• Agilent Technologies Inc., of Palo Alto, Calif., formed a collaboration with the Translational Genomics Research Institute (TGen), of Phoenix, on an application for oligonucleotide microarray technology, called comparative genomic hybridization, that could enhance the ability to identify and locate genetic alterations that contribute to cancer. TGen gains early access to Agilent's CGH microarrays and computational tools for analyzing and visualizing CGH data and combined CGH and gene expression profile data. The effort builds on a six-year, ongoing collaboration on gene expression profiling.

• Antisense Therapeutics Ltd., of Melbourne, Australia, and Isis Pharmaceuticals Inc., of Carlsbad, Calif., reported the results of a Phase I study of ATL-1102. It was well tolerated and a specific dose was selected for Phase II development. ATL-1102 is a second-generation antisense inhibitor of VLA-4 (very-late antigen-4). Inhibition of VLA-4 has been shown to have positive effects in multiple animal models of inflammatory disease, including MS, the company said.

• Applied Imaging Corp., of San Jose, Calif., reported the opening of its new corporate headquarters in San Jose. The company's 24,000-square-foot facility houses all corporate functions and features manufacturing and warehousing facilities. It also will house sales, marketing and customer service for North America. Its previous headquarters were located in Santa Clara, Calif.

• Arakis Ltd., of Little Chesterford, UK, initiated a Phase IIa trial in 96 rheumatoid arthritis patients to study the pharmacokinetics, safety and tolerability of a range of doses of AD452, a disease-modifying treatment for early stage RA. The trial is a double-blind, placebo-controlled, parallel-group study in patients who already are receiving stable background therapy. AD452 is the single isomer of a drug that currently is marketed in a different indication.

• Aspreva Pharmaceuticals Corp., of Victoria, British Columbia, began a global Phase III study of CellCept (mycophenolate mofetil) for myasthenia gravis. The randomized, placebo-controlled trial will enroll 136 patients at 22 sites in five countries. Results are expected in 2006. Aspreva acquired global rights last year from F. Hoffmann-La Roche Ltd., of Basel, Switzerland, to develop CellCept for all autoimmune conditions. CellCept is indicated in the U.S. for the prevention of rejection in kidney, liver and cardiac transplant patients, as part of a combination therapy. The FDA first approved it in 1995.

• BioSpecifics Technologies Corp., of Lynbrook, N.Y., signed a development and license agreement with Auxilium Pharmaceuticals Inc., of Norristown, Pa., for an exclusive worldwide license to develop and commercialize certain therapeutic applications of BioSpecifics' enzyme. Auxilium will pay license fees, milestone fees and royalties, as well as a fee for the manufacture of the product. BioSpecifics will manufacture and package the product for all uses worldwide.

• Cell Signaling Technology Inc., of Beverly, Mass., entered an agreement with AstraZeneca plc, of London, to perform a pilot study profiling certain AstraZeneca compounds with CST's Global Phospho-Signature technology to discover biomarkers of protein tyrosine kinase target inhibition. CST's phospho-proteomics technology combines immunoaffinity purification and mass spectroscopy to determine cellular PTK phosphorylation profiles.

• Chiron Corp., of Emeryville, Calif., said the Chiron Foundation has designated the following 11 organizations as recipients of $400,000 in the foundation's inaugural grants: Foundation for America's Blood Centers, Hep C Connection, Sustainable Healthcare Enterprise Foundation, VillageReach, the Heuga Center, Friends of Cancer Research, National Children's Cancer Society, ARCS Foundation, Teach for America, Center for the Education of the Infant Deaf and Treehouse.

• Competitive Technologies Inc., of Fairfield, Conn., said a U.S. Court of Appeals for the Federal Circuit has affirmed the November 2002 decision of the Colorado U.S. District Court that Laboratory Corp. of America Holdings willfully contributed to and induced infringement of CTT's homocysteine assay patents. The ruling upholds the decision that found in favor of CTT, the University of Colorado and Columbia University, and its licensee Metabolite Laboratories Inc. CTT expects to receive about $1.2 million of the $2.1 million awarded. Metabolite will receive $4.5 million.

• Copernicus Therapeutics Inc., of Minneapolis, presented data at the 7th annual meeting of the American Society of Gene Therapy showing that compacted DNA nanoparticles can be successfully formulated as aerosol mists suitable for treating the lungs of cystic fibrosis patients. It also showed that compacted DNA can be repetitively dosed in animals without any falloff in effectiveness, and that there is no significant size limitation to the DNA drug payload its nanoparticle technology can deliver.

• Cortex Pharmaceuticals Inc., of Irvine, Calif., said funding to Wake Forest University researchers was extended by the Defense Advanced Research Projects Agency for additional testing of Ampakine compounds to reverse the effects of sleep deprivation in nonhuman primates. The model measures decrements in cognitive performance and reaction time after monkeys have been deprived of sleep for 30 to 36 hours.

• Crucell NV, of Leiden, the Netherlands, and its contract manufacturer, DSM Biologics, of Groningen, the Netherlands, signed a PER.C6 research license agreement with PanGenetics BV, of Sittard, the Netherlands. PanGenetics will use the PER.C6 cell line for preclinical manufacturing of certain recombinant monoclonal antibody products. Crucell and DSM will receive an up-front payment and annual maintenance fees.

• CV Therapeutics Inc., of Palo Alto, Calif., said the initial purchasers of its 2.75 percent senior subordinated convertible notes due 2012 exercised their option to purchase an additional $25 million aggregate principal amount of the notes. The closing of the purchase option increases the aggregate principal amount to $150 million. The company may redeem all or a portion of the notes any time after May 20, 2009.

• DUSA Pharmaceuticals Inc., of Wilmington, Mass., began a pilot Phase II trial to treat high-grade dysplasia (HGD) within Barrett's esophagus, using Levulan photodynamic therapy (PDT). In a previous trial, five patients who were followed for a median of 12 months after the last Levulan PDT treatment demonstrated complete ablation of HGD, with no strictures reported.

• Entelos Inc., of Foster City, Calif., said it will develop an in silico model of the non-obese diabetic mouse, the primary animal model used to study Type I diabetes. The model will be built in collaboration with the American Diabetes Association and a scientific advisory board they selected.

• Enzo Biochem Inc., of Farmingdale, N.Y., filed a lawsuit in the U.S. District Court for the District of Connecticut against Applera Corp. and its subsidiary Tropix Inc., alleging patent infringement arising out of the misappropriation of Enzo's technologies related to DNA sequencing systems, and other products. Four of the patents are licensed to Enzo by Yale University, which also is named as a plaintiff.

• ESP Pharma Inc., of Edison, N.J., entered into an agreement to acquire from Orphan Therapeutics LLC, of Lebanon, N.J., rights to intravenous terlipressin, a therapeutic in Phase III trials for Type I hepato-renal syndrome. ESP Pharma agreed to up-front and milestone payments, plus future royalties on net sales, in exchange for exclusive marketing and distribution rights in the U.S., its territories, and Canada. Orphan Therapeutics agreed to conduct the pivotal Phase III trial, prepare the new drug application and pursue orphan drug designation in the U.S. in collaboration with ESP Pharma.

• Genelabs Technologies Inc., of Redwood City, Calif., decided to withdraw its European marketing authorization applications for its lupus drug, Anastar, following a list of questions from the European Medicines Agency and the indication that the data submitted would not support approval. Genelabs intends to work with European authorities to address the issue and resubmit an application later. Anastar (prasterone, Prestara in the U.S.) received an FDA approvable letter in 2002, and is in a confirmatory Phase III trial to support final approval. Data are expected in the fourth quarter. (See BioWorld Today, Sept. 3, 2002.)

• Generex Biotechnology Corp., of Toronto, presented data at the American Diabetes Association's 64th annual meeting and scientific sessions in Orlando, Fla., of Oralin, a buccal spray insulin, in comparison to s.c. insulin and placebo spray in patients with Type I diabetes. Data showed that Oralin has a faster onset and a shorter duration of action compared to s.c. regular insulin, with the main effect in the first two hours.

• Illumina Inc., of San Diego, entered a deal with University of Southern California in Los Angeles for the purchase and installation of an Illumina BeadLab in the university's Zilkha Neurogenetic Institute at the Keck School of Medicine. BeadLab is a production-scale SNP genotyping laboratory.

• Ilypsa Inc., of Santa Clara, Calif., formerly named Symyx Therapeutics Inc., said Scott Rocklage joined its board as executive chairman. Ilypsa recently moved into a 21,000-square-foot research and development facility in Santa Clara.

• Introgen Therapeutics Inc., of Austin, Texas, reported the presentation of data that demonstrated the flexibility and anticancer effects of its oncolytic viruses. The results of several preclinical studies showed the viruses could be modified to target tumor cells and to produce proteins that kill cancer cells. Also presented were data on a newly developed biology of human cancer that may be used to evaluate the anticancer effects and safety profile of oncolytic viruses. The data were presented at the 7th annual meeting of the American Society of Gene Therapy in Minneapolis.

• Invitrogen Corp., of Carlsbad, Calif., reported the upcoming launch of the Yeast ProtoArray. The high-throughput technology is designed to allow screening of thousands of proteins in a miniaturized format that is compatible with standard laboratory equipment.

• Isotechnika Inc., of Edmonton, Alberta, formalized a manufacturing agreement with Lonza Group Ltd., of Basel, Switzerland. Lonza will manufacture trans-ISA247 for use in Isotechnika's upcoming clinical trials. ISA247 is an immunosuppressant that has completed a Phase II trial for psoriasis and Phase IIa trial for kidney transplantation.

• Maxygen Inc., of Redwood City, Calif., and Biovitrum AB, of Stockholm, Sweden, signed an agreement for the manufacture of Maxygen's interferon beta material for Phase I and Phase II clinical development. The companies said Maxygen has designed an improved interferon beta product candidate for the treatment of multiple sclerosis with a profile designed to be superior to currently marketed products.

• Merix Bioscience Inc., of Durham, N.C., began a Phase I/II study of its RNA-loaded autologous dendritic cell vaccine at five clinical sites in the U.S. and Canada. The therapy is being studied as a treatment for kidney cancer. The vaccine consists of dendritic cells taken from the patient's body and infused with amplified RNA from the patient's tumor.

• Morphotek Inc., of Exton, Pa., signed a research agreement with Tanox Inc., of Houston, for the use of Morphotek's SIP Technology to develop universal high-titer mammalian cell line hosts for the commercial manufacturing of therapeutic antibody products. Morphotek will receive an up-front payment and research fees, research milestones upon successful achievement of program goals, and royalties on sales of such products.

• Nuvelo Inc., of Sunnyvale, Calif., successfully completed an interim analysis of the first 48 patients in the Phase II trial of alfimeprase to treat venous catheter occlusions. The Data Safety and Monitoring Board and the Trial Operations Committee recommended the trial continue to enroll in the two highest dose groups. The multicenter, randomized, double-blind study began in June 2003 and has a target enrollment of 90 patients.

• Palatin Technologies Inc., of Cranbury, N.J., said a clinical study of PT-141 and Viagra indicated that co-administration resulted in an increased degree of erectile activity, relative to Viagra alone, and that patients reported a better quality of erection relative to Viagra alone. PT-141 is Palatin's lead drug candidate under development for the treatment of male and female sexual dysfunction.

• Pharmion Corp., of Boulder, Colo., filed a shelf registration statement for a follow-on offering of 4 million shares of its common stock. Pharmion also expects to grant the underwriters an option to purchase an additional 600,000 shares to cover overallotments. Pharmion is focused on acquiring, developing and commercializing products for the treatment of hematology and oncology patients. Pharmion raised $84 million in its IPO in November, and last month gained FDA approval of Vidaza for treating myelodysplastic syndromes

• Pozen Inc., of Chapel Hill, N.C., was served with several class-action lawsuits, alleging the company violated federal securities laws by issuing a series of materially false and misleading statements to the market between July 31, 2003, and May 28, 2004. Earlier this month, Pozen received its second not-approvable letter for a migraine drug, MT-100. The first not-approvable letter came last fall for MT-300. (See BioWorld Today, Oct. 21, 2003, and June 2, 2004.)

• Sepracor Inc., of Marlborough, Mass., presented six Estorra brand eszopiclone posters at the 18th annual meeting of the Associated Professional Sleep Societies in Philadelphia. Data showed eszopiclone significantly improved patient reports of sleep onset, wake time after sleep onset and total sleep time compared with placebo in both elderly and non-elderly patients. Additional results showed eszopiclone significantly improved median sleep latency, sleep quality and depth of sleep compared with placebo.

• St. Jude Children's Research Hospital, of Memphis, Tenn., said the development of a mouse model that closely mimics the human eye cancer retinoblastoma gives investigators a way to test new therapies for the disease. Researchers eliminated the gene Rb1, as well as two other cancer-suppressing genes, p107 and p53, in developing the model.

• Teva Pharmaceutical Industries Ltd., of Jerusalem, said new data published in the April 27, 2004, edition of Neurology on Copaxone (glatiramer acetate injection) showed that it significantly reduced brain atrophy in patients with relapsing-remitting multiple sclerosis. The study, which included 207 patients, used a post hoc analysis of a fully automated, normalized technique for analyzing MRI scans.

• Vertex Pharmaceuticals Inc., of Cambridge, Mass., initiated a Phase I trial of VX-950, an oral protease inhibitor for the treatment of hepatitis C virus infection. About 35 healthy subjects will participate in the study. Separately, Vertex and GlaxoSmithKline plc, of London, reported data on the protease inhibitor 640385 (VX-385), showing it appears to be active against HIV, including strains that have become resistant to multiple protease inhibitor drugs. Those data were presented at the XIII International HIV Resistance Workshop in Los Cabos, Mexico.

• ViroPharma Inc., of Exton, Pa., began a proof-of-concept clinical study with HCV-086, a hepatitis C antiviral compound that ViroPharma is co-developing with Wyeth, of Madison, N.J. The randomized, double-blind, placebo-controlled trial will involve 96 patients in the U.S. The company hopes to move the product into Phase II testing in 2005.

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