¿ Antex Biologics Inc., of Gaithersburg, Md., completed preclinical studies on a vaccine to prevent diarrhea caused by Shigella sonnei. The first clinical trial of the vaccine will begin, the company said, this year. The company reported that the vaccine protected 100 percent of animals in a preclinical study against infection and disease.
¿ Ark Therapeutics Ltd., of London, said a Phase I/IIa trial of its gene medicine treatment, EG009, for malignant glioma showed the therapy doubled patient survival time. EG009 treatment is a combination of a herpes simplex virus thymidine kinase gene in a modified adenoviral delivery vector, and ganciclovir.
¿ Array BioPharma Inc., of Boulder, Colo., said it entered a long-term lease at its Boulder headquarters. The new lease will increase its total laboratory space to 190,000 square feet over the next four years. When the expansion is complete Array's facilities will be able to accommodate more than 300 scientists and a total of 400 employees.
¿ Aurora Biosciences Corp., of San Diego, approved a stockholders rights plan. The plan approves the right of stockholders of record as of April 17 to purchase shares of a new series of preferred stock.
¿ Biotica Technology Ltd., of Cambridge, UK, said the University of Cambridge completed sequencing of the bacteria Saccharopolyspora erythraea, which is used in production of the broad-spectrum polyketide antibiotic erythomycin. Biotica will develop industrial applications for erythromycin and related polyketides.
¿ Celgene Corp., of Warren, N.J., said an independent interim analysis of data from the Arkansas Cancer Research Center's Total Therapy II combination multiple myeloma trial of Thalomid, Celgene's FDA-approved treatment for erythema nodosum leprosum, resulted in a continuation of the trial. The ACRC will enroll an additional 300 patients in the trial.
¿ Cardion AG, of Erkrath, Germany, said it will acquire Tolerance Pharmaceuticals Inc., of Boston. Financial terms were undisclosed. Cardion said the acquisition will strengthen its abilities in cell transplantation and build its immunology business. Cardion focuses on gene therapy and stem cell engineering. Tolerance's immunotherapy platform, based on technology developed by company founder Terry Strom, the Beth Israel Deaconess Medical Center chief of immunology, interferes with the interleukin-15-dependent pathway of immune system activation to selectively reprogram the immune system to ignore transplants and auto-antigens.
¿ Cell Therapeutics Inc., of Seattle, said the European Commission granted orphan medicinal product designation for Trisenox (arsenic trioxide) for treatment of multiple myeloma and myelodysplastic syndromes. Trisenox was granted orphan status last year for treatment of promyelocytic leukemia.
¿ Celltech Pharmaceuticals Inc., of Rochester, N.Y., formerly Medeva Pharmaceuticals Inc. and a member of the Celltech Group, said the FDA granted marketing authorization for Metadate CD (methylphenidate HCl) extended-release 20 mg capsules for treatment of attention deficit hyperactivity disorder in patients 6 years or older. The treatment is a biphasic once-daily administration formulated using Eurand International S.p.A.'s Diffucaps technology, and Eurand will receive manufacturing fees and royalties from commercialized Metadate.
¿ De Novo Pharmaceuticals Ltd., of Cambridge, UK, received its second tranche of funding totaling #950,000 (US$1.36 million). The company received its first round of financing in April 2000. De Novo focuses on computational drug design.
¿ Demegen Inc., of Pittsburgh, completed the second stage of an agreement to acquire the majority of assets of Peridontix Inc., of Watertown, Mass. Demegen said it has filed four investigational new drug applications for Peridontix products and will file a fifth this quarter. All the INDs are directed at oral infection treatments.
¿ Gem Pharmaceuticals Inc., of Pelham, Ala., said scientists from the Huntsman Cancer Institute presented Phase I/II data for its anticancer agent GPX-100, an analogue of doxorubicin, to the American Association for Cancer in New Orleans. The company said the maximum tolerated dose was established and there were no signs of cardiotoxicity.
¿ LION Bioscience AG, of Heidelberg, Germany, restructured its San Diego operation to accelerate its integration of the life science informatics expertise gained through the acquisition of Trega Biosciences Inc. LION will make a research and development operation in San Diego to develop predictive software tools for ADME (absorption, distribution, metabolism and excretion).
¿ Lynx Therapeutics Inc., of Hayward, Calif., entered a collaborative research agreement with AstraZeneca plc, of London. The collaboration aims to identify genes that are differentially expressed between different human tissues. The agreement is the second this year between the companies. Lynx will analyze AstraZeneca samples using Megasort technology, its proprietary gene analysis system. Lynx will receive payments from AstraZeneca upon achievement of certain project objectives.
¿ MacroChem Corp., of Lexington, Mass., named Robert Palmisano CEO and president. Palmisano is the former CEO of Summit Autonomous, an ophthalmic laser company.
¿ Nanogen Inc., of San Diego, said it placed three NanoChip Molecular Biology Workstations in the first quarter. Two were nontitle transfers representing development site agreements, and the third, a title-transfer transaction, was recorded as product revenue.
¿ Ortec International Inc., of New York, said the FDA accepted its premarket approval application for Composite Cultured Skin. The company submitted the PMA for the tissue-engineered product in early March.
¿ Paligent Inc., of New York, appointed Salvatore A. Bucci president and CEO. Bucci is the former executive vice president and chief financial officer of Paligent.
¿ Pharmacopeia Inc., of Princeton, N.J., demonstrated its scientific software and technology at the American Chemical Society Meeting in San Diego. The software business formed by the combination of Molecular Simulations Inc., Oxford Molecular Ltd., and Synopsys Scientific Systems Inc., the company said, will operate under the name Accelrys Inc., effective June 1.
¿ Synsorb Biotech Inc., of Calgary, Ontario, retained Omnicare Clinical Research Inc. to provide support and resources for its Phase III trials of Synsorb CD. The master services agreement offers Synsorb services including data analysis, regulatory consulting, regulatory filings in major jurisdictions and general management support for the clinical development program.
¿ Vical Inc., of San Diego, said the FDA reconfirmed that Vical's Phase II and Phase III trial designs would support registration of Allovectin-7 for melanoma. The company expects to complete enrollment in a Phase III trial in the third quarter.
¿ Vion Pharmaceuticals Inc., of New Haven, Conn., filed a shelf registration statement for the sale of up to 5 million shares at the company's discretion. At Tuesday's close of $3.875 the offering would generate gross proceeds of $19.375 million.
¿ ZymeTx Inc., of Oklahoma City, received a determination from Nasdaq that its shares are subject to delisting due to a failure to comply with the net tangible asset requirement for continued listing. The company has requested a hearing before the Nasdaq Listing Qualifications Panel to review the determination. In the event the panel does not grant the company's request for continued listing ZymeTx said it will seek listing on the Nasdaq SmallCap Market.