• Aastrom Biosciences Inc., of Ann Arbor, Mich., initiated a Phase I trial in collaboration with investigators at Duke University Medical Center in Durham, N.C. The trial will evaluate a dendritic cell-based vaccine as a new treatment for an assortment of gastrointestinal system cancers, including colorectal, stomach and pancreatic cancers. The trial protocol will examine the safety, feasibility, immune outcome and clinical efficacy of a vaccination that is produced by loading tumor-associated peptide antigens onto a patient's blood-derived dendritic cells. The vaccine is produced using Aastrom's DCV-II dendritic cell vaccine production kit and the AastromReplicell System.

• Aerogen Inc., of Mountain View, Calif., completed its first Phase II trial evaluating delivery of aerosolized amikacin for the treatment of ventilator associated pneumonia. The data were submitted to be presented at the American Thoracic Society Conference in Orlando, Fla., in May. The efficiency of delivery of aerosolized amikacin to the lungs of ventilated patients was determined using a new nebulizer under development at Aerogen. Two commercially available nebulizers were tested as comparators. Aerogen's new nebulizer was optimized with respect to aerosol particle size and aerosol administration time during the inspiratory phase of the ventilator cycle and was found to be the most efficient among the nebulizers tested in delivery of drug to the lung.

• Alnylam Pharmaceuticals Inc., of Cambridge, Mass., launched the InterfeRx licensing program, through which it will grant licenses for the development of RNA interference therapeutics under the company's portfolio of issued and pending patent rights relating to small interfering RNA (siRNA) molecules and their use as drugs. Licenses will be made available on a target-by-target basis.

• BioTime Inc., of Berkeley, Calif., commenced its rights offer under which it will distribute subscription rights to the holders of common shares, entitling each holder to subscribe for and purchase one unit for every eight rights held. Each unit will consist of one new common share and one-half of a warrant to purchase an additional common share. The price is $1.40 per unit, and each full warrant will entitle the holder to purchase one share for $2, expiring Jan. 14, 2007. The rights offer will expire at 5 p.m. EST on Dec. 31. BioTime shareholders will get one right for each common share held as of the close of business on Dec. 10, which has been set as the record date for determining shareholders entitled to receive rights. BioTime's stock (AMEX:BTX) closed Wednesday, the day before the rights offer was disclosed, at $1.48. Shares ended Thursday at $1.45, down 3 cents.

• Chiron Corp., of Emeryville, Calif., and Gen-Probe Inc., of San Diego, said clinical trials of the Procleix Ultrio Assay for the simultaneous detection of HIV-1, hepatitis C virus and hepatitis B virus in donated blood, plasma, organs and tissue, have started in the U.S. The companies developed the Procleix Ultrio Assay via a collaboration. Chiron will distribute and market the test.

• Cyanotech Corp., of Kailua Kona, Hawaii, said the holder of a $1.25 million principal amount convertible debenture has voluntarily converted the debt to about 1.9 million shares of the company's common stock. In addition to reducing overall debt and increasing the company's net equity, the conversion will decrease future quarterly interest expense by $31,000, the company said. Cyanotech produces natural products from microalgae and is the world's largest commercial producer of natural astaxanthin, an antioxidant, from microalgae.

• Cypress Bioscience Inc., of San Diego, released data from its Phase II fibromyalgia syndrome study demonstrating that treatment with milnacipran was equally effective in reducing pain for both depressed and nondepressed patients. However, the company said, the response rate in patients treated with placebo was considerably lower in nondepressed patients than in those who met criteria for major depression on entering the trial. Milnacipran is a dual-acting agent that acts on two key neurotransmitters, norepinephrine and serotonin, which are involved with the central modulation and processing of chronic pain. The candidate currently is the subject of a Phase III program in fibromyalgia.

• DeCode Genetics Inc., of Reykjavik, Iceland, isolated two genes as part of its alliance with Merck & Co. Inc., of Whitehouse Station, N.J., to develop drugs for obesity. The genes were identified through population and genome-wide linkage scans and association with analyses of at-risk haplotypes using genetic and clinical data from the 17,000 participants in DeCode's obesity program in Iceland. The companies now are analyzing the genes and the biological pathways they delineate to select optimal targets for the development of new drugs.

• Genaissance Pharmaceuticals Inc., of New Haven, Conn., entered an agreement to provide certain pharmacogenomic services and technology to Ferring Pharmaceuticals A/S, of Copenhagen, Denmark. More specifically, Genaissance will provide its GLP-compliant DNA banking services through its operations in Morrisville, N.C., and also will collaborate with Ferring to identify clinical projects for the application of Genaissance's HAP technology. Financial terms were not disclosed.

• GMP Immunotherapeutics Inc., a subsidiary of GMP Companies Inc., of Fort Lauderdale, Fla., exclusively licensed worldwide rights to a new class of molecules designed to treat systemic lupus erythematosus, rheumatoid arthritis, psoriasis and some forms of cancer from the University of Michigan in Ann Arbor, with which it also entered a sponsored research agreement. The technology, developed at the university, involves the application of benzodiazepine derivatives against a new molecular target. Over the next several years, GMP will provide the university research funding, license fees, research milestone payments and royalties, based on the success of the drug candidates.

• ID Biomedical Corp., of Vancouver, British Columbia, said it has data demonstrating protection against variant strains of influenza. Nasal immunization with the subunit Proteosome-A/Texas vaccine protected 100 percent of the mice against mortality and weight loss, following exposure to the live A/Taiwan drift variant virus. The same challenge dose of live A/Taiwan virus caused 100 percent mortality in nonvaccinated control animals. Only the nasal Proteosome-HA subunit vaccine induced detectable mucosal IgA in the respiratory tract, which might explain the enhanced cross-protection shown by the mucosally-delivered Proteosome-subunit influenza vaccine. FluINsure, ID Biomedical's nasal Proteosome-influenza subunit vaccine, is being tested in a 1,345-subject field efficacy study.

• Ikonisys Inc., of New Haven, Conn., said a group of private investors led by Saint Simeon Marketing e Investimentos Lda., of Madeira, Portugal, bought $3.5 million in Series C preferred shares at a price of $1 per share. Proceeds from the financing will fund the company's various product development programs and ongoing operations. Privately held Ikonisys is focused on cell-based diagnostic products for the obstetrical and oncology markets.

• Introgen Therapeutics Inc., of Austin, Texas, and collaborators at the University of Texas M.D. Anderson Cancer Center in Houston reported preclinical data at this week's International Conference on Gene Therapy of Cancer in San Diego, further defining the mechanisms of action by which mda-7/IL-24, the active component of INGN 241, regulates the migration and death of lung cancer cells. More specifically, in addition to killing cancer cells, INGN 241 also blocks their migration and, therefore, their ability to metastasize. Other mechanisms by which mda-7/IL-24 gene expression fights cancer include stimulation of immune cells, induction of apoptosis and inhibition of angiogenesis. Separate preclinical findings showed that human cancer cells were sensitive to the antitumor effects of INGN 241, whereas normal ovarian cells were not affected by mda-7/IL-24 (also called Ad-mda-7).

• Lipid Sciences Inc., of Pleasanton, Calif., plans to expand its development program for its HDL Therapy platform. Lipid Sciences intends to develop the HDL Therapy platform along a parallel path with its Viral Immunotherapy platform, which is focused on the removal of lipid coatings from viruses and other lipid-containing infectious agents. The HDL Therapy platform is aimed at developing potential treatments for the reversal of atherosclerosis. Technology for the platform is based on a patented process that removes lipids from lipoproteins, such as HDL, without harming the proteins that carry the lipid particles.

• Medarex Inc., of Princeton, N.J., said its licensing partner, Centocor Inc., a wholly owned subsidiary of Johnson & Johnson, of New Brunswick, N.J., began a multidose Phase I trial of CNTO 95, a fully human antibody targeting the integrin receptors implicated in tumor-induced angiogenesis. Preclinical data presented by Centocor at the 94th annual meeting in July of the American Association for Cancer Research indicated that blockage of the integrin receptors by CNTO 95 inhibited the growth of new blood vessels in vitro and also inhibited growth of human melanoma tumors in nude mice. CNTO 95 was generated at Centocor using Medarex's UltiMAb technology.

• Medisyn Technologies Inc., of Minneapolis, completed a $1.5 million bridge financing. Current investor Sherpa Partners led the round that included new venture capital and angel investors. Proceeds will be used to further the testing of lead drug candidates and fund the completion of pilot projects already under way with pharmaceutical partners. Medisyn Technologies is a drug design and assessment company focused initially on treating cancer.

• Millennium Pharmaceuticals Inc., of Cambridge, Mass., and collaborators at Weill Cornell Medical College in New York published findings in the Dec. 11, 2003, edition of Science pointing to the identification of seven genes essential for the survival of the tuberculosis bacteria, Mycobacterium tuberculosis (Mtb), including several associated with the bacterial proteasome. The research could advance the understanding of how tuberculosis might be able to live in a patient's body, surviving continuous attacks from the immune system. Other findings published by researchers at Millennium and Walter Reed Army Institute of Research in the same day's edition of Neurotoxicity Research provided data supporting the involvement of the ubiquitin-proteasome pathway in inflammation within the brain following stroke. They found that in an animal model of cerebral ischemia, treatment with a proteasome inhibitor reduced NF-kB activation, lessening inflammation and neuronal damage within the brain.

• Peregrine Pharmaceuticals Inc., of Tustin, Calif., entered an agreement to humanize one of its vascular targeting agent (VTA) antibodies with Aeres Biomedical Ltd., of London. Peregrine will provide the murine VTA antibody to Aeres, which will use its humanization technology to provide a humanized VTA clinical candidate. Financial terms were not disclosed. Peregrine's stock (NASDAQ:PPHM) gained 29 cents Thursday, or 13.2 percent, to close at $2.49.

• Pharmacyclics Inc., of Sunnyvale, Calif., released two abstracts describing its lead drug, Xcytrin, and a third abstract on studies evaluating the activity of a novel potential cancer compound in hematologic tumors. The abstracts were reported at the 45th annual meeting of the American Society of Hematology in San Diego. In the Xcytrin (motexafin gadolinium) abstracts, Pharmacyclics described studies analyzing the candidate's ability to induce apoptosis in cultured lymphoma, leukemia and myeloma cancer cells. Separately, Pharmacyclics said it started a Phase II trial of Xcytrin as a single agent for the treatment of relapsed chronic lymphocytic leukemia.

• PPD Inc., of Wilmington, N.C., provided full-year 2004 earnings-per-diluted-share guidance of $1.65 to $1.72, reflecting a dilution of 19 cents to 20 cents from the discovery segment, which includes costs and expenses associated with activities under its partnering arrangements. Net revenue for next year, excluding out-of-pocket reimbursement, is expected to range from $760 to $770 million, an increase of 14 percent to 15 percent over this year's forecast.

• Protein Design Labs Inc., of Fremont, Calif., initiated a Phase I/II trial of visilizumab (Nuvion) in patients with severe ulcerative colitis whose disease has not responded to treatment with intravenous steroids. In the open-label trial, PDL will enroll up to 12 patients for each of four cohorts for the dose-finding stage of the study. Following that, the company expects to add 20 more patients for the Phase II portion. The clinical trial will enroll patients with Epstein-Barr virus levels up to 5,000 copies/ml and has a provision for re-treatment of patients who have an initial response to visilizumab, and develop an exacerbation of symptoms during the follow-up period.

• Rigel Pharmaceuticals Inc., of South San Francisco, reported positive clinical safety data for R112, an experimental drug to treat allergic rhinitis. The multidose trial results indicate that R112 is well tolerated and demonstrated a favorable safety profile in the study population. Three different dose regimens were studied in groups of six volunteers each and compared with placebo controls over a 10-day treatment period. Rigel said it plans to initiate Phase II efficacy trials in early 2004.

• Salix Pharmaceuticals Ltd., of Raleigh, N.C., said the FDA permitted clinical trials to initiate under the company's recently filed investigational new drug application for granulated mesalamine. The company intends to initiate preliminary dose-characterization trials within the next several weeks and to initiate two Phase III studies by the end of the first half of 2004. Salix plans to develop granulated mesalamine, a prolonged-release formulation of mesalamine, as a treatment for ulcerative colitis.

• Senesco Technologies Inc., of New Brunswick, N.J., said it demonstrated that the inhibition of its gene, Eukaryotic Translation Initiation Factor 5A1, can significantly reduce apoptosis caused by tumor necrosis factor alpha (TNF-alpha). TNF-alpha is a pro-inflammatory cytokine that mediates the response of the immune system to infection and trauma, and is known to activate apoptosis as well as cause inflammation. Senesco performed tests on lamina cribrosa cells from the human optic nerve head and on an epithelial cell line from the human intestine using a newly synthesized, highly specific factor of Factor 5A1 function.

• Structural GenomiX Inc., of San Diego, achieved a milestone in its collaboration with the Cystic Fibrosis Foundation Therapeutics Inc., of the Cystic Fibrosis Foundation, of Bethesda, Md., in relation to the murine cystic fibrosis transmembrane conductance regulator (CFTR). Structural GenomiX determined the first 3-dimensional crystal structure of the nucleotide-binding domain 1 of the murine CFTR. The findings will be published in the Dec. 18, 2003, advanced online publication of the EMBO Journal. CFTR is the protein that, when mutated, causes cystic fibrosis.

• Targent Inc., of Princeton, N.J., said it acquired a cancer compound called dibromodulcitol from Feminique Corp., of Bellport, N.Y. An oral cytotoxic drug, Targent said it has been studied in patients with a range of cancers including brain, breast and cervical malignancies, and has shown the ability to cross the blood-brain barrier and could be effective in a variety of malignancies that originate or metastasize to the central nervous system. Financial terms were not disclosed.

• Theratechnologies Inc., of Montreal, completed enrollment for its Phase II trial in HIV-related lipodystrophy using ThGRF. The trial, which aims to assess the safety and efficacy of ThGRF in reducing abdominal adiposity, began in May and the results are expected at the end of the first quarter in 2004. The double-blind, placebo-controlled study is expected to enroll up to 60 patients.

• VaxGen Inc., of Brisbane, Calif., completed the sale of 4.1 million shares of its common stock at $7 per share through a registered direct offering. The transaction raised gross proceeds of $28.7 million and net proceeds of about $27 million. Acting as placement agents were CIBC World Markets Corp., of New York; Punk, Ziegel & Co., of New York; and Enable Capital LLC, of San Francisco. The company said proceeds would be used to advance its smallpox vaccine program and conduct any expansions the company might decide upon, as well as for general corporate purposes. The sale was announced earlier this month. (See BioWorld Today, Dec. 8, 2003.)