• Agennix Inc., of Houston, said preclinical data to be published in the Sept. 1, 2004, issue of the International Journal of Cancer point to the anticancer activity of rhLF, a natural immunomodulatory protein. An oral version demonstrated that activity when administered alone and in combination with chemotherapy in tumor-bearing mice. Monotherapy of a squamous-cell carcinoma in a syngeneic murine model caused a 66 percent tumor growth inhibition, which was statistically significant compared to placebo and comparable to that obtained by therapy with cisplatin, docetaxel or radiotherapy. Mice receiving both rhLF and cisplatin showed a statistically significant improvement over either drug alone. Tumor growth inhibition with oral rhLF also was observed in a murine renal-cell carcinoma model. In a mammary adenocarcinoma model, oral rhLF also induced tumor shrinkage, including complete rejection of established tumors.

• Antares Pharma Inc., of Exton, Pa., named Jack Stover CEO and appointed him a director, in addition to his prior duties as the company's president and chief operating officer. The move follows the resignation of Roger Harrison as CEO, though he will remain a consultant. Prior to joining Antares, Stover was executive vice president and chief financial officer at Sicor Inc., of Irvine, Calif.

• Aphton Corp., of Miami, said its board adopted a stockholder rights plan. In connection with the plan, the board also declared a dividend of one preferred stock purchase right for each outstanding common share. Each of the rights, which currently are not exercisable, entitle the holder to purchase one-thousandth of a share of the company's newly designated Series A Junior Participating Preferred Stock. Aphton, which is developing targeted immunotherapies for cancer and other diseases, said the move is not in response to any specific effort to acquire control of the company.

• Bioenvision Inc., of New York, said its board approved the decision to switch the listing of its common stock from the American Stock Exchange to the Nasdaq National Market. Effective Friday, the cancer drug development company's shares will trade on the Nasdaq exchange under the symbol "BIVN."

• Biogen Idec Inc., of Cambridge, Mass., and Elan Corp. plc, of Dublin, Ireland, applied for Canadian approval of Antegren (natalizumab) as a treatment for multiple sclerosis, and they expect to follow later this year with applications in Australia and Switzerland. The companies also expect to release one-year data from ongoing Phase III trials upon FDA approval, which could come in November. The unveiling of the data will be about a month later than first expected, as the partners initially planned to release the one-year findings at a scientific meeting in October, but they said the delay protects the two-year trials' integrity. The companies, which expect two-year data to be available in the first half of next year, filed in May for FDA approval, a few months after reporting plans for the application. (See BioWorld Today, Feb. 19, 2004.)

• Biomax Informatics AG, of Martinsried, Germany, and Siemens AG, of Munich, Germany, entered an alliance for gene-expression modeling and simulation. Siemens' BioSim product, which recognizes interrelated dependencies within gene-expression data, will produce correlations to be placed in a functional and biological context using the Biomax BioXM Gene Expression Analysis Tool.

• BioPort Corp., of Lansing, Mich., said the FDA accepted its investigational new drug submission related to its anthrax vaccine. The acceptance allows proof-of-concept studies in humans for an immune-stimulating molecule to be added to BioPort's FDA-licensed BioThrax vaccine. The company said the addition of the molecule, if demonstrated to be safe and effective, could potentially reduce the number of doses of BioThrax required to reach and maintain a protective level of immunity against B. anthracis infection. Research to evaluate the immune system impact of the molecule will be funded by the Defense Advanced Research Projects Agency.

• Bio-Rad Laboratories Inc., of Hercules, Calif., completed its $32 million cash purchase of MJ GeneWorks Inc., of Waltham, Mass. The agreement also included the assumption of certain liabilities of MJ and its subsidiaries, including liabilities related to certain patent-infringement litigation to which MJ Research Inc. is a party, plus a cash earn-out based on the outcome of such litigation. MJ Research specializes in instruments and consumables used in biological research, including thermal cycling instrumentation and reagents used to amplify DNA, while Bio-Rad manufactures life science research products and clinical diagnostics.

• Bioxel Pharma Inc., of Sainte-Foy, Quebec, issued to Investissement Quebec warrants to purchase about 688,000 common shares at C51 cents (US39 cents) apiece for a period of five years following their issuance. The warrants were issued in consideration of a loan made by Investissement Quebec to the company, which manufactures naturally derived taxanes and develops targeted oncology drugs.

• Bolder BioTechnology Inc., of Wheat Ridge, Colo., was awarded a $749,898 Phase II Small Business Innovation Research grant from the National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health in Bethesda, Md. The company said it would use the funds to optimize a second-generation beta interferon candidate for clinical development, and develop a manufacturing process for the product. The research is centered on developing a long-acting beta interferon for multiple sclerosis.

• Cell Genesys Inc., of South San Francisco, began a Phase I/II trial of CG7870, an oncolytic virus therapy for prostate cancer, administered in combination with docetaxel (Taxotere). The multicenter study was prompted by encouraging results from a previous Phase I/II trial of CG7870 as a single agent in metastatic hormone-refractory prostate cancer, and preclinical studies have shown significant synergistic antitumor activity when CG7870 was used in combination with the chemotherapy agent. The dose-escalation study is expected to enroll up to about 70 patients with metastatic hormone-refractory prostate cancer who have not received prior chemotherapy. A second treatment phase will enroll up to 30 patients from the multidose group after a maximum dose has been identified.

• Eyetech Pharmaceuticals Inc., of New York, received a $10 million milestone payment from Pfizer Inc., also of New York, after the FDA accepted their new drug application for Macugen (pegaptanib sodium injection) for neovascular age-related macular degeneration. The agency also said it would review the submission on a priority basis. Based on the priority-review designation, the FDA has six months from the submission date to take action on the filing. The partners submitted the final portion of their rolling application two months ago under the FDA's fast-track designation, and the agency and its Dermatologic and Ophthalmic Drugs Advisory Committee will review Macugen on Aug. 27. (See BioWorld Today, June 18, 2004.)

• Gene Logic Inc., of Gaithersburg, Md., expanded its European and Asia-Pacific operations as a result of revenue growth in those areas. The company added sales and support staff to its London office, Gene Logic Ltd., and also hired a business development representative who will be based in Germany. In addition, it established Gene Logic KK as a wholly owned subsidiary in Japan to provide marketing and customer support there. Gene Logic said 14 percent of its total revenue for the period ended June 30 resulted from pharmaceutical and biotechnology companies based in Europe, with 33 percent coming from Asia Pacific.

• Generex Biotechnology Corp., of Toronto, said its wholly owned subsidiary, Antigen Express, established a collaboration with Massachusetts General Hospital in Boston to use modified peptide antigens to stimulate immunity to HIV for both prevention and treatment of HIV infection. The collaboration brings together an HIV research program at the hospital, identifying optimal targets for peptide vaccines, and technologies developed at Antigen Express. Financial terms were not disclosed.

• Gilead Sciences Inc., of Foster City, Calif., said it would provide access to Truvada (emtricitabine and tenofovir disoproxil fumarate) through its global access program and advancing access program. The global access program, which began in April 2003, will offer the AIDS product at no profit in 68 countries, including every country in Africa and 15 additional underdeveloped countries. Through its advancing access program, Gilead will offer Truvada to patients in the U.S. who cannot obtain reimbursement or afford to pay for the product. Truvada, which combines the active ingredients of Emtriva (emtricitabine) and Viread (tenofovir disoproxil fumarate) into one tablet, received FDA approval earlier this month. (See BioWorld Today, Aug. 4, 2004.)

• Icon Genetics AG, of Munich, Germany, entered a collaborative agreement to evaluate the expression levels and quality of preclinical pharmaceutical proteins belonging to Berlex Inc., the U.S. affiliate of Schering AG, of Berlin. Icon will test their expression in transgenic plants using its magnICON biomanufacturing platform technology, which provides a method for producing therapeutic and other recombinant proteins using non-genetically modified organism, non-food plants as production hosts. Financial terms were not disclosed.

• MedImmune Inc., of Gaithersburg, Md., began dosing patients in a Phase I trial of an anti-interleukin-9 (IL-9) monoclonal antibody. The move triggered a $500,000 milestone payment to Genaera Corp., of Plymouth Meeting, Pa. The companies' agreement dates to April 2001, when they entered a collaboration and licensing deal to co-develop an IL-9-based treatment for asthma. Data from preclinical studies in models of asthma suggest that IL-9-neutralizing antibodies might help reduce airway hyper-reactivity, mucous production and inflammation. MedImmune is evaluating the molecule as a potential treatment for symptomatic, moderate to severe persistent asthma.

• Novavax Inc., of Columbia, Md., clarified two S-3 registration statements filed last week to register shares in connection with its repurchase of worldwide rights to Estrasorb and related financings that were announced last month. The Estrasorb transaction and related financings added about $23 million to Novavax's balance sheet to support the topical estrogen therapy's launch and related sales force expansion. Shares registered in the filings were only those shares previously disclosed, and no additional shares were registered. The filings were made to satisfy the company's obligations arising from registration rights granted in the transactions. (See BioWorld Today, July 20, 2004.)

• Nurel Therapeutics Inc., of Pittsburgh, opened laboratory operations in incubator space at the Pittsburgh Life Sciences Greenhouse. The company is developing products to treat and manage pain and peripheral nerve damage, and is expanding into vascular disease.

• Paradigm Genetics Inc., of Research Triangle Park, N.C., changed its name to Icoria Inc. to reflect its evolution into an integrated systems biology company. It is changing its business from a functional genomics company serving the agrichemical sector to a company conducting product-focused discovery and development research in both health care and agriculture.

• Predix Pharmaceuticals Inc., of Woburn, Mass., said findings published in the Aug. 3, 2004, issue of the Proceedings of the National Academy of Sciences illustrate the company's repeated success in using computerized 3-dimensional models of GPCR drug targets for blind in silico screening. The article details data that show that the Predict methodology achieved identification of high-quality hits, including lead compounds, directly out of the in silico screening for multiple drug discovery programs, all using Predix's computer-generated GPCR structures. By integrating the computational technology with standard medicinal chemistry, Predix has created several programs and recently completed Phase I studies with its most advanced compound. Additional data will be reported in the Oct. 1, 2004, issue of Proteins.

• Senetek plc, of Napa, Calif., said the listing qualifications division of the Nasdaq National Market notified the company of its decision to delist Senetek's American Depository Shares from Nasdaq due to non-compliance with a minimum continued listing standard. Senetek, which is developing anti-aging products, said it intends to appeal the delisting decision.

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