• Affibody AB, of Stockholm, Sweden, and Agilent Technologies Inc., of Palo Alto, Calif., formed an agreement to develop advanced protein sample preparation solutions for human biomarker discovery. Affibody will design and develop engineered Affibody ligands for specific protein targets designated by Agilent, which will use them to expand its line of proteomic sample preparation products. At the end of the development phase, Affibody will supply Agilent with production quantities of the materials. Also, Agilent, which announced last week the divestiture of its Semiconductor Products Group and the intent to spin off the System-on-a-Chip business, clarified that the sale involves purely electronic products and does not include Agilent's microarray-based "biochip" business. The company said it is still supporting the lab-on-a-chip platform and recently introduced the first commercial mouse genome, a CGH kit as part of its Comparative Genome Hybridization array. Subject to closing adjustments, the Semiconductor Products segment will go to Kohlberg Kravis Roberts & Co., of New York, and Silver Lake Partners, also of New York, for about $2.7 billion.

• Anadys Pharmaceuticals Inc., of San Diego, published results of a Phase Ib trial of isatoribine in patients with hepatitis C virus that showed a statistically significant reduction in viral load following seven days of treatment. Data were published in the recent issue of Hepatology. A prodrug form of isatoribine is being developed by Anadys and partner, Novartis AG, of Basel, Switzerland, to treat HCV.

• Arpida Ltd., of Basel, Switzerland, said the FDA granted fast-track status to intravenous iclaprim for the treatment of complicated skin and skin-structure infections, such as those caused by methicillin-resistant Staphylococcus aureus. Fast-track designation allows for an expedited review process for drugs intended to treat serious or life-threatening diseases.

• BioMS Medical Corp., of Edmonton, Alberta, received approval from the Swedish Medical Products Agency for its pivotal Phase II/III trial of MBP8298, a synthetic peptide for the treatment of secondary progressive multiple sclerosis. The trial is a double-blind, placebo-controlled study involving up to 553 patients.

• Callisto Pharmaceuticals Inc., of New York, completed its private placement of about 1.9 million shares of common stock at a price of 97 cents each to raise gross proceeds of about $1.8 million. Funds will go toward the company's ongoing research and development operations, including its lead cancer products, Altiprimod and Annamycin.

• Cel-Sci Corp., of Vienna, Va., received permission from the Canadian regulatory agency, Biologics and Genetic Therapies Directorate, to begin a global Phase III trial of its immunotherapy drug Multikine. Cel-Sci expects to enroll about 500 patients with head and neck cancer, which affects 500,000 people worldwide each year. A successful Phase III trial should enable Cel-Sci to apply for a Canadian license to market Multikine. Cel-Sci's stock (AMEX:CVM) rose 10 cents Tuesday, or 20.4 percent, to close at 59 cents.

• Cortex Pharmaceuticals Inc., of Irvine, Calif., said researchers from Wake Forest University Baptist Medical Center in Winston-Salem, N.C., demonstrated in a primate model that Ampakine CX71 improved cognitive performance and reversed the deleterious effects of sleep deprivation. Results were published in the Public Library of Science, Biology. The company said the research provided the basis for conducting its Phase II study in humans, which confirmed the drug's ability to improve wakefulness, memory, cognition and attention without causing systemic stimulation.

• EntreMed Inc., of Rockville, Md., said positive preclinical results for 2-methoxyestradiol in models of rheumatoid arthritis were presented during the 7th World Congress on Inflammation in Melbourne, Australia. The studies demonstrated that daily oral administration of 2ME2 resulted in a dose-dependent decrease in inflammation and tissue destruction. The company intends to file an investigational new drug application for 2ME2 in RA in 2006.

• Evolve Oncology Inc., of New York, appointed Paul Hopper CEO. Previously, he served as the CEO of Australian Cancer Technology, now Avantogen Ltd. He also previously served as managing director of Alpha Healthcare. Evolve Oncology develops drugs for cancer.

• Genaissance Pharmaceuticals Inc., of New Haven, Conn., will provide its high-throughput genotyping services to Biotronics Ltd., of Nicosia, Cyprus, which was awarded a contract to establish a breeding program in sheep that confers resistance to scrapie. The contract, awarded by the Veterinary Services in the Ministry of Agriculture, Natural Resources & Environment, is part of Cyprus' efforts to implement the European Union's mandate for such a breeding program. Biotronics will collect the tissue specimens and send them to Genaissance, which will analyze a minimum of 100,000 samples over three months.

• Generex Biotechnology Corp., of Toronto, said a paper published in the Journal of Immunotherapy reported a late preclinical step in validating a melanoma vaccine for clinical trials by describing how the insertion of a melanoma epitope into the Ii-Key/MCH Class II epitope hybrid peptide enhances T-cell responses in transgenic mice. Parallel peptides containing MHC Class II epitopes of the HER-2/neu antigen are in trials with breast cancer patients.

• Icoria Inc., of Research Triangle Park, N.C., signed an agreement with Carlsbad, Calif.-based Isis Pharmaceuticals Inc. to identify biomarkers of toxicity in animal models. Icoria will use its metabolomics platform to characterize differences in biochemical profiles between treated and untreated animal subjects and to identify those biochemicals that are specifically affected by treatment. Financial terms were not disclosed.

• Isolagen Inc., of Exton, Pa., is the subject of two securities lawsuits, both filed in a U.S. District Court on behalf of all persons who purchased publicly traded securities of Isolagen between March 3, 2004, and Aug. 1. The lawsuits allege Isolagen made false and misleading statements about its development of autologous cellular therapies and prospects for FDA approval that artificially inflated the price of its securities. Isolagen announced Aug. 1 that preliminary Phase III results of two studies of its proprietary process for contour deformities met three of four primary endpoints. On Aug. 1, the company's stock fell to $2.84 per share from a July 29 close of $5.59. The lawsuits follow CEO Robert Bitterman's resignation in late April.

• Kreatech Biotechnology BV, of Amsterdam, the Netherlands, launched the latest of its labeling kits for DNA microarray applications, the RNA ampULSe Amplification and Labeling Kit. The kit combines technology obtained from a supply agreement with Austin, Texas-based Ambion Inc. for its MessageAmp II aRNA amplification system with Kreatech's Universal Linkage system.

• Lorus Therapeutics Inc., of Toronto, has chosen two molecules, ML-133 and LT-253, as lead candidates for further development as cancer drugs. The decision was based on the results of preclinical studies. ML-133 and LT-253 are part of the ML-series, a group of low-molecular-weight compounds that show significant anti-proliferative activity against many human cancer cell lines.

• MediBIC Alliance, of Foster City, Calif., a subsidiary of MediBIC, and Daiichi Pharmaceutical Co. Ltd., of Tokyo, launched a venture capital investment fund targeting biotechnology ventures, mainly in the U.S. and Europe. The fund will invest in private, early stage firms, with a focus on a specific technology related to drug development.

• MIP Technologies AB, of Lund, Sweden, closed a financing round of $3.9 million. Catella Healthcare Investments AB took the major part of the round, with Malmohus Invest and company management also participating. MIP is a developer of molecularly imprinted polymers.

• Neurobiological Technologies Inc., of Emeryville, Calif., received a $10 million line of credit with Comerica Bank. NTI CEO Paul Freiman said the line of credit will provide additional working capital and that Phase III trials for Viprinex are expected to begin in several weeks and are under way for Xerecept, with the addition of new patient groups to accelerate enrollment. NTI focuses on therapies for neurological conditions.

• Nobex Corp., of Research Triangle Park, N.C., and Biocon Ltd., of Bangalore, India, signed a new agreement for global co-development of an oral brain-type natriuretic peptide product for the treatment of cardiovascular disease. The collaboration combines the delivery technology of Nobex with Biocon's peptide production capabilities to create a drug to treat heart failure and cardiovascular disorders. Financial terms were not disclosed.

• NPS Pharmaceuticals Inc., of Salt Lake City, filed a shelf registration statement with the SEC to offer and sell from time to time up to $200 million of common stock, preferred stock, depository shares, senior and subordinated debt securities, and warrants. NPS discovers, develops and commercializes small molecules and recombinant proteins as drugs, primarily to treat metabolic, bone and mineral, and central nervous system disorders.

• Oxigene Inc., of Waltham, Mass., reported the presentation of preclinical data supporting the development of OXi4503. Independent researchers presented results from ongoing studies that highlight the efficacy of OXi4503, a prodrug that can be activated to an ortho-quione compound, for the treatment of cancer.

• Pharmasset Inc., of Princeton, N.J., earned a milestone payment from partner Incyte Corp., of Wilmington, Del., as a result of Reverset exceeding the contractually defined goal of a 1.0 log10 reduction in HIV viral load in Study 203. The results indicate that 200 mg of Reverset given orally, once daily was potent, generally well tolerated and provided antiviral suppression in patients with a wide variety of HIV mutations. Incyte intends to meet with the FDA to propose Phase III studies of Reverset.

• Pharmaxis Ltd., of Sydney, Australia, is expected to list on Nasdaq under the symbol "PXSLY" by the end of the week. No new shares will be issued in conjunction with the listing, which is subject to approval by the SEC, and one American depository receipt will continue to equal 15 Pharmaxis ordinary shares. Pharmaxis develops pharmaceuticals to treat human respiratory and autoimmune diseases, including Aridol for asthma, Bronchitol for cystic fibrosis and chronic obstructive pulmonary disease, and PXS64 for multiple sclerosis.

• Profos AG, of Regensburg, Germany, raised €5 million (US$6.1 million) in the first closing of its recent financing round, with investments from Bio Fund Management, and two existing shareholders, Danisco Venture A/S and Capital Stage AG. Profos develops products for the capture and detection of bacteria and bacterial components based on phage-ligand technology.

• ProKinetix Inc., of Vancouver, British Columbia, completed its initial organ preservation trials using heart tissues. The tissue that was treated with its synthetically replicated antifreeze glycoprotein survived, in contrast to the untreated tissue that suffered 100 percent mortality. Those tests were conducted over a period of 8 hours at a temperature of 4 degrees Celsius.

• Symphogen A/S, of Copenhagen, Denmark, entered a patent license agreement with Cambridge Antibody Technology Group plc, of Cambridge, UK. Symphogen will receive a license to use CAT's antibody phage display patents for research purposes and to develop and commercialize a number of therapeutic and diagnostic antibody products. Upon signing, Symphogen made an up-front payment for the license and exercised its first option to develop and commercialize its lead product Sym001, which is being developed for idiopathic thrombocytopenic purpura and hemolytic disease of newborns. As a result, the company paid a product license fee, and may make future milestone and royalty payments to CAT.

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