• Acacia Research Corp., of Newport Beach, Calif., said its CombiMatrix Group is launching the CustomArray 12K DNA expression array, offering researchers the ability to order a fully customizable array with more than 12,000 sites. The company said that the CustomArray products enable researchers to study any combination of genes from any genome on a single chip.

• Actelion Ltd., of Allschwil, Switzerland, said guidelines published in the Journal of the American College of Cardiology graded Tracleer (bosentan) with the highest level of evidence for treating patients with idiopathic pulmonary arterial hypertension Class III and pulmonary arterial hypertension related to connective tissue disease. The guidance stemmed from an international symposium on pulmonary arterial hypertension.

• Affymetrix Inc., of Santa Clara, Calif., launched the NimbleExpress Array Program, an extension to its line of custom microarrays, to provide researchers with a method of designing customized expression arrays for smaller scale studies or pilot experiments. NimbleExpress arrays use the company's strategy of multiple pairs of perfect match and mismatch oligos per transcript, the company said, noting that the NimbleExpress arrays are useful to study expression of up to 12,000 transcripts on a single array.

• AGT Biosciences Ltd., of Melbourne, Australia, and ChemGenex Therapeutics Inc., of Menlo Park, Calif., completed their merger transaction. Stockholders of both companies approved the merger and merger-related proposals, and all closing conditions were satisfied. The combined company will be known as ChemGenex Pharmaceuticals Ltd. and will continue trading on the Australian Stock Exchange. In April, the companies said AGT would issue about 28 million shares valued at $10.2 million to ChemGenex shareholders. (See BioWorld Today, April 28, 2004.)

• Amrad Corp. Ltd., of Melbourne, Australia, said it would spin out its anti-infectives drug portfolio into a company called Avexa Ltd. The spinout will be conducted by a demerger to existing Amrad shareholders, who will become entitled to shares comprising about 80 percent of the demerged company, while Amrad will retain about 19.9 percent. Amrad will invest $12 million in Avexa as funds for initial working capital to complete proof-of-concept animal trials for each of its three anti-infective research projects. It is planned that Avexa would list on the Australian Stock Exchange later this year with a market capitalization of $24 million.

• Angstrom Pharmaceuticals Inc., of San Diego, began a Phase II trial of A6 in preventing clinical relapse in patients with ovarian cancer. The U.S.-based, multicenter study, which will enroll 48 to 60 patients, is designed to assess the compound's safety and efficacy in asymptomatic women in clinical remission who have an elevated CA-125 tumor marker level following successful first-line treatment.

• Biosystemix Ltd., of Kingston, Ontario, will work with a consortium of genomics researchers called S2K to develop computational models that predict disease susceptibility and progression, and therapeutic response, as part of a program funded by Genome Canada and Genome Quebec. Biosystemix employs data-mining algorithms to discover relationships that link predictive marker sets to clinical outcomes and phenotypes.

• Cypress Bioscience Inc., of San Diego, said Phase II data related to the use of milnacipran for fibromyalgia syndrome were reported at the Collegium Internationale Neuro-Psychopharmacologicum meeting in Paris. The product is the subject of a collaborative development and marketing agreement with Forest Laboratories Inc., of New York.

• Cytogen Corp., of Princeton, N.J., said data reported at the Society of Nuclear Medicine meeting in Philadelphia pointed to advances in prostate cancer imaging using Prostascint. Among the findings, researchers at Johns Hopkins Medical Institutions in Baltimore and Emory University in Atlanta said that fusion imaging with the diagnostic imaging agent resulted in improved image quality and quantitative information about patients' disease.

• Cytomedix Inc., of Little Rock, Ark., said two federal courts entered judgments in its favor related to a patent suit brought by 21st Century Wound Care and Advanced Therapy LLC and its owner, James Gandy. Cytomedix's Knighton patent, which covers the use of compositions containing platelet releasates for wound-healing purposes, was found valid and enforceable. The court declared that 21st Century and Gandy had infringed the patent and enjoined them, effective immediately and continuing through patent expiration in November 2009, from making, using, offering or selling within the U.S. autologous cellular therapies, platelet gel products, or any other processes or products that infringe the claims of the patent, Cytomedix said.

• Draximage Inc., of Mississauga, Ontario, the radiopharmaceutical subsidiary of Draxis Health Inc., featured its diagnostics products, Fibrimage and Infecton, in a scientific colloquium held in conjunction with the 51st annual meeting of the Society of Nuclear Medicine in Philadelphia June 19-23. Draximage also launched its recently approved skeletal imaging agent, MDP-25, at the SNM meeting. Fibrimage, in Phase III development, is a new molecular imaging agent for the diagnosis of deep-vein thrombosis. Fibrimage binds specifically to new clots and is able to image active clots that are more likely to result in the formation of potentially fatal pulmonary emboli, the company said.

• Genmab A/S, of Copenhagen, Denmark, said the FDA accepted its investigational new drug application to start an open-label, dose-escalation Phase I/II study with HuMax-CD20 to treat patients with relapsed or refractory chronic lymphocytic leukemia. Thirty-two patients will be treated for four weeks. The total follow-up period is 12 months from treatment start, and the primary endpoint of the trial is objective response over the period from screening to week 19. Genmab will initiate the study this summer.

• Guilford Pharmaceuticals Inc., of Baltimore, plans to file a prospectus supplement with the SEC related to an underwritten offering of 10 million common shares under an existing shelf registration statement. In connection with the offering, Guilford expects to grant the underwriters an option to purchase up to 1.5 million additional shares to cover overallotments. UBS Investment Bank is acting as sole book-running manager, with co-management from CIBC World Markets Corp. and Citigroup Global Market Inc.

• Immunomedics Inc., of Morris Plains, N.J., said its therapeutic product candidates, as well as those of its IBC Pharmaceuticals Inc. subsidiary, were the subject of nine presentations at the Society of Nuclear Medicine meeting in Philadelphia. Among the findings were data from two Phase I studies showing that 90-Yttrium-labetuzmab targets tumors. The studies also found acceptable normal organ radiation doses and a maximum tolerated dose for a single administration of 25 mCi/m-2.

• Intradigm Corp., of Rockville, Md., was awarded a Phase I Small Business Innovation Research grant by the National Eye Institute, a unit of the National Institutes of Health in Bethesda, Md., to support development of the company's lead anti-angiogenesis siRNA therapeutic product. Intradigm noted that the product has demonstrated an anti-angiogenetic effect through a dual targeting to neovasculature in eyes and factors in the VEGF pathway.

• Ionix Pharmaceuticals Ltd., of Cambridge, UK, began a Series C equity financing with new investments from existing investors Apax Partners and The Wellcome Trust. The company said the financing would enable the development of calcium and sodium channel blocker programs through to clinical proof of concept.

• Nautilus Biotech, of Evry, France, and Serono SA, of Geneva, entered an agreement to develop next-generation therapeutic proteins with improved biological, pharmacological and clinical profiles. Nautilus will apply its technology for improving biotherapeutics to design new protein variants and validate them in vitro and in vivo. Serono would select protein variants created and validated by Nautilus and bring them through preclinical and clinical development to market. Financial terms were not disclosed.

• NovaDel Pharma Inc., of Flemington, N.J., submitted a new drug application for marketing approval of an aerosol nitroglycerin lingual spray for acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease. The product is delivered via a metered-dose dispenser.

• Oscient Pharmaceuticals Corp., of Waltham, Mass., completed enrollment in a Phase II trial of Ramoplanin in Clostridium difficile-associated diarrhea. The company anticipates submitting full results for publication or presentation at an upcoming medical conference. The three-armed, noninferiority study was designed to assess whether oral Ramoplanin is at least as effective as oral vancomycin.

• Paradigm Genetics Inc., of Research Triangle Park, N.C., received a Phase I/II Small Business Innovation Research contract from the National Institute of Environmental Health Sciences, a unit of the National Institutes of Health in Bethesda, Md. It will support the company's efforts to discover biochemicals in urine, serum and liver tissue that predict the early onset of drug-induced liver injury. Paradigm will conduct preclinical studies on three compounds known to cause liver damage, using mass spectrometry to measure changes in hundreds of small molecular-weight biochemicals that might be linked to liver toxicity. Separately, Paradigm said data reported at last week's symposium of the Society of Toxicologic Pathology demonstrated that its automated pathology software could distinguish between normal and diseased liver tissue and detect the presence and degree of hepatocellular hypertrophy. Other data showed that the automated pathology software can enhance a pathologist's interpretation of tissue response by identifying tissue features.

• Quark Biotech Inc., of Fremont, Calif., discovered the function of a family of proteins called sestrins, which regulate antioxidant defense and modulate a cell-signaling pathway. The discovery was published in Science (Vol. 304). Quark, along with collaborators, discovered that sestrins regulate antioxidant defense and modulate signaling involved in cell proliferation and cell death.

• Salix Pharmaceuticals Ltd., of Raleigh, N.C., said its board approved a 3-for-2 stock split of the company's common stock. As a result, stockholders will receive one additional common share for every two shares held on the record date of June 30. As of June 21, Salix had about 24 million shares outstanding. Upon completion of the split, the number of outstanding shares will increase to about 36 million. Salix develops and markets prescription pharmaceutical products for the treatment of gastrointestinal diseases.

• SanguiBioTech GmbH, of Witten, Germany, said it would jointly develop a hemoglobin wound spray based on its artificial oxygen carrier with an undisclosed German pharmaceutical company. The pharmaceutical firm will acquire knowledge, rights and patents from Sangui, while both partners plan to prepare and promote international regulatory clearance of the wound spray. It would be internationally marketed by the pharmaceutical company, and Sangui would participate in future sales through royalties.

• Schering-Plough Corp., of Kenilworth, N.J., said Remicade (infliximab) received European approval as first-line therapy for the treatment of early rheumatoid arthritis. Remicade, in combination with methotrexate, is indicated for the reduction of signs and symptoms, as well as the improvement in physical function in patients with severe, active and progressive disease not previously treated with methotrexate or other disease-modifying antirheumatic drugs. Schering-Plough markets the product outside the U.S., while Centocor Inc., of Malvern, Pa., has exclusive marketing rights in the U.S.

• Senetek plc, of Napa, Calif., granted an exclusive license to allow Ardana Bioscience Ltd., of Edinburgh, Scotland, to manufacture and market Senetek's erectile dysfunction drug treatment in the European Union and European Free Trade Area. Ardana assumes full responsibility for completing the European drug regulatory process for Invicorp and seeking national marketing approvals throughout Europe. The product has been approved in Denmark, which has been chosen as the reference member state for mutual recognition in Europe. Senetek will receive royalties based on net sales of Invicorp plus milestone payments upon regulatory approvals in specified major markets and achievement of unspecified cumulative net sales in Europe.

• Targeted Molecular Diagnostics LLC, of Westmont, Ill., expanded its collaborative work with researchers at the University of Texas M.D. Anderson Cancer Center in Houston. The specialty reference lab and investigators from the school will study the relevance of cyclin E in predicting the outcome for patients undergoing liver surgery for metastasis from colon cancer. In the past, they have jointly studied cell-cycle regulators in breast cancer.

• Therion Biologics Corp., of Cambridge, Mass., began a Phase III trial of Panvac-VF for metastatic pancreatic cancer in patients who have not responded to treatment with gemcitabine. The primary endpoint of the study, which will enroll 250 patients at 50 to 60 U.S.-based sites, will be overall survival, compared with palliative chemotherapy or best supportive care. It is being conducted under the guidance of a special protocol assessment from the FDA. (See BioWorld Today, May 24, 2004.)

• Viragen Inc., of Plantation, Fla., said an article reporting on its Avian Transgenic Biomanufacturing program was published in EMBO reports of the European Molecular Biology Association in Heidelberg, Germany. The article reports data that demonstrate that lentiviral vectors can be used to generate transgenic lines with an efficiency in the order of 10- to 100-fold higher than any previously published method.

• Xenova Group plc, of Slough, UK, received regulatory authorization for its clinical trials manufacturing facility in Cambridge, UK. The approval applies to the company's own products and those manufactured under contract for clients, allowing Xenova to manufacture and release investigational medicinal products in compliance with the new clinical trials directive released last month.

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