¿ AnorMED Inc., of Vancouver, British Columbia, said it will discontinue its Phase Ia/IIb trial of AMD-3100 in HIV due in part to abnormal cardiac activity, referred to as premature ventricular beats, observed in two patients who received different doses of AMD-3100 within the higher-dose cohorts. Also, AMD-3100 did not meet the criteria for efficacy in the trial at the doses evaluated. AnorMED will continue to work with other candidates in its chemokine inhibitor program.
¿ Atlantic Technology Ventures Inc., of New York, entered a research collaboration with Christopher Vaughan, senior scientist at the Pain Management and Research Center, Royal North Shore Hospital of the University of Sydney in Sydney, Australia. They will work to investigate the synergistic effects of opioids and cannabinoids, specifically Atlantic¿s CT-3, a synthetic derivative of tetrahydrocannabinol.
¿ Azign Bioscience AS, a wholly owned subsidiary of NeuroSearch AS, of Ballerup, Denmark, sold a license to its patent rights for use within the reagent market to Qbiogene Inc., of Montreal. The transaction includes the sale of stock, customer files and customer service systems for this market. Financial details were not disclosed.
¿ Blue Heron Biotechnology Inc., of Bothell, Wash., launched GeneMaker 1.0, its gene synthesis platform. Gene-Maker is a scalable, automated, high-throughput manufacturing platform that can synthesize genes, gene variants or DNA sequences, the company said.
¿ British Biotech plc, of Oxford, UK, and ImmunoGen Inc., of Cambridge, Mass., started patient enrollment for a Phase I/II study to evaluate the Tumor-Activated Prodrug (TAP) BB-10901/huN901-DM1 in small-cell lung cancer patients. Patient will receive a once-weekly intravenous dose of BB-10901 for four weeks, followed by two weeks off, which defines one cycle of treatment. Patients may be eligible to receive repeat cycles. About 80 patients who have failed other treatment options are expected to participate in this study. British Biotech¿s stock (NASDAQ:BBIOY) moved up 35 cents Tuesday, or about 13 percent, to close at $3.10.
¿ Cytomyx Ltd., of Cambridge, UK, raised #2 million (US$2.8 million) in connection with an application for admission to trade on the Alternative Investment Market of the London Stock Exchange. Cytomyx¿s shares began trading on the AIM Tuesday under the symbol CYX.
¿ Demegen Inc., of Pittsburgh, submitted pre-investigational new drug application documentation and a clinical plan for its treatment, Demegel, to the FDA. Demegel has demonstrated in vitro activity against multidrug-resistant organisms and has treated infections in standard burn and wound animal studies. Demegen anticipates filing an IND for Demegel this year.
¿ The Department of Oral Biology, a joint department of the Harvard School of Dental Medicine and The Forsyth Institute, discovered a genetic mutation responsible for a childhood bone disorder called cherubism. The disorder causes children to develop chubby cheeks and upward-looking eyes. The discovery was reported in the June 1, 2001, issue of Nature Genetics.
¿ Gene Logic Inc., of Gaithersburg, Md., said it will launch an enterprise gene expression software product at the BIO 2001 International Conference in San Diego, June 24-27. The software system is based on Gene Logic¿s existing data management platform that supports its product, GeneExpress Suite. The platform will allow researchers to integrate, manage and analyze internally generated gene expression data, in the context of comprehensive gene annotations with external proprietary and publicly available data sources such as GenBank, SwissProt, LocusLink and UniGene, the company said.
¿ HTS Biosystems Inc., of Hopkinton, Mass., hired Masaaki Sasajima to establish its Asian operations, to be headquartered in Yokohama, Japan. Sasajima will support HTS¿s expansion into the Asian proteomics market and will manage its relationship with Mitsubishi Chemical Corp., of Tokyo.
¿ Genzyme Corp., of Cambridge, Mass., said it intends to construct a 300,000-square-foot recombinant protein manufacturing facility in Framingham, Mass. Construction is scheduled to begin in the fall, with operations anticipated in 2004. Also, it will establish a manufacturing facility in Ireland for the production of Renagel. Genzyme purchased an existing 120,000-square-foot facility located in Waterford, Ireland. Genzyme expects the facility to be fully operational and approved by regulatory authorities by mid-2003. As a follow-on to that facility, Genzyme is planning a multiproduct manufacturing center in Waterford. Genzyme is expanding its Haverhill manufacturing operations in the United Kingdom to meet manufacturing demand for Renagel as well.
¿ Genzyme General, of Cambridge, Mass., reported data from its Phase III extension study of Fabrazyme, demonstrating the product¿s ability to clear the lipid globotriaosylceramide (GL-3) from a range of cell types in organs affected by Fabry disease. These findings augment previously announced results from the pivotal trial of Fabrazyme and the extension study showing Fabrazyme clears GL-3 from endothelial cells in the heart, kidney and skin. A biologics license application for Fabrazyme is under review by the FDA. (See BioWorld Today, Dec. 28, 2000, and Oct. 6, 2000.)
¿ KS Biomedix Holdings plc, of Guilford, UK, signed an agreement with MedPharm Ltd., of London, to develop a solid-dosage form of a therapeutic antibody to treat ulcerative colitits being developed by KS Biomedix. KS Biomedix has two antibodies in development for ulcerative colitis. Initially, MedPharm will work on a solid-dosage form for the most advanced candidate. Financial details were not disclosed.
¿ Medarex Inc., of Princeton, N.J., adopted a shareholders rights plan designed to ensure that Medarex shareholders will receive fair and equal treatment in the event of any unsolicited offer or takeover attempt to acquire Medarex. The plan was not adopted in response to any specific effort to acquire Medarex, the company said.
¿ Martek Biosciences Corp., of Columbia, Md., and the Torrey Mesa Research Institute, of La Jolla, Calif., a wholly owned subsidiary of Syngenta, of Basel, Switzerland, initiated a joint research and development project to find and characterize genes from microalgae, focusing primarily on the docosahexaenoic acid (DHA) pathway. The companies have cross-royalty arrangements and Martek has exclusive, worldwide commercialization rights to use the genes in microbial production of docosahexaenoic acid. The Torrey Institute has rights to use the genes in agricultural crop species. Financial details were not disclosed.
¿ Oxxon Pharmaccines Ltd., of Oxford, UK, commenced Phase I trials of its melanoma pharmaccine. The trial will evaluate the safety and immunogenicity of the melanoma pharmaccine in early stage melanoma patients with low tumor burden. Oxxon¿s treatment involves priming with a DNA vaccine and then a boost inoculation with the recombinant viral vector, modified vaccinia virus Ankara.
¿ Pharmasset Inc., of Atlanta, received a Phase I Small Business Innovation Research grant from the National Institutes of Health, of Bethesda, Md. The grant of $250,000 will fund research on the development of novel benzamide riboside analogues as anticancer agents. The overall aim will be to develop a new agent for the treatment of human colon carcinoma.
¿ Pharmos Corp., of Rehovot, Israel, said it was awarded a grant of up to $1.7 million by the Office of the Chief Scientist of Israel¿s Ministry of Industry and Trade to help fund Pharmos¿ development of dexanabinol for traumatic brain injury. The grant is available through fiscal year 2001.
¿ PPL Therapeutics plc, of Edinburgh, Scotland, and Bayer Corp., of Research Triangle Park, N.C., said they received a positive opinion from the Committee for Orphan Medicinal Products on recombinant human alpha 1-antitrypsin in the indication of treatment of emphysema secondary to congenital alpha 1-antitrypsin deficiency. This is the first step in obtaining an orphan medicinal drug designation from the European Commission for the product, the companies said.
¿ Telik Inc., of South San Francisco, initiated a Phase II trial of TLK286 in refractory ovarian cancer patients. The company currently has a Phase II trial evaluating TLK286 in refractory colon cancer. TLK286 is a small-molecule candidate that targets tumors that overexpress GST P1-1.
¿ The Immune Response Corp., of Carlsbad, Calif., said data were published from a 15-patient, open-label research study suggesting treatment with Remune may increase the frequency of CD8+ T cells. CD8+ T cells are capable of killing virus-infected cells through molecules, called perforin, in chronically HIV-infected patients treated concurrently with antiviral drug therapy. The study appears in the May 2001 issue of the Journal of Clinical and Experimental Immunology.
¿ VaxGen Inc., of Brisbane, Calif., presented laboratory data at the Cold Spring Harbor 2001 Meeting on Retroviruses last week that indicated its HIV/AIDS vaccine induces immune responses capable of preventing infection from a broader array of HIV strains than previously detected. The findings suggest the vaccine, AIDSVax, may be effective against HIV strains found in nature, also known as primary isolates. VaxGen¿s stock (NASDAQ:VXGN) rose $5 Tuesday, or about 26.5 percent, to close at $23.89. It raised $20 million privately last week to fund the launch of AIDSVax, currently in Phase III trials. (See BioWorld Today, May 25, 2001.)