• A.P. Pharma Inc., of Redwood City, Calif., said Phase II results of APF112 being tested to treat pain following surgical inguinal hernia repair showed no significant difference between the drug and the standard of care (bupivacaine) in terms of pain scores, as well as amount of rescue pain medication used. However, the drug showed good safety and tolerability, and the company is evaluating the data to determine the next steps for the program. Phase I data on another product, APF530, for chemotherapy-induced nausea and vomiting, showed sustained blood levels over four days following administration. That drug was well tolerated with no unanticipated side effects. The company's stock (NASDAQ:APPA) dropped 57 percent, or $1.71 on Thursday, to close at $1.29.

• aaiPharma Inc., of Wilmington, N.C., is the subject of a lawsuit filed by CIMA Labs Inc., of Eden Prairie, Minn., for alleged fraud and breach of contract relating to the merger agreement entered into last year. CIMA paid a $11.5 million termination fee to aaiPharma in November in order to accept a superior offer from West Chester, Pa.-based Cephalon Inc. In March, aaiPharma said its board became aware of unusual sales in certain product lines and it later amended its financial information for 2002 and 2003. CIMA is seeking recovery of the $11.5 million termination fee, as well as fees and expenses in excess of $5 million related to the analysis and negotiation of the merger agreement with aaiPharma. (See BioWorld Today, Aug. 22, 2003.)

• Aeolus Pharmaceuticals Inc., of Research Triangle Park, N.C., said findings published in the Aug. 12, 2004, issue of Neuroscience Letters showed that its catalytic antioxidant, AEOL 10150, demonstrated sustained benefit in a mouse model of spinal cord compression injury. When administered intrathecally, AEOL 10150 resulted in improved function and an improved total damage score (based on histology measurements) compared to vehicle. The functional improvement was maintained over the 21-day observation interval. Methylprednisolone, administered intravenously as a control because it is commonly used for treating spinal cord injury in humans, had no effect in the model. The research, conducted at Duke University Medical Center in Durham, N.C., was supported by the Christopher Reeve Paralysis Foundation, the Paralyzed Veterans of America and the National Institutes of Health in Bethesda, Md.

• Ardais Corp., of Lexington, Mass., raised $4 million that it plans to use to accelerate the commercialization of its new information technology-based portfolio of biospecimen management solutions. The company added that the funding would allow it to reach cash flow breakeven. The financing included current investors Advanced Technology Ventures, Advent Health Care and Life Sciences, BioVentures Investors, EGS Healthcare Capital Partners, Federated Kaufmann Fund, Lancet Capital, Pequot Private Equity Fund and Silicon Valley Bancshares.

• Avigen Inc., of Alameda, Calif., said the FDA would allow it to begin a Phase I/II trial of AV201 for Parkinson's disease. The gene therapy product is designed to restore the therapeutic effectiveness of L-dopa by delivery of a human gene into the striatum of the brain that enables more efficient use of the drug.

• Chiral Quest Inc., of Monmouth Junction, N.J., changed its name to VioQuest Pharmaceuticals Inc. and created a wholly owned subsidiary in the process. The new business, VioQuest Drug Development Inc., will concentrate on acquiring, developing and commercializing human therapeutics. At the same time, the company will assign substantially all its operating and technology assets relating to its chemical catalysis platform to a second wholly owned subsidiary, which will be renamed Chiral Quest Inc. Additionally, Ronald Brandt was named president and CEO of the chiral catalyst business and will remain interim president and CEO of VioQuest.

• ChondroGene Ltd., of Toronto, said an article published in a recent supplement to the journal Circulation details the company's gene-expression profiling methods as part of its focus on genetic markers for detecting, staging and monitoring cardiovascular diseases and conditions.

• Commonwealth Biotechnologies Inc., of Richmond, Va., received new contracts for work in biodefense and clinical lab trial support. Under a $1.2 million contract, the company will develop novel reagents that can be used for detection of select agent pathogens. Under another contract, the company will conduct molecular assays on DNA extracted from samples taken from a two-year clinical trial.

• Discovery Laboratories Inc., of Doylestown, Pa., said the Commission of the European Communities designated Surfaxin an orphan medicinal product to prevent respiratory distress syndrome (RDS) in premature neonates of less than 32 weeks of gestational age and to treat it in premature neonates less than 37 weeks of gestational age. The company has filed a new drug application with the FDA for Surfaxin to prevent RDS in premature infants.

• GenData Research Corp., of Salt Lake City, entered a collaboration to discover, develop and commercialize biomarkers for diagnostic and therapeutic applications in chronic obstructive pulmonary disease with Battelle, of Columbus, Ohio. The agreement combines Battelle's technology with longitudinal clinical treatment data provided by GenData. The partners will analyze proteomic and metabonomic markers of patients diagnosed with the disease, as compared to well-characterized and matched controls, to identify biomarkers for diagnostic procedures, locate new molecular targets and pathways for therapeutic intervention and to discover clinical indicators for use in drug development. Financial terms were not disclosed.

• Geron Corp., of Menlo Park, Calif., said research published in this month's issue of Cancer Gene Therapy demonstrated the selectivity, efficacy and the lack of toxicity of an oncolytic virus containing the human telomerase promoter. In vitro assays showed that the virus killed multiple human cancer cell lines while having little effect on normal cells, including cultures of primary liver cells. The virus was significantly less toxic in normal liver cells than an earlier version that didn't contain the telomerase promoter. The work was conducted by scientists from Genetic Therapy Inc., an affiliate of Novartis AG, of Basel, Switzerland, and Cell Genesys Inc., of South San Francisco. Geron previously granted a nonexclusive license to Genetic Therapy to develop oncolytic viruses that employ the telomerase promoter, and Cell Genesys acquired Genetic Therapy's rights in its acquisition of the company's oncolytic virus assets.

• Guilford Pharmaceuticals Inc., of Baltimore, plans to launch two trials of Aggrastat injection (tirofiban hydrochloride) to determine the optimal therapeutic regimen for patients at the time of percutaneous coronary intervention. The company will conduct the first trial outside the U.S. as a double-blind, placebo-controlled study evaluating the 30-day efficacy of the single high-dose bolus regimen compared to placebo in high-risk patients undergoing PCI with coronary stent placement. It is expected to enroll about 2,000 patients in 100 centers. The second study will be a double-blind, randomized comparison of Aggrastat and ReoPro (abciximab). The company will enroll at least 8,000 patients in about 200 centers across the U.S.

• Illumina Inc., of San Diego, was awarded a $1.2 million Small Business Innovation Research grant from the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health in Bethesda, Md. The Phase II grant is for the continued development of high-multiplex, low-cost arrays to profile protein activity in small volumes of cells or biological fluids.

• Intercept Pharmaceuticals Inc., of New York, said findings published in Gastroenterology demonstrate that its lead FXR agonist, INT-747, can stop development of and, possibly, reverse liver fibrosis in animal models. Prior work by the company's founders and other researchers elucidated the role of FXR, a member of the nuclear hormone receptor family, in the regulation of bile flow and rate of bile synthesis from dietary cholesterol. Based on its latest results, Intercept plans to advance INT-747 into clinical trials early next year.

• Paradigm Genetics Inc., of Research Triangle Park, N.C., established an agreement in which its Paradigm Array Laboratories began offering services using the Laser Capture Microdissection systems and the Paradise Reagent System that belong to Arcturus Biosciences Inc., of Mountain View, Calif. Laser dissection of tissue samples allows researchers to target specific cell types for analysis. The companies said they already secured an unnamed pharmaceutical company as a customer for their combined services.

• Pharmos Corp., of Iselin, N.J., said the FDA granted orphan drug designation to its lead product candidate, dexanabinol, a neuroprotective agent in a pivotal Phase III trial for severe traumatic brain injury. The company said it expects to report results of the trial, which completed enrollment of 861 patients in March, around the end of this year.

• Prometheus Laboratories Inc., of San Diego, entered into a settlement agreement with Specialty Laboratories Inc., of Santa Monica, Calif., whereby Specialty has agreed not to use, offer or sell its 6-MP Drug MonitR assay for use in connection with the treatment of immune-mediated gastrointestinal disorders or autoimmune diseases. Prometheus will withdraw a patent-infringement lawsuit against Specialty Labs alleging that the use or sale of the product infringed certain Prometheus patent rights.

• Santarus Inc., of San Diego, said Zegerid would be the brand name for its immediate-release proton pump inhibitor products, replacing the formerly proposed Rapinex. The new name will apply to the recently approved 20-mg omeprazole powder for oral suspension. The FDA also has accepted for filing the company's new drug application for the 40-mg dose of the product. Santarus has initiated a pivotal trial of Zegerid capsules.

• Stanford University School of Medicine in Palo Alto, Calif., said its researchers published findings in the Aug. 12, 2004, issue of the New England Journal of Medicine describing their identification of a handful of leukemia cells that constantly replenish the supply of cancerous cells. They said the self-renewing cells, called cancer stem cells, must be eliminated by chemotherapy to eliminate the disease.

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