¿ Accelrys, a wholly owned subsidiary of Pharmacopeia Inc., of Princeton, N.J., and GlaxoSmithKline plc, of London, said they collaborated to produce software that enables GSK scientists to access, analyze and visualize chemical and biological data stored on its R&D databases. The prototype solution was based on Accelrys¿ Accord Grid Control, a tool for displaying structures, reactions and other data in a grid format. Terms were not disclosed.
¿ Active Biotech AB, of Lund, Sweden, said a Phase II study of its multiple sclerosis drug SAIK-MS is expected to start in the first quarter of 2002 in three countries in Europe and will last 18 months. The company said the oral product has a new mode of action, though it didn¿t say what that was.
¿ Genentech Inc., of South San Francisco, said the National Cancer Institute stopped recruitment in a Phase II trial of Genentech¿s angiogenesis inhibitor, Avastin (bevacizumab) ¿ a humanized antibody to VEGF ¿ in metastatic renal cell carcinoma. A monitoring board determined the trial had reached its prespecified efficacy endpoint at the second interim analysis. An independent review is planned to further analyze the data and determine the significance before the next steps are taken. The company previously reported encouraging Phase II results in colorectal and breast cancers. Separately, Genentech said a Los Angeles County Superior Court jury was unable to reach a verdict, and thus unable to find liability for Genentech, in a contract dispute lawsuit brought by the City of Hope related to a 1976 agreement covering sponsored research. City of Hope wanted hundreds of millions of dollars in royalties in addition to the $293 million already paid, Genentech said. Jurors voted 7-5 in Genentech¿s favor on whether the company breached the agreement, Genentech said.
¿ U.S. Environmental Protection Agency officials approved the reregistration for corn containing a protein from Bacillus thuringiensis for an additional seven years. The agency said scientific evidence shows BT corn does not impact monarch butterflies or other wildlife, and has not shown adverse effects on humans.
¿ Isis Pharmaceuticals Inc., of Carlsbad, Calif., completed a follow-on offering of 5 million shares at $20 each, raising $100 million. When the offering was proposed the company was to sell 5 million shares and its stock opened at $18.30, which would have resulted in proceeds of $91.5 million. UBS Warburg LLC is lead underwriter. Co-underwriters are Robertson Stephens Inc., Needham & Co. Inc. and Fortis Securities Inc. (See BioWorld Today, Oct. 10, 2001.)
¿ AVAX Technologies Inc., of Kansas City, Mo., said it met with the FDA regarding the clinical hold on its M-Vax and O-Vax autologous cancer vaccines. It was recommended that AVAX prepare and submit new investigational new drug applications for the frozen vaccine. Before that, work related to characterization of the new product needs to be completed, work AVAX said already was in progress. The company said it is evaluating its best plan of action for developing the technology. (See BioWorld Today, Sept. 24, 2001, and April 24, 2001.)
¿ Aclara BioSciences Inc., of Mountain View, Calif., and Third Wave Technologies Inc., of Madison, Wis., will collaborate on the development and commercialization of multiplexed gene expression research products that couple the high-multiplexing capabilities of Aclara¿s eTag sequence-labeling technology with Third Wave¿s Invader platform. The combination will enable customers to profile many genes simultaneously in a single reaction directly from crude cell lysates, without the need for sample prep or polymerase chain reaction.
¿ AnorMED Inc., of Vancouver, British Columbia, presented updated Phase II ovarian cancer data for ZD0473, a new-generation platinum anticancer agent, at the European Conference of Clinical Oncology in Lisbon, Portugal. The data from the ongoing study showed a response rate of 39 percent in second-line platinum-sensitive ovarian cancer patients and a 7 percent response rate in second-line platinum-resistant patients. In light of this data, AstraZeneca plc, of London, is evaluating the Phase III development program options of ZD0473 in ovarian cancer and other tumors. These data support the conclusion that ZD0473 is an active drug with a manageable toxicity profile.
¿ Applied Biosystems Group, of Foster City, Calif., an Applera Corp. business, introduced its Assays-by-Design service, which is expected to provide customized and quality-validated assays for single nucleotide polymorphism genotyping and gene expression studies. The Assays-by-Design service is the first phase of an Applera-wide discovery program.
¿ Cellegy Pharmaceuticals Inc., of South San Francisco, said Jennifer Berman, women¿s health researcher at the University of California, Los Angeles, Medical Center, will present this weekend at the Female Sexual Function Forum in Boston. Berman will report results of a study investigating the effect of nitroglycerin in the reduction of genital pain in women with vulvadynia. This open-label study involved 12 patients, all of whom had reproducible pain during an office visit that was relieved within five minutes by application of nitroglycerin ointment. Six subjects who participated in the three-month study had a significant reduction of pain during sexual activity. Although well tolerated, headache occurred in the majority of women.
¿ Chroma Therapeutics Ltd., of Oxford, UK, received seed financing of #1.5 million (US$2.15 million) from Abingworth Management Ltd., of London, and Cancer Research Ventures Ltd., of London. Chroma initially will focus on identifying novel anticancer drugs based on the growing number of enzymes involved in the remodeling of chromatin.
¿ Collateral Therapeutics Inc., of San Diego, and its development partner, Schering AG, of Berlin, reported that the Medicines Control Agency in the UK authorized the initiation of a large-scale Phase IIb/III trial in the UK as part of the European clinical development for Generx, Collateral¿s lead product candidate for the treatment of stable exertional angina due to coronary artery disease. Patient enrollment for the European trial is expected to begin in January. In addition, the company reported that the U.S. portion of the Generx development program is under way and patients are being enrolled at an initial 12 U.S. medical centers. (See BioWorld Today, June 19, 2001.)
¿ DoubleTwist Inc., of Oakland, Calif., launched its online service for genomic research. The GenomeZone service at DoubleTwist.com will provide subscribers access to the entire DoubleTwist Annotated Human Genome Database, which features more than 35 integrated public and proprietary databases including DoubleTwist¿s annotated human and mouse gene indices.
¿ Durect Corp., of Cupertino, Calif., reported research results showing in animal models that new blood vessels are formed and that blood flow to an ischemic heart can be restored following targeted delivery of fibroblast growth factor to the heart. These results are from an ongoing research collaboration initiated in 1998 between Durect and the department of pharmacology and toxicology at the Cardiovascular Research Institute Maastricht, University of Maastricht, the Netherlands, focusing on targeted chronic administration of compounds to the diseased heart.
¿ Exten Industries Inc., of San Diego, established a new corporate office for Exten and its Xenogenics Corp. subsidiary. ¿The acquisition of MultiCell coupled with the anticipated expansion of our company required room to grow, which was not feasible in our former location,¿ Exten President Greg Szabo said.
¿ Genaera Corp., of Plymouth Meeting, Pa., presented two preclinical studies on its mucoregulator therapy, Lomucin, at the North American Cystic Fibrosis Conference being held in Orlando, Fla. The mucoregulator program is Genaera¿s second product development program based on its genomics discoveries. The studies highlight the mechanism of a novel calcium-activated chloride channel (hCLCA1) in regulating mucus overproduction, as well as Lomucin¿s potential to treat additional respiratory diseases characterized by mucus overproduction.
¿ Introgen Therapeutics Inc., of Austin, Texas, reported that results of preclinical studies in melanoma have been published in the October 2001 issue of the International Journal of Cancer in a manuscript titled ¿Down-Regulated Melanoma Differentiation Associated Gene (MDA-7) Expression in Human Melanomas.¿ Researchers conclude that the MDA-7 protein is present in normal melanocytes (cells responsible for pigmentation in the skin) and early stages of melanoma tumors. However, as the cancer advances, MDA-7 is lost. In the highly aggressive metastatic disease, MDA-7 is virtually nonexistent, demonstrating that MDA-7 is a key tumor suppressor gene whose function is lost as melanoma tumors grow more aggressively.
¿ MedImmune Inc., of Gaithersburg, Md., licensed worldwide rights to EphA2 technology from Purdue Research Foundation, a division of Purdue University. MedImmune will be responsible for developing, manufacturing and commercializing therapeutics that target EphA2, products that potentially will be used to treat a variety of aggressive tumors, including breast, colon, prostate, lung and skin cancers, as well as to prevent metastasis. Purdue will receive certain up-front payments and potential milestones and royalties.
¿ Microcide Pharmaceuticals Inc., of Mountain View, Calif., and The Althexis Company Inc., of Waltham, Mass., said Microcide shareholders approved the merger of Microcide and Althexis to form Essential Therapeutics Inc. The company will continue to trade on Nasdaq under the new symbol ETRX, and Mark Skaletsky will be chairman and CEO. Also approved was a $60 million private equity funding. The merged company received $57 million Wednesday in a first closing and anticipates receiving the balance of the funding in the next few days. (See BioWorld Today, July 31, 2001.)
¿ Neose Technologies Inc., of Horsham, Pa., said its board of directors authorized a stock repurchase program of up to 1 million shares of its common stock. Shares will be repurchased in the open market at times and prices considered appropriate by the company. The program is effective immediately. As of Sept. 30, Neose had 14,052,814 shares outstanding.
¿ Paracel Inc., of Pasadena, Calif., a business unit of Celera Genomics Group, of Rockville, Md., introduced the Paracel GenomeAssembler, a software package for all types of sequence assembly including whole genome shotgun projects. The GenomeAssembler provides a fully automated pipeline that performs all steps required for sequence reconstruction.
¿ Sequenom Inc., of San Diego, reported advancements in the rapid analysis and quality control of live viral vaccines using its MassARRAY technology. Sequenom completed a collaboration with the FDA and Aventis Pasteur SA, of Strasbourg, France, which demonstrated the use of MassARRAY technology to accelerate and improve the accuracy of genetic analyses of live viruses. Results were published in the Proceedings of the National Academy of Sciences in an article titled ¿Quantitative mutant analysis of viral quasispecies by chip-based matrix-assisted laser desorption/ionization time-of-flight mass spectrometry.¿
¿ Theratechnologies Inc., of Saint Laurent, Quebec, said that two European clinical sites, in Belgium and the UK, have been added to its ongoing, multicenter Phase II trial in sleep maintenance insomnia for its growth hormone-releasing factor analogue, ThGRF (TH 9507), and that enrollment has begun in Europe. This brings the number of clinical sites involved to seven. The 90-patient study is parallel design, double blind and placebo controlled, with patients receiving one of two doses of ThGRF or a placebo over two weeks.