• Aastrom Biosciences Inc., of Ann Arbor, Mich., received a $109,586 Phase I Small Business Innovation Research grant from the National Cancer Institute in Bethesda, Md. The eight-month study will determine the efficacy and ability of the company's AastromReplicell System to enhance the immunostimulatory potency of dendritic cell-based cancer vaccines through its patented Single-Pass Perfusion technology. The SBIR study will use the system for the production, cancer antigen-loading, maturation and harvesting of human dendritic cells.

• Accelrys Inc., of San Diego, entered an agreement to integrate St. Louis-based Sigma-Aldrich Corp.'s chemical compound catalogs into Accelrys' chemical suppliers database, Chemicals Available for Purchase. Financial terms were not disclosed.

• Access Pharmaceuticals Inc., of Dallas, received approval of its new drug application for OraDisc A from the FDA. The product is a delivery system for amlexanox, which is approved to treat canker sores. The OraDisc technology is a mucoadhesive patch that gradually erodes and releases an active ingredient when applied to the inside of the mouth. The approval provides for the use of the amlexanox mucoadhesive patch 2 mg to treat aphthous ulcers in adults and adolescents 12 years of age and older with a normal immune system.

• Aclara BioSciences Inc., of Mountain View, Calif., said researchers presented posters at the EORTC-NCI-AACR symposium that demonstrate the ability of Aclara's eTag System to selectively and quantitatively detect protein-protein interactions involved in the aberrant activation of tyrosine kinase. The system could improve the management of cancer by facilitating individualized treatment based on the specific molecular phenotype of a patient's tumor, the company said.

• Ariad Pharmaceuticals Inc., of Cambridge, Mass., began enrolling patients with bone and soft-tissue sarcomas in the first multicenter Phase II trial of mTOR inhibitor, AP23573, as a single agent in solid tumors. The non-randomized study will evaluate benefit in four groups of sarcoma patients. Up to 175 patients will be enrolled at 15 centers in the U.S. and Europe. Ariad also reported Phase I data on AP23573 at the EORTC-NCI-AACR symposium showing tumor regression in patients with advanced cancers, most of whom had progressive disease and all had failed alternative treatments. Of 49 evaluable patients in two trials, tumor regression was seen in nine patients and disease stabilization was achieved in an additional 15 patients.

• Centocor Inc., of Malvern, Pa., said the FDA approved an expanded label for Remicade (infliximab) in combination with methotrexate as a first-line regimen to treat patients with moderate to severe rheumatoid arthritis. The expanded label eliminates the requirements that patients must fail to respond to methotrexate before starting on the Remicade regimen.

• Connetics Corp., of Palo Alto, Calif., signed a license agreement granting Pierre Fabre Dermotologie, of Castres, France, exclusive commercial rights to Olux (clobetasol propionate) Foam, 0.05 percent for Europe, excluding Italy where the product is licensed to Mipharm SpA, of Milan. The agreement with Pierre Fabre also grants marketing rights for certain countries in South America and Africa. The product will be marketed by Pierre Fabre under different trade names. Connetics will receive an up-front license payment, potential milestone payments and royalties. Pierre Fabre will be responsible for costs associated with product manufacturing, sales, marketing and distribution in its licensed territories.

• Cubist Pharmaceuticals Inc., of Lexington, Mass., filed with the SEC a shelf registration statement for the proposed offering from time to time of up to $100 million of Cubist stock. Cubist is focused on the research, development and commercialization of anti-infective products.

• Cyntellect Inc., of San Diego, and SC Biosciences, of Tokyo, formed a marketing agreement in which SC will exclusively market Cell Xpress cell line development service in Japan. The service is based on Cyntellect's high-throughput LEAP platform, and offers accelerated cloning of cell lines possessing ideal growth and protein-secretion properties, Cyntellect said.

• Delcath Systems Inc., of Stamford, Conn., said the National Cancer Institute started treating patients in a Phase II trial using the company's technology to deliver high doses of melphalan for patients with inoperable liver cancers. It is the NCI's second human study of the system. The first study, a Phase I, showed that 60 percent of the evaluable cancer patients experienced antitumor activity with more than half of the responding patients achieving tumor shrinkage of greater than 50 percent. The new study will enroll up to 25 patients.

• Diversa Corp., of San Diego, launched Bayovac SRS in Chile. The vaccine is designed to prevent salmonid rickettsial septicemia in farmed salmon. Diversa manufactures the microbially produced vaccine, and Bayer Animal Health, of Shawnee Mission, Kan., is exclusively distributing and marketing the product in Chile.

• Genaera Corp., of Plymouth Meeting, Pa., received a $100,000 Small Business Innovation Research grant from the National Eye Institute of the National Institutes of Health to further develop squalamine-related aminosterols as next-generation anti-angiogenic medications to treat wet age-related macular degeneration. Squalamine has been shown to preserve or improve vision in all wet AMD patients four months after initiation of therapy in a Phase I/II trial. Genaera will evaluate analogues of squalamine to identify additional compounds with improved features as potential second-generation therapies for treating wet AMD.

• GenOway, of Lyon, France, entered a research agreement with Pfizer Inc., of New York, to provide Pfizer researchers in the U.S. with a genetically modified rat model based on GenOway's nuclear transfer program. It is GenOway's second agreement with the biopharmaceutical sector to generate conditional knockout and knock-in rat models.

• Gen-Probe Inc., of San Diego, and Chiron Corp., of Emeryville, Calif., said that a biologics license application for the Procleix Ultrio blood-screening assay was submitted to the FDA. The Procleix Ultrio Assay was developed to detect HIV-1, hepatitis C virus and hepatitis B virus in donated blood, plasma, organs and tissue. The companies intend to seek approval to run the test on both the semi-automated Procleix System and on the fully automated, high-throughput Procleix Tigris System.

• GPC Biotech AG, of Martinsried, Germany, said that data on its cancer monoclonal antibody, 1D09C3, were presented at the 16th annual EORTC-NCI-AACR meeting in Geneva. The data demonstrate that 1D09C3 selectively induced apoptosis in a variety of xenotransplant lymphoid tumor models. It is an anti-MHC (major histocompatibility complex) Class II monoclonal antibody that binds to certain cell-surface receptors, selectively killing activated, proliferating MHC Class II-positive tumor cells.

• Invitrogen Corp., of Carlsbad, Calif., entered new licensing agreements to supply Gateway Technology and clones to major genomic research centers on two continents. Those include Open Biosystems, a U.S.-based distributor of genomic and proteomic research products; the UK Medical Research Council, the national organization funded by the UK government to promote medical research; and RZPD, or Ressourcenzentrum fur Genomforschung, the not-for-profit German service center for genomics and proteomics research. Gateway Technology is designed to provide a platform that allows a single entry clone to be inserted into as many expression vectors as needed to study its functions without repeating the initial cloning.

• Keryx Biopharmaceuticals Inc., of New York, said Phase II data demonstrated the tolerability and potential efficacy of KRX-0402 (perifosine) in the treatment of patients with advanced soft-tissue sarcoma. The study was conducted by the National Cancer Institute and enrolled 23 patients. They received a loading dose of 150 mg of KRX-0401 every six hours on the first day, then a dose of 100 mg on each following day of therapy. There was one confirmed partial response lasting more than five months, and two patients remained progression-free at six months. Perifosine was in-licensed by Keryx from Quebec City-based AEterna Zentaris Inc., which holds rights to the drug outside North America. In other news, Keryx filed a shelf registration statement with the SEC to sell 5 million shares of common stock, but the company has no immediate plans to raise funds.

• LAB International Inc., of Laval, Quebec, reported positive results from the Phase I/II trial for its 29-amino-acid-peptide analogue of growth hormone-releasing hormone. The results showed a significant increase in the levels of growth hormones at all doses and all subjects after administration. Moreover, the drug was safe at all doses administered.

• Ligand Pharmaceuticals Inc., of Baltimore, is the subject of a securities class-action lawsuit that was begun in the U.S. District Court for the Southern District of California on behalf of all persons who purchased or acquired securities of Ligand between Oct. 31, 2003, and Aug. 2, 2004. The complaint alleges that throughout the class period, the defendants failed to disclose and misrepresented material adverse facts, which were "known to defendants or recklessly disregarded by them," including the charge that Ligand had filled the wholesale channel with product in order to show strong demand for its drug Avinza and to meet sales expectations, according to the law firm Bernstein Liebhard & Lifshitz.

• Lorus Therapeutics Inc., of Toronto, presented results Wednesday on a study in metastatic renal-cell carcinoma with GTI-2040 in combination with capecitabine at the EORTC-NCI-AARC meeting in Geneva. Data presented from the ongoing study showed that at the recommended Phase II dose, more than 50 percent of patients with advanced metastatic renal-cell carcinoma showed disease stabilization. Best tumor shrinkages included a 39 percent reduction in a patient with a significant partial response and a 23 percent reduction in a patient who had durable stabilization of disease of 10 months duration. GTI-2040 is an antisense drug that specifically targets the R2 component of ribonucleotide reductase.

• Nanobac Life Science Inc., of Tampa, Fla., completed a private placement that could bring the company $5 million over the next four quarters. The placement was led by the Nutmeg Group, of Northbrook, Ill. Nanobac also said that most of its indebtedness to related parties has been converted to equity at a premium to the current market price, eliminating about $8 million of debt. Nanobac is focused on detecting and eradicating nanobacteria.

• Nanospectra Biosciences Inc., of Houston, received a $2 million award from the Advanced Technology Program of the National Institute of Standards and Technology in Gaithersburg, Md., to develop an integrated approach to the diagnosis and treatment of cancer. The award is expected to fund development of a more accurate cancer-detection method and a minimally invasive treatment using a new class of near-infrared absorbing nanoparticles, called nanoshells.

• Nuvelo Inc., of Sunnyvale, Calif., reported that Phase II results showed the potential of its lead product candidate, alfimeprase, to treat acute peripheral arterial occlusion. Full analysis of the study, NAPA-1, revealed that alfimeprase showed potential for thrombolysis with rates of up to 76 percent and restoration of arterial flow with rates of up to 60 percent based on intent-to-treat analysis. The results were presented Thursday at the Cardiovascular Research Foundation's 16th annual Transcatheter Cardiovascular Therapeutics Scientific Symposium in Washington.

• OSI Pharmaceuticals Inc., of Melville, N.Y., reported that the FDA accepted for filing and review the new drug application for Tarceva as a monotherapy in advanced non-small-cell lung cancer patients for whom chemotherapy has failed. The acceptance of the NDA, as well as Basel, Switzerland-based F. Hoffmann-La Roche Ltd.'s earlier filing of a European marketing application, satisfies milestone provisions for payments totaling $10 million to OSI by Genentech Inc., of South San Francisco, and Roche.

• Perlegen Sciences Inc., of Mountain View, Calif., was awarded a grant by the National Human Genome Research Institute in Bethesda, Md., to support the International HapMap Project. Perlegen will genotype more than 2.25 million single nucleotide polymorphisms in 270 samples from four populations being studied in the HapMap Project. The grant award is for about $6 million.

• ProlX Pharmaceuticals Corp., of Tucson, Ariz., said data presented at the EORTC-NCI-AACR symposium in Geneva described the molecular target and antitumor activity of PX-866, a PI-3-kinase at nanomolar concentrations in vitro. The agent by itself provides good antitumor control when delivered either parenterally or orally, and also enhances the activity of radiation and cytotoxic or other molecularly targeted therapies. The National Cancer Institute recently has entered an agreement to collaborate with ProlX on the development of PX-866.

• Raven Biotechnologies inc., of South San Francisco, said preclinical data presented at the EORTC-NCI-AACR Symposium in Geneva showed that greater than 90 percent of colon, stomach and pancreatic patient tumor samples express the RAV12 carbohydrate epitope, as do a lower percentage of endometrial, ovarian, liver, lung and breast tumors. Raven plans to file an investigational new drug application on RAV12 to treat advanced-stage adenocarcinoma later this year. RAV12 is a high-affinity IgG1 chimeric antibody recognizing a primate restricted N-linked carbohydrate epitope expressed on a number of human carcinomas, especially adenocarcinomas.

• Revivicor Inc., of Blacksburg, Va., formerly called PPL Therapeutics Inc., received a $1.8 million grant from the National Institute of Standards and Technology's Advanced Technology Program. The project supported by the grant is focused on the use of Revivicor's platform technologies in gene knockout and somatic cell nuclear transfer to inactivate the antibody-producing genes in pigs, and replacing them with the human equivalents. The pig serves as a bioreactor to make fully human, broad-spectrum, polyclonal antibodies in large volumes in its blood.

• Salmedix Inc., of San Diego, started two new clinical studies, a Phase II trial of SDX-101 for patients with chronic lymphocytic leukemia and a Phase I/II trial of SDX-102 in patients with previously treated brain tumors. The SDX-101 trial has begun enrolling patients in Sweden, Germany and the UK, and soon will begin enrolling in France and Poland. It will enroll 80 patients with CLL, and response rate will be the primary endpoint. The SDX-102 trial is being conducted by the New Approaches to Brain Tumor Therapy, a consortium funded by the National Cancer Institute.

• Sangamo BioSciences Inc., of Richmond, Calif., entered an agreement with LifeScan Inc., a Johnson & Johnson company, providing LifeScan with Sangamo's zinc finger DNA-binding proteins for use in a program to develop therapeutic cell lines as a potential treatment for diabetes. Financial terms of the agreement were not disclosed.

• Tapestry Pharmaceuticals Inc., of Boulder, Colo., is initiating a second in vivo study to establish the dose response for its oligonucleotides in a transgenic mouse model of Huntington's disease. The new in vivo study is designed to further validate the results of previous studies as to the efficacy of Tapestry's oligonucleotides, which might inhibit the aggregation of the huntingtin protein. There are no effective treatments for Huntington's disease, which afflicts about 35,000 people in the U.S. A report describing the discovery of the oligonucleotides is published in the September 2004 issue of the Journal of Molecular Neuroscience.

• Tripos Inc., of St. Louis, expanded its contract with Schering AG, of Berlin, that governs the companies' ongoing discovery informatics collaboration on the Enterprise Chemical Information Management System, which is designed to allow Schering scientists to manage their chemical research plans more efficiently.

• V.I. Technologies Inc., of Watertown, Mass., rescheduled its special meeting of shareholders to vote on proposals related to the company's proposed merger with Panacos Pharmaceuticals Inc., of Gaithersburg, Md. The meeting will be Oct. 13 to allow Vitex time to continue discussions with respect to the financing proposals and the merger. Terms of any financing would be announced in advance of the rescheduled special meeting. (See BioWorld Today, June 4, 2004.)

• VaxGen Inc., of Brisbane, Calif., reported an extension of negotiations with the U.S. government regarding a potential contract for the purchase of the company's anthrax vaccine. In a letter to VaxGen dated Sept. 29, the U.S. Department of Health and Human Services stated that it is the government's intention to award a contract on or before Oct. 15, subject to the successful conclusion of negotiations. The HHS letter asked VaxGen to extend its proposal for providing 75 million doses of its anthrax vaccine candidate.

• Wyeth Pharmaceuticals Inc., a division of Wyeth, of Madison, N.J., said Enbrel received approval in the European Union to treat adults with moderate to severe plaque psoriasis who failed to respond to, or have a contraindication to, or are intolerant of other systemic therapy. The psoriasis approval marks the fifth indication for Enbrel in the EU. The approval was based on data from three randomized, double-blind, placebo-controlled studies that enrolled more than 1,300 adults with plaque psoriasis. Enbrel was discovered by Immunex, which now is a part of Thousand Oaks, Calif.-based Amgen Inc. Amgen and Wyeth co-promote Enbrel in North America.

• YM BioSciences Inc., of Mississauga, Ontario, completed its bought-deal public offering of 6.6 million units at $3.15 per unit for total gross proceeds of $20.8 million. The units were issued to a syndicate of underwriters led by Dundee Securities Corp. and including Canaccord Capital Corp., Sprott Securities Inc., Dlouhy Merchant Group Inc. and Haywood Securities Inc. The common shares underlying the units will be listed and posted for trading on the Toronto Stock Exchange. YM also said it received approval to list its common shares on the American Stock Exchange under the symbol "YMI." The company's common shares will continue to trade on the Toronto and London stock exchanges. (See BioWorld Today, Sept. 15, 2004.)

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