¿ AVI BioPharma Inc., of Portland, Ore., presented research results demonstrating a liver enzyme involved in drug metabolism can be modulated to impact the effectiveness of drugs, at the 40th annual Society of Toxicology Meeting in San Francisco. Research results, which centered on cytochrome P450 expression regulation, showed that a proprietary Neugene antisense compound could slow the body's drug breakdown machinery, allowing for smaller doses, reduced toxicity and heightened effectiveness of drugs.
¿ Coley Pharmaceutical Group, of Wellesley, Mass., commenced operations at its research facility in Langenfeld, Germany. The laboratory will provide space for its immunology, molecular biology and biochemistry departments, as well as European clinical, regulatory and administrative functions. It also will house its Human Cell Screening drug discovery platform.
¿ Compugen Ltd., of Tel Aviv, Israel, appointed Vincent Zurawski CEO of its U.S. subsidiary, Compugen Inc. Zurawski was co-founder of Centocor Inc., of Malvern, Pa., and CEO and president of Apollon Inc., also of Malvern, a Centocor spin-off.
¿ Curis Inc., of Cambridge, Mass., initiated a Phase I trial of Vascugel, a cellular transplant product, in patients undergoing coronary artery bypass graft (CABG) surgery. Vascugel is being developed to prevent complications related to cardiovascular surgical procedures and maintain long-lasting blood flow and tissue perfusion. It is a biodegradable implant containing human endothelial cells that will be wrapped at the junction of the bypassed and grafted coronary blood vessels at the time of the CABG procedures in the trial.
¿ DNAPrint genomics Inc., of Sarasota, Fla., said it completed its move to its new location in Sarasota.
¿ Elan Corp. plc, of Dublin, Ireland, said it completed all steps needed to launch Myocet in Europe in combination with cyclophosphamide for first-line treatment of metastatic breast cancer. Holders of its contingent value rights (CVR) will receive an initial cash payment of $51.9 million, representing the $54 million mapped out under the CVR agreement, minus $2.1 million incurred by Elan and its subsidiaries in connection with achieving the necessary milestones. Elan expects to introduce Myocet in Europe in the second quarter of this year. Elan acquired Myocet, formerly Evacet, through its acquisition of The Liposome Co. Inc., of Princeton, N.J., in a deal that included stipulations for Liposome shareholders to receive payments due at Myocet's European approval and then due again if net sales of the drug in certain EU countries and Canada reach set levels. (See BioWorld Today, March 7, 2000.)
¿ Enzon Inc., of Piscataway, N.J., said Schering-Plough Corp., of Madison, N.J., were granted centralized marketing authorization for Peg-Intron Injection and Rebetol Capsules as combination therapy for relapsed and naove adult patients with proven chronic hepatitis C by the European Commission of the European Union. Peg-Intron is a longer-acting form of Schering's Intron A that uses PEG technology developed by Enzon. Enzon is entitled to royalties on sales.
¿ Gene Logic Inc., of Gaithersburg, Md., and Lark Technologies Inc., of Houston, entered an agreement for Lark to provide genomic services to support Gene Logic's GeneExpress Suite of databases. Lark will be responsible for supporting the CloneExpress Library, a clone data module that will be a component of the GeneExpress Suite. Financial terms were not disclosed.
¿ Genelabs Technologies Inc., of Redwood City, Calif., said positive results from lead compounds generated by its DNA-targeted drug discovery research program were presented at the 5th International Antifungal Drug Discovery & Development Summit in Princeton, N.J. Data from two representative antifungal agents demonstrated that Genelab's DNA-binding compounds appear to be broad-spectrum fungicidal agents that show low levels of toxicity to a human cell line and were well tolerated in mice.
¿ Genencor International Inc., of Palo Alto, Calif., assembled experts in the E. coli research field to form the EcoReg Consortium, with the mission to construct and maintain a database that will warehouse information on the genetic regulation of E. coli. The database initially will be funded by Genencor and will be available online for free.
¿ Genometrix Inc., of The Woodlands, Texas, was selected by Agouron Pharmaceuticals Inc., of La Jolla, Calif., to identify, characterize and validate single nucleotide polymorphisms. SNPs from the discovery effort and the public domain can be screened against Genometrix's population diversity panel to determine the distribution of these alleles in a representative, ethnically diverse population.
¿ Genzyme General, of Cambridge, Mass., said the Committee for Proprietary Medicinal Products issued a positive opinion on the marketing authorization application for Fabrazyme (agalsidase beta) enzyme replacement therapy for Fabry disease. The decision has been forwarded to the European Commission, which should make a final decision on marketing approval in three to four months. If marketing authorization is granted, Genzyme General plans to launch Fabrazyme in Europe on a country-by-country basis, pending pricing and reimbursement approvals. (See BioWorld Today, Dec. 28, 2000, and Jan. 5, 2001.)
¿ Hemosol Inc., of Toronto, said its underwriters, UBS Warburg LLC, of Stamford, Conn., and Dain Rauscher Wessels, of Minneapolis, exercised in full their overallotment option. Hemosol raised additional net proceeds of about $9 million through the sale of 1.05 million shares at $8.78 apiece. It priced its public offering early this month and raised about $56 million before overallotments. (See BioWorld Today, March 2, 2001.)
¿ La Jolla Pharmaceutical Co., of San Diego, presented three papers on results of its Phase II/III trial of its lead product for lupus, LJP 394, at the 6th International Lupus Conference in Barcelona, Spain. The results showed that as the dose of LJP 394 increased, the number of renal flares decreased in drug-treated patients relative to placebo patients. The results were seen in the 89 percent of patients with high-affinity antibodies to LJP 394. There is a Phase III trial under way.
¿ MediGene AG, of Martinsried, Germany, and Evotec Biosystems AG, of Hamburg, Germany, said MediGene will collaborate with Evotec OAI, a supplier of biological, chemical and screening services, to identify drugs for cardiac diseases. Evotec will search for therapeutic molecules relating to a target identified by MediGene. MediGene will keep rights to targets and will receive rights to the identified therapeutic substances. Evotec OAI will receive a fixed payment for agreed services, milestone payments and royalties. Further financial details were not disclosed.
¿ National Institutes of Health, of Bethesda, Md., and the National Institute of Allergy and Infectious Diseases, said an animal study appearing in the April edition of Nature Immunology identifies eosinophils as key players in food-induced inflammation of the digestive tract. Eosinophils often appear in high numbers at sites of allergic inflammation, but researchers have not known if the cells cause the disease or merely are present.
¿ NeoPharm Inc., of Lake Forest, Ill., filed an investigational new drug application for Liposome Encapsulated Mitoxantrone, its sixth cancer compound to enter clinical testing in the past three years, for the treatment of prostate cancer and multiple sclerosis. It said it should receive FDA clearance to initiate Phase I/II trials later this year.
¿ Texas Heart Institute, of Houston; St. Luke's Episcopal Hospital, of Houston; and The University of Texas Medical School at Houston said researchers are developing a type of gene therapy that could revolutionize treating patients with atherosclerosis. Doctors expect to begin clinical trials this year in patients who have undergone angioplasty or other catheter-based interventions to remove plaque and restore blood flow in their arteries. They will examine whether gene transfer of tissue factor pathway inhibitor (TFPI) reduces patients' risk of redeveloping buildup and blood clots in vessels damaged during the medical procedure. Successful use of the therapy was reported in the March 27, 2001, issue of the Proceedings of the National Academy of Sciences.
¿ Titan Pharmaceuticals Inc., of San Francisco, initiated a Phase I/II study of Pivanex, a small-molecule drug that attacks cancer cells by cellular differentiation, for the treatment of liver tumors. The study will enroll 25 patients and is designed to assess Pivanex in patients with either metastatic or primary hepatic tumors with endpoints of safety, tumor response and survival.
¿ Transgene SA, of Strasbourg, France, said it is focusing on what it believes is its most promising product candidates in the cancer immunotherapy area. The company is discontinuing development of a product candidate using an earlier generation vaccinia virus vector and instead plans to use a new formulation of a Muc1 vaccine product using a new vector based on the modified virus ankara strain. Phase II trials of the MVA-Muc1-IL2 product candidate should begin in the fourth quarter. It has several other therapies in development.
¿ Transkaryotic Therapies Inc., of Cambridge, Mass., said the Committee for Proprietary Medicinal Products of the European Agency for the Evaluation of Medicinal Products issued a positive opinion recommending approval of Replagal (agalsidase alfa) enzyme replacement therapy for Fabry disease. The recommendation will be forwarded to the European Commission for marketing authorization and if approved, TKT Europe-5S AB will have a license for marketing Replagal throughout the European Union. A decision is expected in a few months. TKT Europe-5S would launch and market Replagal in Europe upon approval. (See BioWorld Today, Dec. 28, 2000, and Jan. 5, 2001.)