¿ Aquila Biopharmaceuticals Inc., of Framingham, Mass., initiated a clinical trial to evaluate the efficacy of the Stimulon adjuvant QS-21 in improving current flu vaccines. The study is designed to measure the ability of QS-21 at improving the magnitude and pattern of immune responses produced by vaccines in healthy subjects aged 18 to 40.
¿ Arakis Ltd., of Cambridge, UK, entered a joint development agreement for AD 121, a novel chronotherapeutic version of an established rheumatoid arthritis therapeutic, with Penwest Pharmaceuticals Co. The companies will jointly develop the compound and share equally in commercialization profits. Chronotherapeutics are designed to release their active ingredients at a prespecified time intended to coincide with circadian sleep rhythms.
¿ Ariad Pharmaceuticals Inc., of Cambridge, Mass., said its Argent cell-growth switch-engineered muscle cells may be used for heart transplantation as a potential treatment for heart muscle damage due to myocardial infarction or cardiomyopathy. Treatment of engineered myoblasts incorporating the cell-growth switch using Argent's small-molecule Dimerizer drug resulted in selective proliferation without deleterious effects on other cardiac cells, according to a study presented at the American Heart Association meeting in New Orleans by Ariad collaborators from the University of Washington.
¿ Avax Technologies Inc., of Kansas City, Mo., said results of trials in which M-Vax, its autologous cell vaccine for melanoma, was administered to 37 stage IV melanoma patients who had undergone complete resection of metastatic tumors that had spread to various internal organs indicate a two-year survival rate of 60 percent. The estimated overall median survival time was 27 months or more, nearly double that of comparable historical data that showed a 15-month median survival rate with surgery alone. Those results were presented at the 18th Chemotherapy Foundation Symposium, "Innovative Cancer Therapy for Tomorrow."
¿ Biomira Inc., of Edmonton, Alberta, will continue its Phase III study of Theratope vaccine for metastatic breast cancer after a review of data from 600 patients in the pivotal trial by a Data Safety Monitoring Board produced a recommendation to continue. The review was the second by the board. Biomira is nearing full enrollment of 900 patients in the trial, which is under way in 120 sites in North America, Europe, Australia and New Zealand, and expects to complete enrollment by year's end.
¿ BioSpecifics Technologies Corp., of Lynbrook, N.Y., said the FDA's Office of Orphan Drug Product Development approved a grant funding a Phase III trial of Cordase, the company's injectable collagenase for Dupuytren's disease. Formal permission to begin the Phase III trial is contingent on FDA review of Phase II trial results. The company anticipates a Phase III trial will begin in 2001.
¿ Cellegy Pharmaceuticals Inc., of South San Francisco, filed for marketing approval of Rectogesic (nitroglycerin ointment) with New Zealand's Ministry of Health. The treatment for anal fissures was approved by the Australian Therapeutic Goods Administration last year and is, the company said, among the leaders in Australia in the anal fissure and hemorrhoid market.
¿ Endovasc Ltd. Inc., of Montgomery, Texas, received the second $1.5 million installment of a three-part $4.5 million convertible preferred stock placement. The funding is aimed at advancing the company's clinical program for Liprostin, its liposome-encapsulated form of prostaglandin E-1. Phase I/II trials of Liprostin have begun evaluating the compound's ability to improve circulation in the lower limbs of patients with critical limb ischemia.
¿ Geron Corp., of Menlo Park, Calif., said research demonstrated that the telomerase gene restores aging skin cells' ability to form normal skin structures in a mouse model of tissue formation. Introduction of telomerase to aging fibroblasts increased their divisive capability and restored their ability to reconstitute normal human skin structures in the mouse model.
¿ Hemosol Inc., of Toronto, said it signed a C$35 million (US$22.7 million) senior credit facility with the National Bank of Canada and The Bank of Nova Scotia to finance a portion of construction and land costs associated with its C$65 million Hemolink manufacturing facility in Missassauga, Ontario. The company also is expected to complete a C$12.5 million credit facility with a subordinated lender shortly, completing, with current cash resources, the remaining balance of land and construction costs. Construction on the 120,000-square-foot facility has begun.
¿ Hybridon Inc., of Cambridge, Mass., presented safety data from two ongoing Phase I trials of its second-generation antisense compound, GEM 231 - a mixed-backbone oligonucleotide for treatment of solid tumors, in combination with Taxotere or Taxol - at the 11th Annual NCI-EORTC-AACR Symposium on New Drugs in Cancer Therapy in Amsterdam. Data indicate that side effects associated with the compound were mild and reversible and that the compound did not increase the side effects produced by the taxanes.
¿ ICOS Corp., of Bothell, Wash., entered an exclusive license agreement with Stanford University for polyphosphate kinase (PPK) technology. Financial details were undisclosed. The company plans to explore inhibitors of PPK as broad-spectrum antibiotics, and is identifying drug candidates.
¿ National Institutes of Health researchers have found a variation in an immune system gene called RANTES that substantially increases susceptibility to HIV but subsequently slows the disease's progress. A single nucleotide polymorphism that appears significantly more often in HIV-positive individuals than in HIV-resistant individuals is associated with up to twice the risk of HIV infection, but individuals with the SNP infected with HIV take about 40 percent longer to develop AIDS.
¿ Onyx Pharmaceuticals Inc., of Richmond, Calif., presented clinical and preclinical data on several of its anticancer compounds at the 11th Annual NCI-EORTC-AACR Symposium on New Drugs in Cancer Therapy in Amsterdam. Two clinical studies on CI-1042 showed the therapeutic virus selectively replicates in and kills cancer cells with abnormal p53 function, and that the compound in combination with total body radiation produces higher antitumor activity than each treatment strategy alone. The company also presented results of studies of its Raf kinase inhibitor, its therapeutic vaccines targeting RB-deficient tumors and a selectively replicating adenovirus, a modified version of CI-1042.
¿ Oncolytics Biotech Inc., of Calgary, Alberta, demonstrated in an athymic mouse model that treatment with Reolysin, the company's treatment for malignant gliomas, resulted in dramatic extension of life. Animals treated with Reolysin were alive at termination of the study, 90 days later, in 82 percent of cases. Nontreated animals exhibited a median survival of 48 days.
¿ Sonus Pharmaceuticals Inc., of Bothell, Wash., said researchers at the State University of New York at Buffalo have shown blood substitute product S-9156, a perfluorocarbon-based emulsion, to be an efficient oxygen-delivery vehicle at a lower dosage than other fluorocarbon-based compounds in development. The preclinical study showed that a small dose of S-9156 transported a sufficient amount of oxygen to sustain life in rats with 90 percent of red blood cells removed.
¿ SuperGen Inc., of San Ramon, Calif., said data from two separate studies indicated its anticancer compound pentostatin, known as Nipent, in combination therapy is extremely active in several refractory blood cancers. SuperGen said pentostatin in combination with Rituximab produces response rates of nearly 100 percent. A separate study of pentostatin and cyclophosphamide in previously treated patients with chronic lymphocytic leukemia produced a response rate of 71 percent in 14 evaluable patients and a response rate of 22 percent in the total population of 21 patients enrolled.
¿ Transgene SA, of Strasbourg, France, appointed Gilles Belanger CEO. Belanger was the vice president in charge of international development for Silliker bioMerieux, also a subsidiary of Transgene's parent company, bioMerieux, of Strasbourg. Transgene also approved a plan to raise at least $51.4 million through a public offering. The size of the offering has not been determined, and the offering itself is subject to approval by the company's shareholders at an extraordinary meeting scheduled for the beginning of 2001.
¿ Union Biometrica Inc., of Somerville, Mass., named David Deems CEO. The company, designers of customized research systems for drug discovery founded by Peter Hansen and Petra Krauledat, said Deems, the former vice president of BD Biosciences Inc., of San Jose, Calif., a division of Becton, Dickinson and Co., will oversee advancement of the company's technology products for automated screening of functional and disease model organisms and cells.