• 454 Life Sciences Inc., of Branford, Conn., a majority-owned subsidiary of CuraGen Corp., received a $5 million grant over three years from the National Human Genome Research Institute to develop the company's technology as a method to sequence individual human genomes on PicoTiterPlates. The technology could lower the cost of sequencing a single mammalian genome, the company said.

• Acacia Research Corp., of Newport Beach, Calif., said its CombiMatrix Group and Science Applications International Corp., of San Diego, will work together to develop microarrays for the identification of multiple biothreat organisms. Both companies have Department of Defense contracts that provide funding to develop and test new identification and diagnostic assays and products against conventional biothreat agents and genetically engineered pathogens.

• Adventrx Pharmaceuticals Inc., of San Diego, said its lead compound, CoFactor, received orphan drug designation from the European Medicines Evaluation Agency for the treatment of pancreatic cancer. CoFactor also has orphan status in the U.S. Adventrx plans to submit a clinical trial application in the first quarter of 2005 in the European Union to conduct Phase II pancreatic cancer trials.

• Altachem Pharma Ltd., of Edmonton, Alberta, said the first scheduled group of patients with progressive Kaposi's sarcoma lesions has completed the Phase I trial. The trial is testing intralesionally injected ACP-HIP (hCG-like inhibitory proteins) in AIDS-KS patients. The trial is designed to evaluate the safety and tolerability of ACP-HIP in three groups of four patients, each at three different dose levels. All participants in the first group tolerated the drug very well and had no adverse or unexpected reaction.

• Avid Bioservices Inc., of Tustin, Calif., completed facility modifications and installation of a 1,000-liter mammalian cell culture bioreactor in its Tustin manufacturing facility. The company anticipates that it will begin manufacturing products under current Good Manufacturing Practices in the newly installed bioreactor in early 2005. Avid Biosciences provides cGMP manufacturing services for the biotechnology and biopharmaceutical industries.

• BioDelivery Sciences International Inc., of Newark, N.J., said its common stock will continue to be listed on the Nasdaq SmallCap Market. BioDelivery was granted an exception to the requirement that it maintain a minimum of $2.5 million in stockholders' equity as of June 30 if it can show compliance for the quarter ended Sept. 30. Until then, the company's symbol has changed to "BDSIC."

• Cellegy Pharmaceuticals Inc., of South San Francisco, said its new drug application for Cellegesic (nitroglycerin ointment, 0.4 percent) for pain associated with chronic anal fissures has been granted a priority review by the FDA. The company submitted the NDA this summer, and has been advised that the agency will decide on its approvability in early January. (See BioWorld Today, July 1, 2004.)

• Centocor Inc., of Malvern, Pa., and Schering-Plough Corp., of Kenilworth, N.J., said the European Commission granted approval of Remicade (infliximab) with methotrexate for the treatment of active and progressive psoriatic arthritis in patients who have responded inadequately to disease-modifying anti-rheumatic drugs. The approval follows a positive opinion granted in July by the Committee for Medicinal Products for Human Use. Centocor holds U.S. marketing rights, while Schering-Plough has marketing rights in all other countries, except Japan and parts of the Far East.

• Cerus Corp., of Concord, Calif., and Baxter International Inc., of Deerfield, Ill., are splitting a $15 million payment after closing a marketing partnership with BioOne Corp., of Tokyo, for Asian commercialization of the Intercept Blood System for platelets. BioOne will be responsible for commercializing the pathogen-inactivation technology for platelets in Japan, China, Taiwan, South Korea, Thailand, Vietnam and Singapore. The agreement, which was first reported in July, calls for additional milestone payments and royalties on future product sales. In connection with the agreement, Cerus made a $1.2 million equity investment in BioOne.

• CuraGen Corp., of New Haven, Conn., is advancing CR011, a fully human monoclonal antibody-drug conjugate, which will be investigated as a treatment for metastatic melanoma. CuraGen expects it will enter clinical trials during the first half of 2006. CR011 uses technology licensed from Seattle Genetics Inc., of Bothell, Wash., to attach cell-killing payloads to a fully human monoclonal antibody developed by CuraGen.

• Genzyme Corp., of Cambridge, Mass., and Inamed Corp., of Santa Barbara, Calif., received FDA approval for Hylaform Plus (Hylan-B gel), a large particle size hyaluronic acid-based dermal filler that is indicated for the correction of moderate to severe facial wrinkles and folds. The product was developed and is manufactured by Genzyme, while Inamed serves as the exclusive worldwide marketing and distribution partner. Another Hylaform product was approved earlier this year. (See BioWorld Today, April 26, 2004.)

• Immtech International Inc., of Vernon Hills, Ill., concluded a Phase I trial of DB289 in volunteers to establish the doses required for the combination trial for treating malaria. The study evaluated the pharmacokinetics of about 75 people who took DB289 for three days at 200 mg, 400 mg and 600 mg per day and tested the difference between once-per-day and twice-per-day dosing for three days. It indicated that at all levels tested, DB289 reached blood levels that should have a therapeutic effect in treating malaria. The results have been incorporated into a Phase II combination trial planned in Thailand for 120 patients with acute to moderate malaria.

• InNexus Biotechnology Inc., of Vancouver, British Columbia, got approval from the Toronto Stock Exchange for the acquisition of monoclonal antibodies and related intellectual property from ImmPheron Inc., of Lexington, Ky. InNexus said it plans to begin product development of the S(T15) SuperAntibody as its lead SuperAntibody product to reduce plaque in the treatment of coronary heart disease. In animal models, it has been demonstrated to reduce plaque by 20 percent to 25 percent. In separate news, InNexus agreed to a non-brokered private placement of 2.7 million share units at C$0.45 apiece, subject to acceptance for filing by the TSE. A finder's fee of 8 percent will be paid on closing, and InNexus also agreed to grant Williams de Broe plc a non-transferable option to acquire up to 200,000 common shares at C$0.45 each, exercisable for a period of two years from the offering's closing. The company said it would use the net proceeds for general working capital.

• Kos Pharmaceuticals Inc., of Miami, reported that the company, through its marketing partner Merck KgaA, of Darmstadt, Germany, received marketing authorization for Niaspan (niacin extended-release tablets) in France. Niaspan, developed and manufactured by Kos, is indicated in France for the treatment of dyslipidemia, particularly in patients with combined mixed hyperlipidemia

• Metaphore Pharmaceuticals Inc., of Fort Lee, N.J., said research published in last month's issue of Pain describes that superoxide is a key factor in glutamate-induced pain. Overproduction of glutamate is known to play a role in pain resulting from numerous disease states, including cancer and neuropathic pain. Metaphore's lead compound, M40403, is a synthetic version of superoxide dismutase, an enzyme that serves in a protective role in the body by removing superoxide. The company is testing its compound in two Phase II trials, one in post-operative pain and the other in cancer pain.

• Nutra Pharma Corp., of Boynton Beach, Fla., said its minority holding, ReceptoPharm Inc., reported the successful completion of studies in an animal model of multiple sclerosis. The drug, RPI-78M, proved to be effective in preventing the onset of disability in acute and chronic models of the disease. The drug also was effective at preventing the infiltration of immune cells into the central nervous system, the company said.

• PPD Inc., of Wilmington, N.C., and Syrrx Inc., of San Diego, reported the submission of an investigational new drug application for a Syrrx-designed human dipeptidyl peptidase IV inhibitor for the treatment of Type II diabetes. Pending FDA review, Phase I studies could begin in late October. Studies to date indicate that DPP IV plays an important role in regulating insulin levels in the body, the company said.

• QLT Inc., of Vancouver, British Columbia, said it would continue a Phase III trial of Visudyne (verteporfin for injection) to its 24-month endpoint following an analysis of 12-month data that included an independent analysis by a Data and Safety Monitoring Board. It recommended that the study should continue unchanged to its conclusion. The trial is designed to determine if photodynamic therapy with Visudyne can reduce the risk of vision loss in age-related macular degeneration patients with subfoveal occult with no classic choroidal neovascularization. Separately, in a study comparing Visudyne photodynamic therapy to anecortave acetate (from Alcon Inc.), an initial analysis of one-year data showed that the percentage of wet age-related macular degeneration patients who maintained vision was 49 percent for the Visudyne group and 45 percent with anecortave acetate.

• QTL Biosystems LLC, of Santa Fe, N.M., introduced its QTL LightSpeed Kinase platform and four new kinase activity assays to be released in October. The kinase platform is built using QTL's super-quenching polymer technology, which delivers universal mix and measure assays that do not require antibodies or radioactive labels. The kinase assays are used to target the molecular processes of the cell and to develop treatments for cancer, diabetes and other diseases, it said.

• Renovis Inc., of South San Francisco, said that AstraZeneca plc, of London, would continue as planned with Phase III trials to determine the effect of Cerovive (NXY-059) on disability and neurological recovery in acute ischemic stroke patients. The decision is based upon a recommendation from an independent Data and Safety Monitoring Board and the trial's steering committee, and follows a recent interim analysis of the trials (SAINT I and II). Cerovive, a neuroprotectant with free-radical-trapping properties, is being developed by AstraZeneca under a license from Renovis.

• Senesco Technologies Inc., of New Brunswick, N.J., said findings published in the October 2004 issue of Investigative Ophthalmology and Visual Science demonstrate that under the experimental conditions used inhibition of the company's Factor 5A gene protects human optic nerve cells from apoptosis. Blindness caused by glaucoma can result from TNF-alpha-induced apoptosis of the optic nerve.

• Sigma-Aldrich Corp., of St. Louis, partnered with Ingex LLC, also of St. Louis, to provide a gene-disruption technology called TargeTron, designed to offer a solution to the drawbacks of current siRNA and transposon-based methods. The system allows researchers to re-target the TargeTron group II intron for insertion into a host genome. Insertion results in permanent knockout of the target gene.

• Transition Therapeutics Inc., of Toronto, received clearance from the FDA to initiate a clinical trial for its lead diabetes product, E1-I.N.T., in Type I diabetes patients. The trial will evaluate a 28-day course of daily treatments with a six-month follow up. E1-I.N.T. is a short course combination therapy aimed at stimulating the regeneration of the body's insulin-producing cells.

• Trimeris Inc., of Durham, N.C., said net sales in the U.S. and Canada of the HIV drug Fuzeon for the third quarter were $21.1 million, compared to net sales of $24.4 million in the second quarter. Fuzeon, a fusion inhibitor, was granted accelerated approval by the FDA in March 2003. It also is approved in Canada and the European Union.

• Xanthus Life Sciences Inc., of Cambridge, Mass., initiated a second Phase I trial for Symadex to examine a daily dosing regimen in patients with advanced solid tumors. Symadex, which is part of the imidazoacridinone family, is a next-generation cancer agent designed to have similar or improved efficacy in comparison to the marketed chemotherapeutic Novantrone but with reduced side effects. Xanthus also is evaluating Symadex in a once weekly dosing regimen in a separate Phase I study.

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