• Abbott Laboratories, of Abbott Park, Ill., said positive preliminary data from two studies of Humira (adalimumab) in treating psoriatic arthritis and ankylosing spondylitis were reported at the European League Against Rheumatism annual meeting in Berlin. Specific findings showed that psoriatic arthritis patients responded to Humira as early as two weeks after the initial dose, showing significant improvement in the signs and symptoms of the joint disease and skin manifestations with continued improvements at 12 weeks. Analysis of a separate 12-week study showed that Humira significantly improves spinal symptoms in patients with active ankylosing spondylitis after one dose.

• Acacia Research Corp., of Newport Beach, Calif., said its CombiMatrix Group entered a co-marketing relationship with Axon Instruments Inc., of Union City, Calif., to jointly support sales of CombiMatrix's CustomArray microarray platform and Axon's GenePix scanners.

• Acceleron Pharma, of Cambridge, Mass., appointed Glenn Batchelder president and CEO and a board member. For the past five years, he was a senior executive at Millennium Pharmaceuticals Inc., also of Cambridge. Acceleron is developing drugs through approaches that exploit the therapeutic potential of a family of growth and differentiation factors.

• Aclara BioSciences Inc., of Mountain View, Calif., and the Tokyo Metropolitan Institute of Medical Science (Rinshoken) entered a collaboration to evaluate breast cancer patient samples to validate candidate biomarkers detected with Aclara's eTag technology. Aclara will provide research funding to Rinshoken and will have the ability to develop the biomarkers as clinical diagnostics. Rinshoken's newly established Translational Research Center will coordinate the project. Rinshoken will collect tumor samples and blinded patient data, including treatment histories and outcomes, and Aclara will evaluate the samples for responsiveness to certain targeted therapies, including Herceptin.

• Active Biotech AB, of Lund, Sweden, entered an agreement to develop and commercialize laquinimod, its immunomodulatory compound for multiple sclerosis, with Teva Pharmaceutical Industries Ltd., of Jerusalem. Teva will acquire exclusive rights to develop, register, manufacture and commercialize laquinimod worldwide, outside of Nordic and Baltic countries where Active Biotech will retain all commercial rights. In exchange, the agreement could be worth up to $92 million to Active Biotech, which will receive an up-front payment of $5 million and is eligible for milestone payments and tiered double-digit royalties. Teva will conduct and fund the further clinical development of laquinimod, for which Phase II data have shown that an oral formulation is well tolerated and effective in suppressing the development of active lesions in relapsing multiple sclerosis.

• Advanced Magnetics Inc., of Cambridge, Mass., presented data on the use of ferumoxytol-enhanced MRA to measure carotid artery disease at the 42nd American Society of Neuroradiology Annual Meeting in Seattle. Data showed that ferumoxytol provided positive delineation of the carotid arteries in patients and volunteers, concluding that ferumoxytol-enhanced MRA, compared with current methods, could improve the accuracy and precision of measurements of carotid artery disease. Ferumoxytol is in Phase II trials for use as a contrast agent in MRA, and Phase III studies in MRA are expected to begin next year.

• Angstrom Pharmaceuticals Inc., of San Diego, began a Phase II trial of its lead product, A6, to prevent clinical relapse in patients with ovarian cancer. The study will enroll 48 to 60 patients and is designed to assess the safety and efficacy of A6 in asymptomatic women in clinical remission who have an elevated CA-125 tumor-marker level following successful first-line treatment. A6 targets the urokinase plasminogen-activator system, which has been implicated in cancer progression.

• Array BioPharma Inc., of Boulder, Colo., began a Phase I trial of its small-molecule cancer compound, ARRY-142886, an ATP non-competitive inhibitor of the enzyme MEK 1/2. Array is entitled to a $4 million milestone payment for beginning the trial as part of its December agreement with AstraZeneca plc, of London. Array may receive additional development and commercialization milestones of more than $81 million and royalties on product sales. The trial will evaluate tolerability and pharmacokinetics following oral administration to patients with advanced cancer.

• Avanir Pharmaceuticals Inc., of San Diego, signed an exclusive agreement with the Gerolymatos Group of Companies, of Athens, Greece, to manufacture and market Avanir's docosanol 10 percent cream as a treatment for cold sores in Greece, Cyprus, Turkey and Romania. It is sold in the U.S. as Abreva by Avanir's licensee, GlaxoSmithKline plc, of London.

• Bioenvision Inc., of New York, said it would join the Russell 3000 Index when the broad-market index is reconstituted on June 25, according to a preliminary list of additions issued by Russell Investment Group. Also, the company said data related to clofarabine's use across a range of hematological malignancies were reported at the Congress of the European Hematology Association in Geneva.

• Bioniche Life Sciences Inc., of Belleville, Ontario, said data reported at the European League Against Rheumatism meeting in Berlin showed that the use of Suplasyn in treating osteoarthritis of the knee produced a significant reduction in pain and improved function levels as early as the third month, which were maintained at six months. Treatment with the sodium hyaluronate solution resulted in improved clinical outcomes at rest and in walking pain, high treatment satisfaction and a positive safety profile.

• Cell Therapeutics Inc., of Seattle, said preliminary Phase II findings reported at the Congress of the European Hematology Association in Geneva showed that single-agent Trisenox (arsenic trioxide) produced a defined hematologic response rate of 27 percent in myelodysplasia patients. The median duration of response was about four months. Data from another study showed that a combination of melphalan, Trisenox and vitamin C produced disease responses in seven of the 13 heavily pretreated multiple myeloma patients who had either relapsed or failed to respond to standard and/or investigational therapies.

• Cellumen, of Pittsburgh, was created to form discovery partnerships with pharmaceutical and biotechnology companies using high-content screening (HCS) with advanced, cell-based reagents and cell lines. The company was formed by the Pittsburgh Life Sciences Greenhouse and Lansing Taylor, a co-founder of Biological Detection Systems Inc. and Cellomics Inc. Cellumen, which will harness the HCS platform created by Cellomics to perform large-scale screens, will occupy 560 square feet of laboratory and office space at the PLSG Incubator facility and is expected to employ five to six people by the end of its first year.

• Centocor Inc., of Malvern, Pa., and Schering-Plough Corp., of Kenilworth, N.J., said findings reported at the European League Against Rheumatism meeting in Berlin showed that patients with active ankylosing spondylitis treated with Remicade (infliximab) achieved significant improvement in signs and symptoms. Specifically, more than 60 percent of Remicade patients demonstrated improvement in the ankylosing spondylitis assessment measure that includes spinal pain and function, compared to 19 percent of patients receiving placebo. The data stem from the ASSERT (Ankylosing Spondylitis Study for the Evaluation of Recombinant Infliximab Therapy) trial.

• Cytogen Corp., of Princeton, N.J., said it would likely join the Russell 3000 Index when the broad-market index is reconstituted June 25, according to a preliminary list of additions issued by Russell Investment Group.

• Dyax Corp., of Cambridge, Mass., and Genzyme Corp., also of Cambridge, said positive results from a Phase II trial of DX-88 to treat hereditary angioedema (HAE) showed the compound met its primary endpoint, significantly improving the symptoms of acute attacks of HAE within four hours of treatment. The safety profile of DX-88 was similar to placebo. DX-88, a kallikrein inhibitor discovered at Dyax being developed in a joint venture between Dyax and Genzyme, has orphan drug designation in the U.S. and Europe to treat HAE.

• Entropin Inc., of Indio, Calif., said a California superior court granted its motion for summary judgment in favor of the company, dismissing a class-action suit against the company as well as an officer and director who were included as defendants. The suit was filed in January 2003.

• Evotec OAI AG, of Hamburg, Germany, and Neuronova AG, of Munich, Germany, entered a drug discovery agreement to identify small-molecule compounds that interact with a Neuronova target involved in the treatment of depression and anxiety. Evotec will apply its capabilities in cell line construction, assay development and screening on a cellular target, and will provide profiling services to further characterize selected hits for progression.

The German Resource Center for Genome Research in Berlin said it is providing a service to compile protein-expression profiles by means of dedicated antibody chips. In addition to diagnostic applications, the organization said the chips can be used to identify proteins relevant to cell development, for toxicological studies and to determine the influence of environmental factors on a cell's protein-expression pattern.

• Geron Corp., of Menlo Park, Calif., said it presented results at the annual meeting of the International Society for Stem Cell Research in Boston, demonstrating significant progress in its development of cell therapies based on human embryonic stem cells (hESCs). Scientists demonstrated the differentiation of hESCs into islet-like cells similar to those found in the endocrine pancreas, which could lead to a treatment for Type I diabetes. There was no uncontrolled cell growth. The company also described two new hESC lines derived without exposure to mouse cells or mouse products.

• Hemispherx Biopharma Inc., of Philadelphia, submitted to the FDA a new clinical protocol for a multicenter, open-label study of Alferon N injection in people with relapsing-remitting multiple sclerosis who have discontinued interferon beta therapy because of clinical progression, intolerance or neutralizing antibody formation. The Phase IIb trial will include 50 patients and evaluate the safety and efficacy of the injection in patients who have discontinued treatment of Avonex, Rebif or Betaseron. The primary endpoint will be annualized clinical relapse rate at baseline compared to week 48.

• Integrated BioPharma Inc., of Hillside, N.J., appointed Orn Adalsteinsson president and CEO of its biotech subsidiary, NuCycle Therapy Inc. Previously he was the head of new business development at Arkion Life Sciences LLC. NuCycle is synthesizing human therapeutic proteins in plant-based production systems, including transient expression vectors based on plant viruses and transgenic plants.

• Interleukin Genetics Inc., of Waltham, Mass., and the Vanderbilt University Medical Center in Nashville, Tenn., entered a collaboration to determine the effectiveness of selected anti-inflammatory compounds on the prevention and treatment of endometriosis. Interleukin is focused on inflammation.

• Ligand Pharmaceuticals Inc., of San Diego, earned a $1 million milestone payment from GlaxoSmithKline plc, of London, as a result of GSK's decision to continue Phase II development of GW501516, a peroxisome proliferation-activated receptor (PPAR) modulator for the treatment of dyslipidemias. PPARs are a sub-family of intracellular receptors that regulate lipid and glucose homeostasis.

The Mayo Clinic in Rochester, Minn., said findings reported at the Congress of the European Hematology Association in Geneva showed that Zevalin (Yttrium-90 ibritumomab tiuxetan) therapy induced long-term, durable responses, some as long as 75 months, in relapsed or refractory patients with non-Hodgkin's lymphoma. Researchers from the University of California at Los Angeles said data from an integrated analysis of the radioimmunotherapy showed that non-Hodgkin's lymphoma patients who received second-line treatment demonstrated higher response rates and a longer duration of response, compared to patients receiving the therapy as a third-line intervention or later. Zevalin is marketed by Biogen Idec Inc., of Cambridge, Mass.

• Mutabilis, of Paris, secured €8 million in its second round of venture funding led by Auriga Partners. Other investors were Credit Lyonnais Private Equity, Bioam, Axa Private Equity and Inserm-Transfert. The capital provides the company with enough money to continue drug discovery activities until 2007. Founded in 2001, Mutabilis focuses on antibacterial agents. The company hopes to enter clinical trials toward the end of 2006.

• Palatin Technologies Inc., of Cranbury, N.J., said data on the activity of its lead series of melanocortin receptor, small-molecule agonists for obesity were presented at the 8th Annual American Neuroendocrine Society Neuroendocrine Workshop in New Orleans. Using its drug discovery platform technology, MIDAS (metal ion-induced distinctive array of structures), the company has identified a series of lead compounds that decrease food intake and body weight in normal and genetically obese animals.

• Perlegen Sciences Inc., of Mountain View, Calif., and the Mayo Clinic in Rochester, Minn., won a grant award from the Michael J. Fox Foundation for Parkinson's Research for their whole-genome association study of Parkinson's disease. Using Perlegen's high-throughput genotyping technology and expertise genetic variation in humans, combined with Mayo's DNA samples, the collaborators will assay the samples for the presence of single nucleotide polymorphisms associated with Parkinson's. Assuming all milestones are met, funding for the project would total about $2.8 million.

• Qiagen NV, of Venlo, the Netherlands, and Protedyne Corp., of Windsor, Conn., entered a collaboration to develop a fully automated, high-throughput sample-preparation system for molecular diagnostic customers. The collaboration is aimed at developing optimized ultra-high-throughput nucleic acid-purification procedures on Protedyne's BioCube Systems.

The Sidney Kimmel Cancer Center in San Diego said data published in the June 10, 2004, issue of Nature detailed its researchers' identification of biomarkers in solid-tumor blood vessels in rats that allowed them to use antibodies to direct radiation therapy to cancer cells without harming normal tissue.

• Spherics Inc., of Lincoln, R.I., began a Phase I trial of Spherazole (itraconazole), an oral formulation of the antifungal agent that incorporates Spherics' bioadhesive technology. The company's drug delivery approaches use bioadhesive technologies that release drugs at the preferred absorption site for an extended duration in the gastrointestinal tract, it said.

• Synthetic Blood International Inc., of Costa Mesa, Calif., said results of a Phase I study of Oxycyte, its perfluorocarbon blood substitute, are in line with previously reported preclinical safety studies. The company said it believes that Oxycyte might be useful in treating stroke, heart attack and cancer patients and for use as a blood substitute and in organ preservation.

• U.S. Oncology Inc., of Houston, said data reported at the American Society of Clinical Oncology meeting in New Orleans demonstrated that Abraxane (albumin nanoparticle paclitaxel), administered weekly without steroid premedication, was active and well tolerated in women with metastatic breast cancer whose disease had progressed while they were treated with paclitaxel and/or docetaxel. Specifically, results showed a 15 percent overall response rate in 106 patients who received Abraxane 100 mg/m2 administered weekly over 30 minutes a day without premedication for three weeks followed by one week of rest, with a 38 percent probability of surviving 12 months. Also, 40 percent were free of disease progression for as long as four months, and almost 30 percent for as long as six months.

• Valeant Pharmaceuticals Inc., of Costa Mesa, Calif., began the second of two global Phase III trials for its antiviral compound, Viramidine. Valeant is developing the product, a nucleoside (guanosine) analogue, in oral form to treat chronic hepatitis C in conjunction with a pegylated interferon. Valeant expects to complete enrollment of VISER2 next year. VISER1 began late last year and should complete enrollment this year. Both studies, which will be conducted at about 100 sites with about 1,000 patients in each, will compare Viramidine and ribavirin, each in conjunction with a pegylated interferon.

• Valentis Inc., of Burlingame, Calif., completed a private placement of about 2.2 million shares of common stock and warrants to purchase up to about 670,000 additional shares, raising $12 million in gross proceeds. The units were sold at about $5.41 each, and the five-year warrants are exercisable at $6.98 per share. The company issued and sold the stock and warrants to selected institutional and accredited investors, including current shareholders. Jefferies & Co. Inc. acted as exclusive financial adviser and sole placement agent. The company plans to use the funds for the manufacturing of Deltavasc, which is in Phase II for peripheral arterial disease. Funds also will go toward further Deltavasc clinical work and preclinical work in ischemic heart disease, as well as for other research and development and corporate purposes.

• Viragen Inc., of Plantation, Fla., said its stockholders approved the sale of $20 million in convertible promissory notes and common stock purchase warrants to eight institutional investors. Stockholders also approved a reverse stock split at a ratio of 1-for-10, and to change the number of shares that Viragen is authorized to issue. The funding is arranged by HPC Capital Management and will increase Viragen's cash position to about $25 million. The money will help the company progress the research, development and commercialization of its health care products and technologies.

• Xenova Group plc, of Slough, UK, said results of two Phase II studies of TA-CD, a vaccine for cocaine addiction, were reported at the College on Problems of Drug Dependence meeting in Puerto Rico. Results from both dose-escalation studies showed that the maximum mean antibody response occurred between 70 days and 90 days post-vaccination, with specific cocaine antibodies persisting for at least six months. Three-quarters of the relapse prevention study group maintained abstinence from cocaine use during the 12-week study duration, with 100 percent relapsing after 12 months, when antibody levels had dropped.

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