¿ Advanced Tissue Sciences Inc., of La Jolla, Calif., and Smith & Nephew plc, of London, said they have completed enrollment in pivotal clinical trials for Dermagraft for treating diabetic foot ulcers. The company said it expects to submit a premarket approval application to the FDA by the end of the summer.
¿ Antigenic Inc., of New York, reported in the August issue of Nature Immunology that the CD91 receptor has been identified as a heat shock protein receptor. The discovery opens opportunities for the development of small-molecule drugs for cancer, infection and autoimmune diseases.
¿ Antisoma plc, of London, said it will raise about #8.7 million (US$13.2 million) through a private placement of 7.68 new ordinary shares at a price of 117 pence per share. Nomura International, the company's broker, will supervise the placement. The company, which is developing products for cancer, intends to increase the number of products in clinical development from two to four by the end of next year.
¿ Arcaria Inc., of Salt Lake City, said Alexander Kamb was named president and CEO, and accepted the resignation of Scott Salka, who held those positions. Kamb previously was executive vice president and chief scientific officer of the functional genomics company.
¿ Boston Life Sciences Inc., of Boston, said Phase III clinical trial results for Altropane confirmed the diagnostic's ability to recognize Parkinson's movement disorders, including Parkinson's disease, from other movement disorders. Both the specificity and sensitivity endpoints were found to be statistically significant. The company said it will present the data to the FDA, and said there could be no assurance that the data would support filing of a NDA or an approval.
¿ Cell Genesys Inc., of Foster City, Calif., said it amended its shareholder rights plan that was established in 1995, increasing the exercise price of rights to $300. The amended plan also establishes the level of ownership at which rights are triggered at 15 percent, and extends the rights plan through 2010.
¿ EraGen Biosciences, of Alachua, Fla., and Time-Logic Corp., of Incline Village, Nev., said they've agreed to collaborate for the delivery of tools for high-throughput sequence analysis management. The collaboration will combine EraGen's proprietary database and TimeLogic's DeCypher bioinformatics computing system.
¿ Genta Inc., of Lexington, Mass., reported the publication in Clinical Cancer Research of positive data for the company's lead antisense drug, Genasense, used in combination with doxorubicin to treat human breast cancer transplanted into mice. Genasense is in a Phase II trial with dacarbazine as a treatment for advanced melanoma.
¿ Gliatech Inc., of Cleveland, said its scientists will present data to the 18th International Complement Workshop in Snowbird, Utah, showing an anti-complement monoclonal antibody reduces tissue damage in preclinical heart attack models. Gliatech is collaborating with Abgenix Inc., of Fremont, Calif., to develop anti-properdin MAbs.
¿ Incyte Genomics Inc., of Palo Alto, Calif., said it will offer its flagship database, LifeSeq Gold, on the Internet. The database, representative of 90 percent of the human genome, combines transcribed genes and information from the Human Genome Project, including 6 million gene sequences derived from 1,200 separate tissue libraries.
¿ IntraBiotics Pharmaceuticals Inc., of Mountain View, Calif., said it started enrollment for the second and last Phase III clinical trial for Protegrin IB-367, a product candidate designed to reduce symptoms of severe mucositis in patients participating in radiation therapy for head and neck cancers. The first Phase III trial for the drug, a synthetic peptide analogue of a naturally occurring antibiotic from white blood cells of pigs, began earlier this year. (See BioWorld Today, April 5, 2000, p. 1.)
¿ Isis Pharmaceuticals, of Carlsbad, Calif., said mouse trials of an antisense inhibitor of the PTP-1B gene showed statistically significant therapeutic benefits, reducing elevated glucose levels in the blood of diabetic mice to normal levels. Isis plans to begin clinical development of a drug targeting the gene, a phosphatase that negatively regulates insulin receptor signaling.
¿ Micrologix Biotech Inc., said it has completed a Phase I human clinical safety trial on MBI 853NL, an antibiotic designed to combat hospital-acquired infections caused by Staphylococcus aureus. The company plans to initiate the next phase of clinical trials later this year.
¿ Millennium Pharmaceuticals Inc., of Cambridge, Mass., said it has completed its acquisition of Cambridge Discovery Chemistry from Oxford Molecular Group plc, for about $52.7 million. The acquisition adds to Millennium about 85 chemists, who will continue to work at CDC's headquarters in Cambridge, UK. (See BioWorld Today, July 7, 2000, p. 1.)
¿ Organogenesis Inc., of Canton, Mass., said its bi-layered skin substitute, Apligraf, is included in the Outpatient Prospective Payment System, qualifying the treatment for reimbursement by Medicare when applied in a hospital outpatient setting. The OPPS list, a new program implemented by the Health Care Financing Administration, will take effect on Aug. 1.
¿ PE Biosystems, of Foster City, Calif., now called Applied Biosystems, said it entered into an agreement with the Ludwig Institute for Cancer Research to create an informatics infrastructure needed by high-throughput proteomics labs. Both parties will contribute software modules for incorporation into Applied Biosystems SQL*LIMS software.
¿ PPGx Inc., of Morrisville, N.C., said it launched its Gene Trials Bioinformatics Platform, a software and data integration package for the discovery of associations between drug effect and genetic variation.
¿ Roche Bioscience, of Basel, Switzerland, said it signed an agreement with Applied Biosystems, of Foster City, Calif., for the development and marketing of products that incorporate polymerase chain reaction technology, a process used for copying genetic materials.
¿ Tularik Inc., of San Francisco, said it initiated a Phase I/II efficacy study of its anticancer drug candidate T67 in patients with hepatocellular carcinoma. Study objectives include assessment of the drug's activity in multidrug-resistant tumors. Preclinical trials indicated T67 retains its activity against tumors resistant to other anticancer regimens.
¿ ValiGen N.V., of Paris and Newtown, Pa., said it acquired Berlin-based Infogen Medizinische Genetik GmbH, a company that provides risk assessment and disease management solutions using a large database of phenotypic profiles and genetic variants, mostly so far in the area of cardiovascular disease. Specific terms of the all-stock deal were not disclosed. ValiGen was formed this year through the merger of Kimeragen Inc. and Valigene SA. (See BioWorld Today, Feb. 14, 2000, p. 1.)
¿ Viragen Inc., of Plantation, Fla., said its Scottish subsidiary, along with the University of Nottingham and The Cancer Research Campaign charity in the UK, agreed to develop a new cancer vaccine technology for several cancer types. Researchers there discovered an antigen expressed more frequently on the surface of tumor cells. Initial work will focus on developing a peptide vaccine.
¿ ZymeTx Inc., of Oklahoma City, said it will use more than $300,000 in grant funding to advance existing viral diagnostics initiatives and for commercial development. ZymeTx is the recipient of a Phase I Small Business Innovation Research grant of $99,660 to develop therapeutic treatment for respiratory syncytial virus. It also received a three-year, $213,280 grant from the Oklahoma Center for the Advancement of Science and Technology.