¿ Achillion Pharmaceuticals Inc., of New Haven, Conn., initiated a Phase I trial of its lead antiviral drug, ACH-126,443, in Scotland. The drug is an orally administered antiviral agent with activity against the hepatitis B virus and HIV.
¿ Advanced Viral Research Corp., of Yonkers, N.Y., agreed to research the immunological effects of its immunomodulator and antiviral drug, Product R, with the Weizmann Institute of Science, of Rehovot, Israel, and its developmental arm, YEDA, also located in Rehovot. Scientists from Weizmann will investigate the effects of Product R on immune function, especially on T lymphocytes.
¿ Antigenics Inc., of New York, said the FDA approved its plans to begin clinical testing for its immunotherapuetic AG-701 in patients diagnosed with herpes simplex virus type 2. The company filed an investigational new drug application for the research in December. The product is the first infectious disease to be evaluated in the clinic using the company's proprietary heat shock protein technology.
¿ Avax Technologies Inc., of Kansas City, Mo., said its French subsidiary received a contract with the French Army to prepare a clinical trial of the company's thymidine kinase suicide gene program for prevention of graft-vs.-host disease following allogenic bone marrow transplantation. The research is geared toward evaluating the potential of using Avax' thymidine kinase gene approach in allowing the use of allogenic bone marrow for treatment of severe irradiation. The contract is valued at $140,000.
¿ Biomira Inc., of Edmonton, Alberta, said it has recruited 903 patients to date in its Phase III trial of Theratope vaccine for metastatic breast cancer. The protocol called for 900 patients. The study will remain open until March to ensure a sufficient number of evaluable patients. The 120-site worldwide trial is designed to determine whether Theratope vaccine can delay the disease's progression and increase survival rates.
¿ Cambridge Neuroscience plc, of Norwood, Mass., following the December merger with CeNeS Pharmaceuticals plc, of Cambridge, UK, has been renamed CeNeS Pharmaceuticals Inc.
¿ CollaGenex Pharmaceuticals Inc., of Newtown, Pa., said the FDA granted marketing approval for a new tablet formulation of Periostat, indicated for the adjunctive treatment of adult periodontitis. Periostat is the first orally administered, systemically delivered drug targeted for use in conjunction with treatments for adult periodontitis.
¿ Cytoclonal Pharmaceutics Inc., of Dallas, created a library of inhibitor DNA sequences against all of the 3,918 known genes of Mycobacterium tuberculosis, the bacteria that causes tuberculosis.
¿ HTS Biosystems Inc., of Hopkinton, Mass., entered a license, purchase and distribution agreement with Mitsubishi Chemical Corp., of Tokyo. Mitsubishi earlier purchased an option to the exclusive right to distribute HTS's bioanalysis system in Japan. Mitsubishi also obtained an exclusive license to HTS's surface plasmon resonance technology, the core array technology for HTS's bioanalysis systems, in addition to purchasing research systems and chips. Further financial terms were undisclosed.
¿ Imgenex Corp., of San Diego, and Genzyme Molecular Oncology, a division of Genzyme General, of Cambridge, Mass., formed an alliance aimed at reagent development useful in the study of angiogenesis. The companies discovered and began characterizing proteins associated specifically with tumor blood vessels utilizing Genzyme's SAGE (serial analysis of gene expression) technology. Genzyme agreed to provide details of the proteins to Imgenex, which will develop monoclonal antibodies that recognize and potentially will interfere with the function of the proteins. Imgenex will retain rights to commercialize the reagents and will pay royalties to Genzyme on those sales.
¿ Incara Pharmaceuticals Inc., of Research Triangle Park, N.C., selected a catalytic antioxidant, AEOL 10150, for late-stage preclinical development to support an investigational new drug application for treatment of ischemic stroke. Incara intends to file the IND by the end of the year. The company said the compound has shown activity in animal models comparable or superior to compounds currently in development for temporary and permanent blockage of a brain-supplying artery.
¿ NeoTherapeutics Inc., of Irvine, Calif., plans to initiate a 12-week, pivotal, higher-dose study of Neotrofin in Alzheimer's disease to evaluate the drug candidate's effectiveness at higher dose levels, which were well tolerated in previous studies. The study, scheduled to begin in April, is slated to conclude by the end of the year, and a second, longer-term pivotal study designed to measure disease course modification over a 12-month term and effects on symptom improvement at 12 weeks is scheduled to begin in the second half of this year.
¿ Oxford Biomedica plc, of Oxford, UK, entered an agreement with King's College in London, giving Oxford exclusive rights to RAR beta-2, a proprietary gene associated with nerve regeneration. The company said the combination of the gene and its LentiVector gene delivery system could lead to a product for nerve repair in neuropathies associated with diseases such as diabetes and vascular disorders.
¿ Pharmagenesis Inc., of Palo Alto, Calif., promoted Nicolas Druz to chairman and CEO and Francois Guinot was named president. The company develops ethical pharmaceuticals from purified extracts of plants that have been employed in traditional Chinese medicine for more than 4,000 years. It focuses on developing anticancer therapies, treatments for cancer therapy-related bone marrow suppression and for the management of transplant rejection.
¿ Physiome Sciences Inc., of Princeton, N.J., said it entered an agreement to provide cardiac stimulation software to Janssen Pharmaceutica N.V., a subsidiary of Johnson & Johnson, of New Brunswick, N.J. The multiyear licensing and development agreement grants J&J rights to test candidate drugs on computers using Physiome's CardioPrism software and physiological information databases. Financial terms were undisclosed.
¿ Pyroseqeuncing AB, of Uppsala, Sweden, said it signed its first high-throughput sequencing customer. The Preferred Technology Program, based on the company's Pyroseqeuncing technology, was purchased by the Wallenberg Consortium North, the new Swedish consortium for functional genomics.
¿ Replicor Inc., of Montreal, said it completed a private placement grossing the company C$2.6 million (US$1.73 million). The company said it will use the funding to accelerate its research programs in gene therapy and cancer.
¿ Schering-Plough Corp., of Kenilworth, N.J., and Centocor Inc., of Malvern, Pa., said the European Union's Commission of European Communities granted marketing authorization for Remicade with methotrexate for improvement of physical function of patients with rheumatoid arthritis and for the reduction of the rate of progression of joint damage when response to disease-modifying drugs, including methotrexate, has been inadequate. The approval follows a positive recommendation by the Committee for Proprietary Medicinal Products in October. The companies received a similar recommendation from the FDA's Arthritis Advisory Committee in July. (See BioWorld Today, July 17, 2000.)
¿ SciClone Pharmaceuticals Inc., of San Mateo, Calif., said Zadaxin, its thymosin alpha 1 synthetic peptide for treatment of hepatitis B, was approved for marketing in India, and the company could begin commercial introduction of the therapy in India in the second quarter. The company said estimates place the number of hepatitis B-infected Indians at 45 million. Zadaxin is in Phase III testing in the U.S. in combination with Pegasys (pegylated interferon alfa-2a) for treatment of hepatitis C, Phase II testing in combination with lamivudine for treatment of hepatitis B, and Phase II testing for treatment of liver cancer. SciClone also is testing the drug in Japan and in Australia, and in Europe in a pivotal Phase III program for treatment of hepatitis C.
¿ Serono S.A., of Geneva, Switzerland, launched two enhancements to its fertility portfolio in the U.S., Ovidrel and Cetrotide. Ovidrel (choriogonadotropin alfa for injection) is designed for use after ovarian stimulation with follicle stimulating hormone to help follicles mature in women undergoing assisted reproductive technology treatment such as in vitro fertilization and to trigger ovulation in infertile women with ovarian dysfunction. Cetrotide (cetrorelix acetate for injection), a gonadotropin releasing hormone antagonist, is designed to prevent premature ovulation in women undergoing controlled ovarian stimulation. In separate news, Serono said the European Commission approved the highest available dose of Rebif, the company's multiple sclerosis drug, and recommended it as first-line therapy for treatment of relapsing-remitting MS.
¿ United Therapeutics Corp., of Silver Spring, Md., said it submitted a marketing authorization application in France for approval of the prostacyclin analogue UT-15 for treatment of pulmonary arterial hypertension. UT submitted a new drug application for the compound to the FDA in October.
¿ Zarix Inc., of Berwyn, Pa., initiated trials in Canada for Thymitaq as part of its pivotal Phase III trials for the drug. Thymitaq is a thymidylate synthase inhibitor and is being developed to treat several different cancers with an initial emphasis in hepatocellular carcinoma. It is being tested at sites in the United States, Europe and South Africa ,and patients for the Canadian sites will begin enrollment this month, the company said.
¿ Zyomyx Inc., of Hayward, Calif., appointed Lawrence Cohen chief executive officer and Garrett Roper as senior vice president, chief financial officer. Cohen is the company's former chief operating officer, and replaces Yasunori Kaneko, who served as CEO since October.