• Advanced Magnetics Inc., of Cambridge, Mass., and Cytogen Corp., of Princeton, N.J., said data from the Phase III trial of Combidex (ferumoxtran-10) in lymph nodes were published in the September issue of Radiology. The data showed that magnetic resonance imaging with Combidex, a superparamagnetic iron oxide nanoparticle, aids in the noninvasive evaluation of metastatic lymph nodes in patients with head and neck, chest, breast, abdominal and pelvic cancers. The study involved 147 patients with primary malignancies who were suspected of having nodal metastases. Overall, the data demonstrated that Combidex-enhanced MR imaging improved diagnostic accuracy from 68 percent to 85 percent.

• Affymetrix Inc., of Santa Clara, Calif., released its GeneChip-brand CustomExpress 11-micron array format, which it said can measure up to 61,000 transcripts. The CustomExpress array's reduced size accommodates nearly three times more information than its predecessor, Affymetrix said.

• AlphaRx Inc., of Richmond Hill, Ontario, entered an agreement with Industria Farmaceutica Andromaco SA de C.V., of Mexico City, which will manufacture, sell, market and distribute Indoflex throughout Mexico. Andromaco guaranteed escalating sales income to AlphaRx throughout the five-year contract. Indoflex is a topical version of the nonsteroidal anti-inflammatory drug indomethacin. Financial terms were not disclosed.

• Amersham Biosciences, of Piscataway, N.J., the life sciences business of Amersham plc, of London, reported that Isis Pharmaceuticals Inc., of Carlsbad, Calif., completed what it called the world's largest antisense oligonucleotide synthesis scale per single run. Isis accomplished that by using OligoProcess from Amersham Biosciences, combined with its synthesis methods and custom reactor column. Separately, Amersham Biosciences reported the addition of CodeLink UniSet Mouse 20K I Bioarray to its CodeLink Expression range. The high-density bioarray is designed to enable scientists to study gene expression across much of the mouse genome.

The Amgen Foundation, of Thousand Oaks, Calif., gave $8 million in grants to nonprofit organizations nationwide in 2002. The foundation, created in 1991, focuses on three areas: health and medicine, science education and the community. The foundation has developed two signature programs, including a $3 million gift for the Amgen Center for Science Learning at the California Science Center in Los Angeles.

• Antisense Pharma GmbH, of Regensburg, Germany, said it obtained positive results from a Phase I/II trial of AP 12009 in high-grade glioma. The company said it combines precise selection of cancer target molecules and DNA-based phosphorothioate oligonucleotides.

• ArQule Inc., of Woburn, Mass., entered a chemistry collaboration with Novartis Institutes for BioMedical Research Inc., an affiliate of Novartis AG, of Basel, Switzerland. ArQule will apply its integrated chemistry technology platform to generate and optimize small-molecule compounds for Novartis' anti-infective drug discovery program. Financial terms were not disclosed.

• AVI BioPharma Inc., of Portland, Ore., said a preclinical study conducted at the Scripps Research Institute in La Jolla, Calif., pointed to the antiviral activity of AVI-4179 against the human coronavirus implicated in severe acute respiratory syndrome. Treatment with the Neugene antisense compound protected infected cells from viral-induced cell death, limited the growth of the virus and reduced the spread of the virus in cell culture. AVI said it continues to collaborate with several U.S. and international laboratories, including the National Institute of Allergy and Infectious Diseases, a division of the National Institutes of Health in Bethesda, Md.

• BioMarin Pharmaceutical Inc., of Novato, Calif., reported data at this week's International Congress of Inborn Errors of Metabolism in Brisbane, Australia, showing that intrathecal injection of recombinant human alpha-L-iduronidase (rhIDU) can reduce carbohydrate storage in brain tissue in the canine model of MPS-I (mucopolysaccharidosis-I). More specifically, once-weekly dosing for four weeks delivered high levels of enzyme to the brain leading to normalization of glycosaminoglycan (GAG) carbohydrate levels in all four MPS-I dogs treated. Also, the penetration and activity of rhIDU in canine brain tissue was dose dependent and the enzyme also penetrated the scarred and thickened meninges in MPS-I dogs, resulting in substantial reductions in GAG storage. GAG storage in the meninges can lead to spinal cord compression, a debilitating symptom of MPS-I.

• Biosyn Inc., of Huntingdon Valley, Pa., said that enrollment was initiated in a Phase I trial of UC-781 as a microbicide for the prevention of sexually transmitted HIV. UC-781 is a non-nucleoside reverse transcriptase inhibitor that has shown in vitro to be very active specifically against HIV-1. The first trial is a single-center, placebo-controlled, closed-label, randomized study to evaluate the safety and acceptability of daily intravaginal dosing of the product among 48 healthy, sexually abstinent women.

• Boston Life Sciences Inc., of Boston, reported that scientists at Boston Children's Hospital and BLS identified specific carbohydrates capable of stimulating optic nerve regeneration. The discovery also provides an explanation as to why fish and amphibia retain the ability to regenerate their optic nerves after injury, and why mammals (including humans) have lost that ability. The findings are published in the current issue of the Journal of Neuroscience, and are the subject of a featured review in the journal. The company's stock (NASDAQ:BLSI) gained 29 cents Thursday, or 19.9 percent, to close at $1.75.

• Cambrex Corp., of East Rutherford, N.J., entered an agreement with Analytical Bio-Chemistry Laboratories Inc., of Columbia, Mo. The arrangement is intended to provide Cambrex's pharmaceutical customers with extended services through access to ABC's development and analytical offerings, such as radiolabeled drug candidates for binding studies, ADMET studies and bioequivalency, stability and other testing services required for FDA drug registration. Financial terms were not disclosed.

• Computer Sciences Corp., of El Segundo, Calif., said that DynPort Vaccine Co. LLC, a joint venture between CSC and Porton International Inc., of London, was awarded an $11 million grant from the National Institute of Allergy and Infectious Diseases, a part of the National Institutes of Health in Bethesda, Md. DVC plans to develop the manufacturing processes for safe and efficacious vaccines that will protect against all known forms of botulinum neurotoxins within five years.

• Corimbia Inc., of Berkeley, Calif., said that Children's National Medical Center, a leading children's research center in muscular degenerative diseases, selected its gene expression quality assessment software platform, Probe Profiler, to automatically generate expression values using multiple statistical approaches. Probe Profiler is expected to allow CNMC to automate and optimize its data analysis using methodology specific to biological conditions. That improves biological relevance of the results and increases efficiency and consistency in the data analysis pipeline, the company said.

• CuraGen Corp., of New Haven, Conn., said data published in this month's issue of the Journal of the American Society of Nephrology demonstrated the activity of CR002, its fully human preclinical antibody, in an animal model of nephritis, or kidney inflammation. More specifically, CR002 was shown to reduce mesangial cell proliferation in an anti-Thy 1.1 nephritis animal model. The research was conducted by CuraGen and colleagues from Abgenix Inc., of Fremont, Calif., and the University of Aachen in Germany. CuraGen has the rights to develop CR002 through a collaboration with Abgenix.

• Dendreon Corp., of Seattle, said the FDA designated its investigational immunotherapy Provenge as a fast-track development program for the treatment of asymptomatic, metastatic, androgen-independent prostate cancer. Provenge is in a pivotal, double-blind, placebo-controlled Phase III trial seeking to confirm previous results that indicate the product may delay progression of the disease. Dendreon's stock (NASDAQ:DNDN) rose $2.30 Thursday, or 36.9 percent, to close at $8.53.

• Depomed Inc., of Menlo Park, Calif., reported interim Phase III data at this week's Thomas Weisel Partners Healthcare Tailwinds conference in Boston, showing that its once-daily Ciprofloxacin GR product is as effective as Cipro (ciprofloxacin, from Bayer AG). Findings from the study, which has enrolled about two-thirds of the planned 760 patients since beginning earlier this summer, showed both treatments comparably eradicated the organisms responsible for uncomplicated urinary tract infections. The trial, which is designed to show the noninferiority of Depomed's once-daily oral antimicrobial compared to twice-daily, immediate-release Cipro, is expected to be completed in the first quarter of next year. The analysis was conducted on still-blinded data to date. (See BioWorld Today, June 4, 2003.)

• Elan Corporation plc, of Dublin, Ireland, said it concluded its 2002 audit and plans to file by today its annual report on Form 20-F for the fiscal year ended Dec. 31. The company said the action would cure previously reported defaults under certain of its outstanding debt.

• Genzyme Corp., of Cambridge, Mass., filed for Japanese approval to market Synvisc (hylan G-F 20) for the treatment of pain from osteoarthritis. Synvisc is approved in the U.S., Europe and 60 other countries. Genzyme said the product, which it expects to generate worldwide sales from $262 million to $284 million this year, would compete in a Japanese market valued at about $300 million.

• Hemispherx Biopharma Inc., of Philadelphia, said it signed an agreement with Guangdong Medicine Group Corp. in China to organize clinical trials, marketing, sales and distribution for both of its lead compounds, Alferon and Ampligen in China. The agreement stipulates that the Guangdong Medicine Group will conduct clinical trials with Alferon N injection, a natural-source, multispecies alpha-interferon product, for the treatment of hepatitis C, and with Ampligen, a double-stranded RNA compound for the treatment of HIV. Financial terms were not disclosed.

• Inpharmatica Ltd., of London, entered a two-year agreement with British Biotech plc, of Oxford, UK, for the provision of ADME services in connection with its drug discovery activities. Inpharmatica's ADME team will provide assays, analysis and interpretation of ADME data for a number of different project teams at British Biotech. Financial terms of the transaction were not disclosed.

• IsoTis SA, of Lausanne, Switzerland, said that as part of its merger with GenSci OrthoBiologics, the main subsidiary of GenSci Regeneration Sciences Inc., of Irvine, Calif., it would reduce its work force by about 29 percent. The move, which would lower its headcount to 60 employees from 85, is part of IsoTis' plans to streamline operations to focus on orthobiologics. As a result, the company said it intends to discontinue or spin off all its cell biology programs, putting on hold the development of VivesCart, a long-term tissue-engineered cartilage development program; transferring employees from its skin programs to a wound management subsidiary; spinning off its basic research group; and further streamlining the overall business. The companies reported their merger plans earlier this summer. (See BioWorld Today, June 4, 2003.)

The Lupus Research Institute in New York is seeking applications for new grants, with particular attention to development of biomarkers to assess disease activity in lupus and possible response to therapy. Novel Research Grant recipients receive $225,000 over three years. Information and applications are available at www.lupusresearchinstitute.org.

• Neurocrine Biosciences Inc., of San Diego, could raise $160.2 million after reporting plans to publicly offer 3 million common shares pursuant to an effective shelf registration statement previously filed with the SEC. The figure is based on the $53.39 closing price of the shares on Wednesday, the day before Neurocrine announced the sale. The company, which is selling all the shares, plans to grant the underwriters a 450,000-share overallotment option. Morgan Stanley and Merrill Lynch & Co. are the offering's joint book-running managers, while co-managers include Deutsche Bank Securities; UBS Investment Bank; Bear, Stearns & Co. Inc.; CIBC World Markets Corp.; Bank of America Securities LLC; and Credit Suisse First Boston.

• Orchid BioSciences Inc., of Princeton, N.J., said its European Cellmark business was selected by London's Metropolitan Police Service to provide scene-of-crime forensic DNA testing services. The three-year contract, extendable for an additional two years, was awarded through Orchid partner Forensic Alliance and is expected to generate the equivalent of several million U.S. dollars annually in revenue for Orchid, it said.

• Pharmacyclics Inc., of Sunnyvale, Calif., opened two new Phase I trials of its investigational drug Xcytrin (motexafin gadolinium) injection in combination with Taxotere for the treatment of advanced solid tumors. The trials each will recruit about 25 patients with relapsed prostate, breast, lung or ovarian cancers that have failed initial chemotherapy. Each of the protocols is designed to evaluate Xcytrin in combination with different, but commonly used, Taxotere dosing regimens.

• Prana Biotechnology Ltd., of Melbourne, Australia, said it is raising $A5 million (US$3.2 million) through an agreement for the private placement of up to 7.15 million shares at A70 cents per share. Funds will be used for advancing the company's suite of metal protein attenuating compounds and other purposes. Last month the company said it selected a new chemical entity named PBT-2 to advance to human trials for Alzheimer's disease.

• Strategic Diagnostics Inc., of Newark, Del., said its board named Matthew Knight president and CEO and also appointed him to the board. Prior to joining SDI, Knight spent 23 years at Nalco Chemical Co. Strategic Diagnostics is a provider of antibody products and analytical test kits for the food safety and water quality markets.

• TGN Biotech Inc., of St-Tite-des-Caps, Quebec, acquired more than 200 hectares of land on which it plans to build in the next year a swine production unit in order to manufacture recombinant proteins. The company, which acquired the site with a portion of the proceeds from a recently closed, second round of financing worth more than C$5 million (US$3.6 million), was founded on its Semenesis technology that uses the porcine seminal gland as a bioreactor to produce recombinant proteins as active drug ingredients.

• Transkaryotic Therapies Inc., of Cambridge, Mass., reported long-term data from a Phase I/II trial at this week's International Congress of Inborn Errors of Metabolism in Brisbane, Australia, demonstrating the ability of iduronate-2-sulfatase (I2S) enzyme replacement therapy in treating Hunter syndrome, also referred to as MPS-II. The one-year data showed improvements in a variety of clinical measures, including a greater improvement in joint range of motion and with the six-minute walk test, and continued to demonstrate a favorable safety profile. Six-month data showed a significant reduction in urinary glycosaminglycan excretion, significant reductions in liver and spleen volumes, as well as reductions in left ventricular mass and improvements in forced vital capacity. Patients receiving placebo who crossed over to I2S also showed a similar treatment response. Additional data will be presented at November's American Society of Human Genetics meeting. Later this month, the company plans to begin a 90-patient pivotal study to determine safety and efficacy of I2S as a treatment for Hunter syndrome.

• Unigene Laboratories Inc., of Fairfield, N.J., said its new drug application covering injectable and nasal calcitonin products for osteoporosis was filed in China. Contingent upon receipt of approval and an official business license from Chinese authorities, Unigene expects that the products will be distributed under the terms of its joint venture agreement with the Shijiazhuang Pharmaceutical Group, one of the largest pharmaceutical companies in China.

• VaxGen Inc., of Brisbane, Calif., and the Health Protection Agency (HPA) for England and Wales in Porton Down, UK, signed a binding letter of intent to negotiate terms under which VaxGen would license UK rights to, and transfer technology for, its recombinant anthrax vaccine candidate to HPA. The agreement would give HPA the right to manufacture the vaccine in the UK as well as to market the vaccine in the UK and possibly other territories. VaxGen's stock (NASDAQ;VXGN) rose $1.04Thursday, or 22.4 percent, to close at $5.70.

• Vicuron Pharmaceuticals Inc., of King of Prussia, Pa., achieved a milestone in its ongoing research collaboration with Novartis Pharma AG, of Basel, Switzerland, focused on the development of peptide deformylase inhibitor antibiotics. The achievement triggers an undisclosed milestone payment to Vicuron. Peptide deformylase inhibitors constitute a promising new antibiotic class to treat a spectrum of community-acquired bacterial infections, such as those of the respiratory tract, the company said.

• Viragen Inc., of Plantation, Fla., said positive results from in vitro studies conducted by the Genome Institute of Singapore point to the use of Multiferon for severe acute respiratory syndrome. More specifically, Viragen said preliminary studies demonstrated an antiviral response when Multiferon was added to SARS-infected cells, as measured by determinations of the change in the cytopathic effect and in the reduction of viral plaques. Viragen's stock (AMEX:VRA) gained 5 cents Thursday, or 19.2 percent, to close at 31 cents.

• VIRxSYS Corp., of Gaithersburg, Md., said an independent data safety monitoring board unanimously recommended continuing a Phase I trial involving HIV-positive patients receiving autologous VRX496-modified T cells, after reviewing initial safety data from its first patient. VIRxSYS said the study is the first to use lentiviral vectors in humans. The therapy is designed to place the disease into permanent remission by creating an army of VRX496-containing CD4 T cells in a patient's body that permanently suppresses HIV infection and reconstitute the immune system to prevent the onset of symptomatic AIDS.

• Wilex AG, of Munich, Germany, and the Fox Chase Cancer Center in Philadelphia were awarded the first Biotechnology Clinical Partnership Award, worth $3.9 million, from the U.S. Defense Department's Breast Cancer Research Program. The award will support the development of Wilex's WX-UK1 for the antimetastatic treatment of advanced breast cancer patients at Fox Chase.

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