered into a collaboration to develop new analytical software products that apply data mining technologies to cell-based data in the life sciences. Cellomics has an option to license from Schenley Park certain data mining tools exclusively for cell analysis.
Digene Corp., of Beltsville, Md., received marketing clearance from the FDA for its Hybrid Capture II Chlamydia Test for the detection of chlamydia trachomatis DNA in cervical specimens. The test is indicated for use in women to identify or confirm the presence of chlamydia. Abbott Laboratories, of Abbott Park, Ill., will distribute the test in the U.S.
ID Biomedical Corp., of Vancouver, British Columbia, closed its private placement of 1.4 million special warrants priced at C$2.50, raising C$3.5 million for the company. IDB expects subscriptions for a further 547,300 special warrants in the coming days, resulting in a total private placement of 1.95 million special warrants for total gross proceeds of C$4.88 million (US$3.33 million). Each special warrant will be exercisable into one common share and one half of one share purchase warrant.
Inex Pharmaceuticals Corp., of Vancouver, British Columbia, received approval from the FDA to begin a pivotal Phase II/III trial to evaluate Onco TCS as a treatment for second-relapsed aggressive non-Hodgkin's lymphoma. The trial will enroll about 100 patients at up to 12 medical centers across North America. (See BioWorld Today, Oct. 4, 1999, p. 2.)
Lorus Therapeutics Inc., of Toronto, completed its acquisition of GeneSense Technologies Inc., also of Toronto. The completion triggers the release of proceeds associated with a C$10 million (US$6.8 million) private placement, which was completed last week.
Micrologix Biotech Inc., of Vancouver, British Columbia, completed its $10.1 million (C$15 million) "bought deal" financing to fund the Phase II trial of MBI 226 for the prevention of catheter-related bloodstream infections and other developmental projects. (See BioWorld Today, Aug. 20, 1999, p. 1.)
Pharmacyclics Inc., of San Antonio, reported results from the lead-in phase of its ongoing randomized Phase III trial of Xcytrin (motexafin gadolinium) injection to treat cancer patients with brain metastases. About 25 patients with brain metastases participated in the open-label lead-in phase of the trial. They received an Xcytrin injection followed by standard whole brain radiation treatment once a day for 10 days. Through MRI scans and other tests, Xcytrin appeared to improve local control in the brain, the company said. Nineteen of the 25 patients maintained or improved their neurocognitive function. MRI scans were available in 19 patients and showed that 13 of those patients experienced at least a 50 percent reduction in tumor volume.
Structural Bioinformatics Inc., of San Diego, said it has validated its computational prediction of the mode of action of inhibitors of a novel human viral enzyme. In its collaboration with BioChem Pharma Inc., of Laval, Quebec, the company found that the NMR structure of an enzyme-inhibitor complex agreed well with models of an inhibitor-complex.
Synsorb Biotech Inc., of Calgary, Alberta, said the final report on the interim analysis of a Phase II trial has confirmed that patients receiving a 16g/day dose of Synsorb Cd experienced an 80 percent reduction in the rate of recurrence of Clostridium difficile-associated diarrhea, compared with the group receiving the placebo. The company expects to begin Phase III tests before the end of 1999. (See BioWorld Today, Sept. 14, 1999, p. 2.)
Vion Pharmaceuticals Inc., of New Haven, Conn., found in preclinical studies that its TAPET vector was useful for delivering therapeutic proteins selectively into tumors. In one armed TAPET strain, researchers noticed a complete tumor regression in an animal tumor model.
Xanthon Inc., of Research Triangle Park, N.C., entered into an engineering design and development agreement with CMED/RELA, a division of Boulder, Colo.-based Colorado MEDtech Inc., for development of the Xanthon Xpression Analysis System for genomic expression analysis in drug discovery applications. The system is scheduled to be introduced in about a year, the company said.