• Advanced Magnetics Inc., of Cambridge, Mass., and Cytogen Corp., of Princeton, N.J., said Advanced Magnetics submitted a complete response to the approvable letter received in June 2000 from the FDA for Combidex, a molecular imaging agent. The Sept. 30 submission has been accepted and assigned a user-fee goal date of March 30. Combidex (ferumoxtran-10) consists of iron oxide nanoparticles for use in conjunction with magnetic resonance imaging to aid in the differentiation of cancerous from noncancerous lymph nodes. Advanced Magnetics' stock (AMEX:AVM) jumped $2.88 Tuesday, or 23.5 percent, to close at $15.15. Cytogen's stock (NASDAQ:CYTO) rose 21 cents to close at $10.58.

• Aeolus Pharmaceuticals Inc., of Denver, said that new data demonstrate that the administration of one of its antioxidant mimetics, AEOL 10150, to human pancreatic islet cells during isolation leads to substantial protection of those islets. Recent experiments published in Diabetes show that administration of AEOL 10150 during isolation blocks the activation of NFKappaB and subsequent pro-inflammatory cytokine production in pancreatic islets.

• Alnylam Pharmaceuticals Inc., of Cambridge, Mass., and Isis Pharmaceuticals Inc., of Carlsbad, Calif., coexclusively licensed certain core intellectual property relating to all therapeutic uses of microRNA from the Max Planck Society. MicroRNAs are naturally expressed small RNAs that interact with components shared by the RNA-induced silencing complex (RISC), an enzyme complex by which the RNA interference pathway operates. It increasingly is believed that microRNAs play a central role in the regulation of gene expression in mammalian cells, the companies said, adding that abnormalities in their function might play a role in human disease. The society granted rights to patent applications based on the microRNA work of Thomas Tuschl, one of Alnylam's founders. Garching Innovation GmbH, the society's technology-transfer agency, facilitated the transaction. Financial terms were not disclosed.

• BioCryst Pharmaceuticals Inc., of Birmingham, Ala., said the first patient was dosed in a Phase I trial of oral forodesine hydrochloride, its lead cancer compound formerly known as BCX-1777, in refractory patients with cutaneous T-cell lymphoma. Forodesine hydrochloride is a purine nucleoside phophorylase inhibitor, which functions by blocking the T cell's DNA-synthesis machinery. The small-molecule drug is being developed for treatment of T-cell-mediated cancers and has been designated an orphan drug.

• BioSante Pharmaceuticals Inc., of Lincolnshire, Ill., presented new Bio-E-Gel (bioidentical estradiol transdermal gel) Phase II efficacy data Tuesday at the annual meeting of the American Society for Reproductive Medicine in Philadelphia. The data show that Bio-E-Gel reduced the frequency of moderate to severe hot flashes by at least 90 percent in 55 percent of subjects and by at least 95 percent in 50 percent of subjects, both of which were significant vs. placebo (p<0.05). Also, there was a 100 percent reduction in hot flashes in 24 percent of subjects receiving the effective dose, compared to only 10 percent of subjects receiving placebo.

• BioVeris Corp., of Gaithersburg, Md., is expanding its business model to target the fields of immunogenicity, vaccines and vaccination services. The company introduced its products for testing protein-based therapeutics and is developing an approach to determine an individual's personal immune status through a diagnostic test panel. In conjunction with its new efforts, BioVeris entered an exclusive option agreement with Children's Hospital & Research Center at Oakland in California for the right to negotiate for exclusive patent rights to a vaccine candidate for Neisseria meningitidis serogroup B, which causes meningitis.

• Cangene Corp., of Toronto, reported that the Centers for Disease Control and Prevention in Atlanta intends to negotiate a sole-source agreement with Cangene to provide up to 200,000 doses of botulinum toxin immune globulin. Cangene intends to develop and manufacture product for use under an investigational new drug application.

• Celera Diagnostics Inc., of Alameda, Calif., identified genetic variants associated with late-onset Alzheimer's disease. The findings, to be published online this week in the Proceedings of the National Academy of Sciences, involve single nucleotide polymorphisms in genes for an enzyme involved in glucose metabolism called glyceraldehyde-3-phosphate dehydrogenase, which also is involved in neuronal apoptosis. Celera Diagnostics is a joint venture between the Celera Genomics Group and Applied Biosystems Group of Applera Corp.

• Chiron Corp., of Emeryville, Calif., and Gen-Probe Inc., of San Diego, said a design dossier amendment for use of the Procleix Ultrio Assay on the Procleix Tigris System has been submitted to Gen-Probe's European notified body. The amendment would allow the already CE-Marked assay to be run on the Tigris high-throughput instrument platform, as well as on the Procleix System, which is a semi-automated instrument platform. Procleix Ultrio was developed to simultaneously detect HIV-1, hepatitis C and hepatitis B in donated blood, plasma, organs and tissue. In the U.S., a biologics license application was submitted several weeks ago.

• DeCode Genetics Inc., of Reykjavik, Iceland, reported the principal results from its Phase IIa trial of DG031, its developmental compound being studied for the prevention of heart attack. The trial was designed to examine the effect of various doses of DG031 on certain biomarkers linked to arterial inflammation and the risk of heart attack in patients with a history of heart attack and one or more of the gene variants DeCode has linked to increased risk of disease. The trial achieved its primary efficacy endpoint of demonstrating a reduction in one or more of the key biomarkers.

• Dong-A PharmTech Co. Ltd., of Seoul, South Korea, said Phase II results reported at the World Congress of the International Society for the Sexual and Impotence Research in Buenos Aires, Argentina, showed that DA-8159 produced a significant improvement in erectile function after 12 weeks of drug therapy. Use of the oral phosphodiesterase type-5 inhibitor resulted in up to a 91 percent vaginal penetration success rate and up to 67 percent intercourse completion rate, compared to 29 percent for the placebo group. The study evaluated 319 men, and DA-8159 was well tolerated at both the 100-mg and 200-mg dose levels.

• Exelixis Inc., of South San Francisco, completed its acquisition of X-Ceptor Therapeutics Inc., of San Diego, which focuses on the discovery and development of small molecules that modulate nuclear hormone receptors. Pursuant to the merger agreement on Sept. 8, Exelixis acquired all of the outstanding shares of capital stock of X-Ceptor in exchange for about 2.5 million shares of Exelixis stock and about $2.9 million in cash. The deal was valued at $22.3 million. (See BioWorld Today, Sept. 29, 2004.)

• Genospectra Inc., of Fremont, Calif., extended its intellectual property portfolio to include special state-responsive dyes. The dyes have been used to create novel live-cell biosensors that localize and quantify protein-protein interactions in real-time, such as sites of specific binding and phosphorylation events. The company also develops technologies and products for Parallel Quantitative Biology.

• Halozyme Therapeutics Inc., of San Diego, presented data at the Technology Pavilion of the American Society of Reproductive Medicine 2004 annual meeting in Philadelphia. It presented comparative data on the use of Cumulase vs. the currently used slaughterhouse-derived extracts in certain IVF procedures. The studies revealed that after extended exposure to Cumulase, murine oocytes demonstrated fertilization rates similar to natural IVF, whereas in the same time period oocytes exposed to bovine hyaluronidase experienced about a 50 percent decrease in viability relative to natural IVF or Cumulase-treated oocytes. In addition, the purity of Cumulase is more than 100-fold higher than animal preparations, the company said.

• Human Genome Sciences Inc., of Rockville, Md., used all of the net proceeds from its private placement of $280 million principal amount of 2 percent convertible subordinated notes due 2011 to complete its planned repurchase of a portion of its outstanding convertible debt. The repurchase includes $218.1 million principal amount of the company's 3 percent convertible subordinated notes due 2007, and $60.1 million of the company's 5 percent convertible subordinated notes due 2007. Initial purchasers of the private placement closed on Oct. 4, have the option until Oct. 29 to purchase an additional $20 million principal amount of 2 percent convertible subordinated notes due 2011. If the option is exercised, HGS intends to use additional net proceeds to repurchase, from time to time, an additional portion of its outstanding convertible subordinated debt.

• Insert Therapeutics Inc., of Pasadena, Calif., a majority-owned subsidiary of Arrowhead Research Corp., is planning with the City of Hope Comprehensive Cancer Center a Phase I trial for Insert's lead drug candidate, a combination of its patented polymer technology, Cyclosert, and the cancer compound camptothecin. Insert is in final rounds of preclinical testing and is engaged in the scale-up of the drug to produce cGMP-grade clinical materials.

• KAI Pharmaceuticals Inc., of South San Francisco, said that Steven James was appointed president and CEO. John Walker, who served as acting CEO, will remain on the company's board. James most recently was senior vice president of commercial operations at Exelixis Inc. KAI has clinical and preclinical therapeutic programs for the acute treatment of ischemia and reperfusion injury and for diseases involving chronic regulation of angiogenesis.

• Kinexis Inc., of Carlsbad, Calif., reached an initial research milestone in its drug discovery program with Merck & Co. Inc., of Whitehouse Station, N.J. Kinexis and Merck have been collaborating during the past year on the biologic target validation of a prokineticin receptor in central nervous system indications. Merck made an undisclosed cash payment to Kinexis. Kinexis is entitled to receive additional milestone payments, as well as royalties.

• Liponex Inc., of Ottawa, Ontario, was granted a U.S. patent allowance for its first product, CRD5, a drug in development for the treatment of cholesterol and atherosclerosis. The company also reported the results of Phase I trials of CRD5, which showed significant primary efficacy results, indicating that CRD5 increased levels of HDL cholesterol by an average of 18 percent in the high-dose group over the same two-week period.

• Lynx Therapeutics Inc., of Hayward, Calif., said the National Science Foundation has awarded a research grant to the University of Delaware to use Lynx's Massively Parallel Signature Sequencing technology to develop methods to capture and sequence small RNAs (21 to 24 ribonucleotides) on a larger scale than previously possible. The new application lets researchers discover small RNAs and quantify their expression patterns. The non-coding RNAs primarily are involved in degradation of messenger RNAs, but also function in the inhibition of translation and direct silencing of genes via the methylation of DNA.

• MacroGenics Inc., of Rockville, Md., and OriGene Technologies Inc., also of Rockville, entered a license agreement for a cancer target initially identified with OriGene's HTP-Rapid-Scan technology. MacroGenics has the exclusive right to develop compounds against the target and will focus on the development of therapeutic monoclonal antibody candidates to that molecule. In exchange, OriGene will be entitled to receive various option fees, milestones and royalty payments.

• Molecular Diagnostics Inc., of Chicago, and its wholly owned subsidiary, AccuMed International Inc., settled the dispute with MonoGen Inc., of Vernon Hills, Ill., that arose from a December 2000 agreement in which AccuMed granted MonoGen a license to technologies that might be used, in part, for early cancer detection, diagnosis and monitoring. As part of the settlement, AccuMed assigned to MonoGen all of its patents, patent applications, trade secrets, trademarks, copyrights and know-how covering the subject patents and technology, as well as all applicable equipment and spare parts.

• NeoPharm Inc., of Lake Forest, Ill., said the Institutional Shareholder Services reached the wrong conclusion in its recommendation regarding a consent solicitation brought by the company's former chairman, John Kapoor. The current board said it believes the election of Kapoor's nominees to the board would undermine clinical trials, disrupt management and be detrimental to shareholders. Kapoor entered a bid to change the drug development company's direction last month. (See BioWorld Today, Sept. 7, 2004.)

• Odyssey Thera Inc., of San Ramon, Calif., granted an exclusive worldwide license to its technology to Panbio Ltd., of Brisbane, Australia, for use in the development of a new system for the detection of disease in humans and animals. While specific financial terms were not disclosed, Panbio will pay Odyssey up-front license fees and royalties.

• Parker Hughes Cancer Center in Roseville, Minn., developed a new technology to prevent the development of breast cancer in mice. The results of those research studies will be published in two back-to-back papers in the November 2004 issue of the international medical journal Arzneimittelforschung (Drug Research). The technology was developed through the combined use of chemistry, biology, bioinformatics, pharmacology and mathematics.

• Potomac Pharma Inc., of Bethesda, Md., said that the Stanley Medical Research Institute, also in Bethesda, agreed to contribute up to $2.2 million toward the development of its alpha-2 antagonist for the treatment of schizophrenia. In Phase II studies conducted by the National Institute of Mental Health, the company's lead compound, P-101, demonstrated statistically significant improvements of positive and negative symptoms in patients with schizophrenia, when used in combination with current anti-psychotics. Additional Phase II trials will begin during the fourth quarter.

• PTC Therapeutics Inc., of South Plainfield, N.J., reported single-dose Phase I trial data for the company's lead candidate, PTC124. PTC124 is a small-molecule drug being investigated initially as a treatment for a subset of patients with cystic fibrosis and Duchenne's muscular dystrophy due to nonsense mutations, with the potential to treat other genetic disorders. The results were presented at the 18th annual North American Cystic Fibrosis conference in St. Louis.

• Ruhr University in Germany said its researchers reported data at the American College of Rheumatology meeting in San Antonio in which analysis of a magnetic resonance imaging study showed that significantly more ankylosing spondylitis patients treated with Enbrel (etanercept) had regression of spinal inflammation compared to placebo. Specifically, the MRIs showed 73 percent of Enbrel patients experienced a significant regression in active inflammatory spinal lesions, while 13 percent taking placebo experienced continued deterioration. The changes were detectable in as early as six weeks. The drug is marketed by Amgen Inc., of Thousand Oaks, Calif., and Wyeth, of Madison, N.J.

• Samaritan Pharmaceuticals Inc., of Las Vegas, and Georgetown University in Washington said the National Institutes of Health has awarded a $100,000 grant to research their Alzheimer's disease treatment, SP-004, which is believed to bind the sigma-1 receptor and also has properties to inhibit acetylcholinesterase (AchE). Several Alzheimer's drugs that inhibit AchE already are approved by the FDA, but Samaritan believes it has identified compounds that, in combination, inhibit AchE and the sigma-1 receptor at the same time.

• Sangamo BioSciences Inc., of Richmond, Calif., said preclinical data published in Circulation demonstrate the utility of zinc finger DNA-binding protein transcription factors (ZFP TFs) as a new class of human therapeutics for the treatment of peripheral artery disease. Using ZFP TFs to increase the expression of a gene and the protein that it encodes in ischemic muscle in rabbits resulted in statistically significant changes in a number of measures of efficacy in treated limbs: decrease in cell death in the treated muscle, increased cell growth and blood vessel density and increases in blood flow. The ZFP therapeutic being tested was developed by Sangamo scientists in partnership with Edwards Lifesciences Corp., of Irvine, Calif., and is being tested in a Phase I trial being conducted at the National Institutes of Health in Bethesda, Md.

• Savient Pharmaceuticals Inc., of East Brunswick, N.J., said Phase I data reported at the American College of Rheumatology meeting in San Antonio detailed the use of Puricase (PEGylated uricase) in severe gout. Based on those results, the company is conducting a multicenter, dose-ranging Phase II study to test repeated intravenous administration of Puricase in patients with severe refractory gout. Savient plans to complete the trial this year.

• Senesco Technologies Inc., of New Brunswick, N.J., licensed its gene technology to The Broin Companies, of Sioux Falls, S.D., to improve aspects of ethanol production capabilities. If research and development is successful, Senesco expects that its technology will be implemented throughout all of Broin's ethanol production facilities, and Senesco will get an annual payment for each. Adoption of the technology in Broin's plants could lead to annual payments of more than $1 million.

• Serono SA, of Geneva, said that in the first clinical trial to compare gonadotropin-releasing hormone antagonists, patients using Cetrotide (cetrorelix acetate for injection) required fewer injections compared to patients using Ganirelix Acetate (formerly known as Antagon) to prevent premature ovulation during infertility treatment. The data were presented at the 60th annual meeting of the American Society for Reproductive Medicine in Philadelphia.

• ViroLogic Inc., of South San Francisco, and Aclara BioSciences Inc., of Mountain View, Calif., modified the terms of the contingent value rights (CVR) in their previously executed definitive merger agreement. The exchange ratio remains unchanged with each outstanding share of Aclara common stock to be exchanged for 1.7 shares of ViroLogic and 1.7 CVR. The CVR terms were modified by increasing the maximum potential payment, allowing for the increase in the potential payment to be made in stock at the option of ViroLogic, extending the time until the determination date for the payment amount by six months for a total of 18 months and reducing the ViroLogic stock price at which the maximum payment may be made. At the same time, ViroLogic said revenue for the full year will come in below the low end of its previous guidance of $38 million to $41 million because it expects to report third-quarter revenue of about $8.6 million compared to $9.2 million a year ago.

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