• Acacia Research Corp., of Newport Beach, Calif., entered a global distribution agreement with VWR International Inc., of West Chester, Pa., to distribute CustomArrays and CatalogArrays for CombiMatrix. CombiMatrix's CustomArrays platform consists of DNA probes built on semiconductor chips using CombiMatrix's technology and methods from which two classes of products are derived: CustomArrays, with user-defined DNA content, and CatalogArrays, with DNA content pre-designed by CombiMatrix.

• Affymetrix Inc., of Santa Clara, Calif., launched its GeneChip-compatible applications program to provide customers software solutions for biomedical research and development integrated with the GeneChip platform.

• Alnylam Pharmaceuticals Inc., of Cambridge, Mass., and Isis Pharmaceuticals Inc., of Carlsbad, Calif., signed a co-exclusive license agreement with Stanford University related to the discovery and development of therapeutic products for treating hepatitis C virus infection by inhibiting liver-specific microRNA. Data published Sept. 2 in Science demonstrated that the microRNA, known as miR-122, are needed for HCV replication in mammalian cells, suggesting that the antagonism of miR-122 might inhibit HCV. Alnylam and Isis said the recent licensing falls under a March 2004 agreement, in which the companies decided to work jointly to consolidate intellectual property in the microRNA field.

• Angiotech Pharmaceuticals Inc., of Vancouver, British Columbia, entered an agreement to acquire Afmedica Inc., a private company developing perivascular technology using the drug rapamycin to treat peripheral vascular disease, coronary artery disease and end-stage renal disease. Terms of the transaction were not disclosed, and the deal is expected to conclude during the fourth quarter.

• Axcan Pharma Inc., of Mt. Saint-Hilaire, Quebec, said data from its five-year follow-up observation analysis of patients with high-grade dysplasia associated with Barrett's esophagus showed that those treated with the company's Photofrin photodynamic therapy in conjunction with omeprazole had a reduced occurrence of esophageal cancer. Results confirmed that Photofrin PDT plus omeprazole was superior to omeprazole alone in preventing the progression to cancer, with cancer occurring in 15 percent of the combination group and in 29 percent of the group that received only omeprazole. Those data were reported at the World Congress of Gastroenterology 2005 in Montreal.

• Biolex Therapeutics Inc., of Pittsboro, N.C., doubled manufacturing capacity, expanding preclinical and clinical production space to more than 13,000 square feet. The company said it will use the additional capacity to develop and manufacture therapeutic proteins for partners, including Malvern, Pa.-based Centocor Inc. and Princeton, N.J.-based Medarex Inc., using its LEX System, a protein-expression system that relies on the aquatic plant Lemna for production. The expansion also will benefit Biolex's controlled-release formulation of recombinant human alpha interferon, Locteron, expected to begin Phase I testing this year.

• Biolog Inc., of Hayward, Calif., introduced its first Phenotype MicroArray cell-based assays for use with mammalian cell lines. The mammalian cell capability is added to its list of uses for a variety of research applications, including drug discovery, functional genomics and cellular toxicology.

• Biomira Inc., of Edmonton, Alberta, completed enrollment of a 20-patient Phase II, single-arm, multicenter, open-label study of BLP25 liposome vaccine, which is being developed with Merck KGaA, of Darmstadt, Germany. The trial will assess the safety of the formulation of L-BLP25 that the companies plan to use in the upcoming Phase III study. Initial results from the trial involving men and women with non-small-cell lung cancer from eight clinical trial sites in Canada are expected before the end of 2005.

• Biovitrum AB, of Stockholm, Sweden, said its candidate drug for glaucoma, BVT.28949, entered a Phase I trial this month. The drug was developed within Biovitrum, and the trial will include about 60 healthy volunteers. The study is expected to be completed later in the year.

• CardioVascular BioTherapeutics Inc., of Henderson, Nev., said its investigational new drug application was allowed and the company was authorized to begin Phase I trails in diabetic patients who have foot ulcers and/or open leg wounds. The company is planning on testing two doses of its wound-healing agent, Cardio Vascu-Grow for topical application.

• Carrington Laboratories Inc., of Irving, Texas, said its subsidiary, DelSite Biotechnolgoies Inc., filed a drug master file with the FDA for the manufacturing of GelSite polymer and its use in nasal and other mucosal applications. GelSite is a drug delivery technology being developed to deliver vaccines, proteins and peptide drugs.

• CeMines Inc., of Golden, Colo., entered an agreement to provide its CellCorrect LAb Detection Test Kits to Denver-based Colorado Heart & Body Imaging LLC for clinical studies relating to patient serum biomarkers and imaging. The LAb kits are designed to detect altered autoimmunity and associated patterns of lung cancer-related auto-antibodies present in the blood stream. Terms were not disclosed.

• Cephalon Inc., of Frazer, Pa., received an approval letter from the FDA to market a new sugar-free formulation of Actiq (oral transmucosal fentanyl citrate). The sugar-free formulation is bioequivalent to the available product and will be marketed for the same indication, breakthrough pain in cancer patients. The company expects to launch it in the first half of 2006.

• CuraGen Corp., of New Haven, Conn., and TopoTarget A/S, of Copenhagen, Denmark, started patient dosing in a Phase Ib, open-label, multicenter, proof-of-concept trial evaluating PXD101, a small-molecule histone deacetylase inhibitor, to treat advanced solid tumors, including ovarian cancer. The goal of the proof-of-concept trial is to establish the maximum tolerated dose of PXD101 used in combination with carboplatin and/or paclitaxel in up to 30 patients with advanced solid tumors. Once the maximum tolerated dose is established, an additional 15 ovarian cancer patients in need of relapse treatment will be enrolled.

• Cytomedix Inc., of Rockville, Md., said the previously reported preliminary analysis from a clinical trial testing the AutoloGel platelet releaseate therapy system in diabetic foot ulcers does not reflect a full and complete analysis of initial data, and further review is needed to determine the product's efficacy in wound healing. The company announced Sept. 12 that early analysis appeared to indicate that efficacy, determined by total wound closure, might be similar to the standard of therapy used as a control during the trial. Cytomedix also reported that no product-related adverse effects were observed.

• Evotec Technologies GmbH, of Hamburg, Germany, and Genedata AG, of Basel, Switzerland, entered an agreement to combine their strengths in the area of high-content and high-throughput screening. The companies expect synergistic effects in combining Evotec's instrumentation software, Acapella, with Genedata's software system, Genedata Screener.

• Helix BioPharma Corp., of Aurora, Ontario, received approval from Sweden's drug regulatory authority, the Medical Products Agency, to conduct a Phase II trial of topical interferon alpha-2b in patients with ano-genital warts who are positive for infection with the human papillomavirus (HPV). The trial is intended to assess the efficacy and safety of the product compared with placebo. Topical interferon alpha-2b is in a Phase II study in Germany to treat low-grade squamous intraepithelial lesions in women who are positive for HPV infection.

• Inovio Biomedical Corp., of San Diego, was awarded an appropriation of about $1 million by the U.S. Department of Defense for the development of its gene delivery electroporation technology for application in vaccination against infectious diseases, including potential bioterrorism agents.

• Introgen Therapeutics Inc., of Austin, Texas, said preclinical studies of its cancer drug, INGN 007, demonstrated a favorable safety profile in animal models. Results were presented at the 13th International Conference on Gene Therapy of Cancer. INGN 007 is an oncolytic virus designed to infect cancer cells and destroy them through replication.

• Ligand Pharmaceuticals Inc., of San Diego, was informed that the SEC opened a nonpublic formal investigation in connection with the company's financial restatements as of, and for the years ended Dec. 31, 2002, and 2003, and for the quarters of 2003, and the first three quarters of 2004. Ligand said these matters have been the subject of an informal SEC inquiry, and that the company continues to cooperate.

• Lorus Therapeutics Inc., of Toronto, formed a steering committee assessment of progress for its program of six National Cancer Institute-sponsored clinical studies of GTI-2040 in multiple cancer indications. The assessment included an investigators meeting, which reviewed all safety and interim efficacy data, and follow-up data review activities on individual studies. All of the studies are progressing without unacceptable toxicity, it said.

• Nabi Biopharmaceuticals, of Boca Raton, Fla., was awarded a $4.1 million grant by the U.S. National Institute on Drug Abuse for partial funding of the company's development program for NicVAX (nicotine conjugate vaccine). Nabi is developing the vaccine to treat nicotine addiction and prevent smoking relapse.

• Novelos Therapeutics Inc., of Newton, Mass., will be collaborating on research with the Medical University of South Carolina to add to the understanding of how its development-stage products NOV-002 and NOV-205 act at a cellular and molecular level to provide the benefits seen in cancer and hepatitis C patients, respectively. The research will aid design and execution of clinical studies, facilitate interactions with the FDA and other regulatory authorities, and provide for further growth of Novelos' product portfolio.

• Novogen Ltd., of Stamford, Conn., reported positive results from a Phase Ib trial in which the Novogen cardiovascular investigational drug trans NV-04 was found to show significant improvement in blood pressure and arterial stiffness in patients at risk for heart attack and stroke. The study tested NV-04, an isoflavonoid compound synthesized by Novogen, in 25 middle-aged men and women who were overweight and suffered from at least two of the following conditions: abnormal blood fats, high blood glucose or raised blood pressure.

• Open Biosystems Inc., of Huntsville, Ala., completed coverage of the mouse genome with RNAi triggers adapted with microRNA sequences, extending the company's portfolio of Expression Arrest products. The mouse library targets more than 28,000 mouse genes with multiple shRNA(mir) constructs per gene.

• Oragenics Inc., of Alachua, Fla., named Robert Zahradnik president and CEO. A co-founder of the company, Zahradnik served as a member of the board from November 1996 until July 2005, when he resigned to serve as acting president and CEO. Oragenics has several products in development, including a topical product aimed at preventing tooth decay in Phase I trials and MU 1140, a preclinical antibiotic with activity against Gram-positive bacteria.

• Pharmacyclics Inc., of Sunnyvale, Calif., said it is enrolling patients in an open-label Phase II trial of Xcytrin (motexafin gadolinium) injection, the company's lead cancer therapeutic, in combination with whole-brain radiation therapy and stereotactic radiosurgery for the treatment of brain metastases from solid tumors. The trial is expected to involve 45 patients.

• Pro-Pharmaceuticals Inc., of Newton, Mass., submitted a clinical protocol for a Phase II study of its lead carbohydrate compound Davanat with chemotherapeutic agent 5-fluorouracil for first-line treatment of patients with bile duct cancer. The FDA approved a "compassionate use" investigational new drug application to continue treating a patient with bile duct cancer and liver metastases who participated in the Phase I trial.

• Protalex Inc., of New Hope, Pa., said the FDA removed the clinical hold on its investigational new drug application for PRTX-100, allowing the company to proceed with a Phase I trial in healthy volunteers. Protalex submitted the IND March 4, and the agency placed the application on hold pending additional product characterization. PRTX-100 is being evaluated in rheumatoid arthritis and other autoimmune diseases.

• Sangamo BioSciences Inc., of Richmond, Calif., released positive results from a preclinical animal efficacy study of zinc finger DNA-binding protein transcription factors for its program to develop a ZFP therapeutic for age-related wet macular degeneration. The study found that the ZFP transcription factors designed to regular key therapeutic gene targets identified for AMD reduce the amount of vessel growth in the eye compared to the control treatment. The approach could enable simultaneous regulation of both vascular endothelial growth factor and the pigment epithelium-derived growth factor in a single treatment that may provide more inhibition of a damaged blood vessel growth characteristic of AMD than current therapies that address a single target.

• Tanox Inc., of Houston, said an independent Data Safety Monitoring Board recommended continuing a Phase II study of TNX-355, an investigational HIV treatment, after reviewing the planned interim safety analysis. The board reported that no safety concerns were noted after 20 weeks of the 48-week study. The study is designed to compare the effect of two different dose schedules of TNX-355 added to optimized background therapy (OBT) vs. OBT plus placebo in 82 treatment-experienced HIV patients.

• VioQuest Pharmaceuticals Inc., of Monmouth Junction, N.J., said the Cleveland Clinic Taussig Cancer Center began enrolling patients in a Phase I trial of sodium stibogluconate (SSG), an oncology compound aimed at treating solid tumors, lymphoma and myeloma. The study's objectives are to determine the safety and tolerability of SSG, and to find the maximum tolerated dose when given in combination with interferon alpha-2b. SSG is expected to be acquired by VioQuest pending completion of its proposed purchase of New York-based Greenwich Therapeutics Inc. (See BioWorld Today, May 9, 2005.)

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