• Acacia Research Corp., of Newport Beach, Calif., said its CombiMatrix Group and collaborator irsiCaixa, of Barcelona, Spain, entered an expanded three-year research, development and licensing agreement. They have chosen two siRNA candidates for preclinical development against HIV. CombiMatrix and its potential partners will pursue the preclinical development of the noted sequences with irsiCaixa providing research, as appropriate. CombiMatrix will provide irsiCaixa research funding, and could pay milestones and royalties. The agreement also covers additional virology work at irsiCaixa, including hepatitis C.

• ActiveSight, of San Diego, signed an agreement to provide structural biology services to Signal Pharmaceuticals LLC, a wholly owned subsidiary of Celgene Corp., of Warren, N.J. Efforts will focus on co-crystallography of Celgene's small molecules with a human drug target protein produced by ActiveSight. The agreement includes up-front fees and milestones payments.

• Adenosine Therapeutics LLC, of Charlottesville, Va., was awarded a Small Business Innovation Research grant from the National Institutes of Health in Bethesda, Md., for further study of its compounds in models of inflammatory bowel disease (IBD). The grant will fund development and testing of ATL-146e and a second-generation orally active compound as new therapies for the treatment of IBD. The amount of the award totals $640,879 over a two-year period.

• Affymetrix Inc., of Santa Clara, Calif., and ParAllele BioScience Inc., of South San Francisco, said scientists at Cambridge University in the UK would use the former's GeneChip Tag Arrays and the latter's MegAllele genotyping reagents in a genetic study of Type I diabetes. Affymetrix also said scientists at the Translational Genomics Research Institute in Phoenix and the Clinic for Special Children in Strasburg, Pa., found the genetic basis of one form of sudden infant death syndrome using Affymetrix SNP arrays. The researchers named the newly described form sudden infant death with dysgenesis of testes, or SIDDT. The research is published online in the Proceedings of the National Academy of Sciences.

• Applied Imaging Corp., of San Jose, Calif., renewed its exclusive supply agreement with StemCell Technologies Inc., of Vancouver, British Columbia, for the use of StemCell's RosetteSep reagent technology to isolate circulating tumor cells in the blood of cancer patients. The isolation and analysis of those cells might have clinical value in determining prognosis, response to therapy or monitoring strategies for certain cancers. RosetteSep will be used in conjunction with Applied Imaging's Ariol multiparameter cellular-analysis system.

• BioMarin Pharmaceutical Inc., of Novato, Calif., announced positive results from a pilot study of 6R-BH4 in 20 patients with phenylketonuria, showing it can lower blood phenylalanine levels and might allow patients to significantly relax or eliminate their restrictive, protein-free diet. 6R-BH4 is the active agent in Phenoptin, which received orphan drug status in the U.S. and European Union. The open-label study was conducted at two sites in the U.S., at which patients were given 10-mg/kg oral doses of 6R-BH4 daily for seven days.

• ConjuChem Inc., of Montreal, said preliminary results from its Phase I trial of DAC:GRF to treat growth hormone deficiency in children and adults showed the compound was well tolerated with no serious adverse events reported. The maximum tolerated dose was determined to be 125 mcg/kg. The trial enrolled 42 healthy volunteers in four ascending-dose cohorts. DAC:GRF is a chemically modified form of growth-releasing factor that covalently bonds to albumin, prolonging the half-life of GRF.

• Critical Therapeutics Inc., of Lexington, Mass., is enrolling about 60 healthy subjects in its second Phase I trial of CTI-01, an anti-inflammatory compound being developed for inflammatory conditions. The compound has demonstrated anti-inflammatory and tissue-protection activity in multiple animal models of disease, including pancreatitis, ischemia-reperfusion injury, sepsis, renal injury and endotoxemia.

• Cypress Bioscience Inc., of San Diego, said that Pierre Fabre Medicament SA, a division of Paris-based bioMerieux Pierre Fabre, milnacipran's originator, plans to set up a second milnacipran production site in Castres, France. The site would increase the production capacity for the molecule. Pierre Fabre has said that the additional production unit is expected to be operational in 2008. Earlier this year, Cypress and Forest Laboratories Inc., of New York, reported they had entered a collaboration for the development and marketing of Cypress's milnacipran, licensed from Pierre Fabre Medicament, for indications in the U.S. market. (See BioWorld Today, Jan. 12, 2004.)

• Cytorex Biosciences Inc., of Weston, Fla., concluded cytotoxicity testing in cancer and healthy cell cultures with the compound Cytoreg, with selective cytotoxicity activity against cancer cells, high-antioxidant and free-radical stress capability. In healthy cells tested at the same doses as cancer cells, the cytotoxicity profile was low, making Cytoreg a potential safe and effective first-line agent for the treatment of different cancer indications, the company said.

• Enzo Biochem Inc., of New York, said its subsidiary Enzo Life Sciences signed a license and supply agreement with GlaxoSmithKline plc, of London, for Enzo's RNA/DNA labeling, detection and amplification technology and products. Financial terms were not disclosed. The agreement includes a nonexclusive license to GSK under certain Enzo patents to generate genomic information to support GSK's research and development activities.

• GeneMax Corp., of Vancouver, British Columbia, said data reported at the combined International Congress of Immunology and Conference of the Federation of Clinical Immunology Society in Montreal showed that its TAP-1 cancer vaccine treated animal models of lung cancer. The vaccine, which is designed with the human version of TAP-1 together with a nonreplicating adenovirus that is applicable for use in humans, was able to increase the survival rate, retard tumor growth and promote a centralized immune response to the cancer. The studies showed that the immune system of the animal had been sufficiently armed to locate cancerous cells throughout the animal and to prevent metastases.

• Hemispherx Biopharma Inc., of Philadelphia, received FDA authorization to initiate a clinical trial with Alferon N injection to treat multiple sclerosis. The multicenter, open-label Phase IIb trial will determine the safety and efficacy of Alferon N injection in patients with relapsing-remitting MS who have discontinued interferon-beta therapy because of clinical progression or intolerance, or who have developed neutralizing antibodies to interferon-beta. Alferon N is a glycosylated, multispecies, alpha-interferon product, composed of eight forms of highly purified alpha-interferon.

• ID Biomedical Corp., of Vancouver, British Columbia, reported preliminary results from its first large-scale field efficacy study of FluINsure, a non-living intranasally delivered influenza vaccine. The field study was initiated at 28 sites in Canada during the 2003 and 2004 flu seasons. In total, 1,349 healthy subjects aged 18 to 64 were randomly enrolled in three study arms. Results showed that one dose of the vaccine was slightly more efficacious than two doses of the FluINsure vaccine, but there was no statistically significant difference between the two regimens. ID Biomedical's stock (NASDAQ:IDBE) rose $2.51 Tuesday, or 32 percent, to close at $10.35.

• Illumina Inc., of San Diego, entered a collaboration for the design and validation of gene marker panels with Genomas Inc., of New Haven, Conn. Genomas will use the Illumina BeadStation 500GX for the discovery of diagnostic markers to be used in the development of Physiotypes, which are predictors incorporating haplotypes from various genes, baseline physiological and clinical information, as well as demographic data. Genomas will develop PhysioTypes for the prediction of an individual's response to exercise, diet and drug regimens to personalize prevention and treatment of obesity and the related metabolic syndrome that leads to diabetes and cardiovascular disease.

• Inex Pharmaceuticals Corp., of Vancouver, British Columbia, said data reported at the combined International Congress of Immunology and Conference of the Federation of Clinical Immunology Society in Montreal showed that its preclinical targeted immunotherapy product, INX-0167, has the potential to enhance the antitumor activity of monoclonal antibodies. The data demonstrate the ability of INX-0167 to enhance natural killer-cell activity, resulting in an improvement in the antitumor efficacy of monoclonal antibodies when tested in lymphoma and breast cancer models. INX-0167 is the encapsulation of immunostimulatory oligonucleotides in the company's liposomal technology.

• Juvaris BioTherapeutics Inc., of Pleasanton, Calif., entered a research agreement with Cell Genesys Inc., of South San Francisco, to use Juvaris' therapeutic immunostimulant platform in cancer models. The collaboration will encompass evaluation in preclinical studies of the combined use of Juvaris' cationic lipid-DNA complexes with certain Cell Genesys product candidates. The evaluation program is expected to continue for 10 to 12 months.

• Locus Pharmaceuticals Inc., of Blue Bell, Pa., acquired a four-year-old drug discovery company called Protein Mechanics Inc., of Mountain View, Calif. Locus said the purchase brings on board simulation technology for the design of small-molecule therapeutics, which it called synergistic with its ability to computationally design new drug candidates specific to selected clinical protein targets. Locus' core technology identifies viable drug-binding sites on the surface of proteins and directs the de novo assembly of fragments into small-molecule product candidates. Financial terms of the acquisition were not disclosed.

• Micrologix Biotech Inc., of Vancouver, British Columbia, said data published in Antiviral Chemistry & Chemotherapy demonstrate the efficacy of MBI-3253 (celgosivir) against the surrogate model of the hepatitis C virus, bovine viral diarrhea virus. Other data indicated additive and synergistic effects of MBI-3253 in combination with ribavirin alone or interferon-a, confirmed its mechanism of viral-replication inhibition and demonstrated a lack of cellular toxicity at high drug concentrations in a variety of cell lines.

• Myriad Genetics Inc., of Salt Lake City, said Phase I data reported at the International Conference on Alzheimer's Disease and Related Disorders in Philadelphia showed that Flurizan (R-flurbiprofen, MPC-7869) was safe and well tolerated following 21-day administration in healthy elderly volunteers. The company said data from the 48-person study complement the safety record established in three other completed trials. Flurizan remains in a three-arm Phase II trial to assess efficacy in about 200 patients with mild to moderate Alzheimer's disease in the UK and Canada.

• NeoPharm Inc., of Lake Forest, Ill., appointed Gregory Young president and CEO. Young succeeds James Hussey, who resigned from NeoPharm to pursue other opportunities. Most recently, Young was a corporate vice president at Baxter Healthcare Corp. and president of Baxter's transfusion therapies division. NeoPharm is focused on the research, development and commercialization of cancer drugs.

• Oscient Pharmaceuticals Corp., of Waltham, Mass., closed enrollment in a study of Ramoplanin for the prevention of vancomycin-resistant enterococci in order to devote its resources to the Clostridium difficile-associated diarrhea (CDAD) indication. The VRE study originally was designed to enroll up to 950 neutropenic cancer patients, but enrollment was slow. Oscient completed enrollment in June for the Phase II trial to treat CDAD. In other news, the company plans to investigate a shorter course of treatment of its FDA-approved Factive tablets. The new preparation would be given over five days. The non-inferiority, double-blind study will be conducted at up to 100 North American and European sites and will enroll about 459 patients.

• OSI Pharmaceuticals Inc., of Melville, N.Y., completed the previously announced redemption of all of its 4 percent convertible senior subordinated notes due February 2009. The outstanding principal amount of the notes was $160 million. Holders of all outstanding notes converted them into OSI shares of common stock prior to the July 19 redemption date. None of the outstanding principal amount of notes was redeemed for cash. About 3.2 million shares of OSI's common stock will be issued to the note holders. OSI will pay $6.4 million in cash to the holders of notes surrendered for conversion after the announcement of the redemption.

The Pacific Exchange in San Francisco said it would begin trading options on Adolor Corp., of Exton, Pa.; Eyetech Pharmaceuticals Inc., of New York; and Pharmion Corp., of Boulder, Colo. Adolor options will trade on the January expiration cycle, while Eyetech and Pharmion will trade on the March expiration cycle.

• Power3 Medical Products Inc., of The Woodlands, Texas, secured the exclusive worldwide licensing rights from Baylor College of Medicine for serum proteomics methods and biomarkers for the differential diagnosis of Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis, and other motor neuron and neurological disorders. The technology was co-developed by Power3 and Baylor. Power3 paid Baylor a licensing fee and will make additional milestone payments. Baylor also is entitled to royalties.

• Praecis Pharmaceuticals Inc., of Waltham, Mass., said preclinical results published in the July 20, 2004, issue of the Proceedings of the National Academy of Sciences point to the use of its investigational compound, PPI-2458, as a potential treatment for rheumatoid arthritis. The findings demonstrate that the molecule inhibits the growth of both human fibroblast-like synoviocytes derived from rheumatoid arthritis patients and human endothelial cells. Also, the data demonstrate that growth inhibition of PPI-2458-sensitive cells in rheumatoid arthritis is linked to MetAP-2 inhibition in a dose-dependent fashion. Praecis and the National Cancer Institute in Bethesda, Md., have tested PPI-2458 in cellular and animal models, and the company expects to begin a Phase I study in non-Hodgkin's lymphoma patients during this half of the year.

• Procyon Biopharma Inc., of Montreal, completed the enrollment of the 200 patients required for its North American Phase IIb trial with Fibrostat, its topical therapeutic intended for the treatment of hypertrophic scars resulting from surgery or burns. The company expects to announce the results of the placebo-controlled, double-blind, randomized study during the fourth quarter.

• San Luigi Gonzaga Hospital in Torino, Italy, said one of its researchers published findings in this month's Journal of the Neurological Sciences showing that relapsing-remitting multiple sclerosis patients who are treated with high-dose, high-frequency interferon beta-1b (Betaferon/Betaseron, from Chiron Corp. and Berlex Laboratories Inc.) should stay on the regimen and avoid switching to low-dose, once-weekly interferon beta-1a (Avonex, from Biogen Idec Inc.), even in the absence of clinical or MRI signs of disease activity. Data showed that 23 percent of those on the interferon beta-1a regimen remained free from relapses, compared with 79 percent of those receiving interferon beta-1b (p=0.006). Also, the relapse rate was significantly higher in those receiving interferon beta-1a (p=0.03), and the time to first relapse was significantly shorter (p=0.001).

• Sinovac Biotech Ltd., of Beijing, received $1.2 million in research funding from the Chinese state government for its inactivated severe acute respiratory syndrome vaccine development program. To date, Sinovac said it has received $2.2 million in government support for its SARS vaccine program.

• Tm Bioscience Corp., of Toronto, entered a multiyear agreement to supply LabOne Inc., of Lenexa, Kan., a diagnostics services provider, with the company's Tag-It brand mutation-detection tests. LabOne's senior vice president, Rich Sokol, said that "genetic testing is an important area of growth for LabOne."

• Tripos Inc., of St. Louis, was selected by the European Molecular Biology Laboratory (EMBL) and the German Cancer Research Centre (DKFZ) to assist in rapid identification of potential molecular leads. EMBL and DKFZ jointly established one of the first European academic small-molecule screening facilities in Heidelberg, Germany. Tripos Discovery Research Ltd., the company's UK-based discovery chemistry division, will employ its chemistry knowledge base and process to facilitate rapid hit finding, hit follow-up and chemical optimization of candidate molecules.

The University of Texas at Austin said a group of its biomedical engineers received an $8 million grant from the National Cancer Institute in Bethesda, Md., to learn more about the genetics of cancer development. The researchers also will work to create methods to diagnose and monitor the disease. The study will focus on cancers of the lung, cervix and oral cavity.

• VaxGen Inc., of Brisbane, Calif., intends to adopt a revised revenue-recognition policy for certain contracts, most of which are with the National Institute of Allergy and Infectious Diseases. The revised policy will allow the company to expeditiously update its financial reports and return to compliance with the Nasdaq Stock Market listing standards. The company intends to restate its financial statements for the years 2003 and 2002. The restatement will have no effect on VaxGen's cash position and will result in a material increase in revenues and a decrease in net loss applicable to stockholders for the combined periods.

• Xenome Ltd., of Queensland, Australia, said that it began a Phase I trial of its neuropathic pain drug Xen2174. The trial is a randomized, placebo-controlled, double-blind, dose-escalating study involving up to 20 healthy male volunteers. The primary purpose of the trial is to evaluate the safety and tolerability of Xen2174 following intravenous administration.

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