¿ American Financial Holding Inc., of Farmington, Utah, said it acquired Isolagen Technologies Inc., of Houston, in a stock-for-stock transaction. Along with the merger, American Financial raised more than $2 million in an equity private placement of common stock and converted $1.45 million principal amount of Isolagen debt and approximately $625,000 of accrued liabilities to equity. The money will be used to fund Isolagen¿s research and development projects, to fund FDA trials, to explore the viability of entering foreign markets, and for additional working capital and general corporate purposes. Isolagen is developing an autologous cellular system for hard- and soft-tissue regeneration and other therapies.
¿ Antex Biologics Inc., of Gaithersburg, Md., released results from its Phase Ib clinical trial of Helivax, the company¿s vaccine intended to prevent and treat gastrointestinal infections and disease caused by Heliobacter pylori. The company said that Phase Ib results continue to show the vaccine to be safe and immunogenic. Similar to the results of the Phase Ia trial, the vaccine stimulated mucosal antibody responses that correlate with protection against infection and disease. Additional analyses of cellular immune responses are under way. The company currently is preparing for a Phase II trial.
¿ Biomira Inc., of Edmonton, Alberta, and Merck KgaA, of Darmstadt, Germany, said they will meet with the FDA to review the regulatory strategy of the cancer vaccine, Theratope. The meeting is expected to take place in early October. The Theratope vaccine Phase III trial is progressing as planned, Biomira said, and all 1,030 patients were enrolled in March.
¿ British Biotech plc, of Oxford, UK, initiated a share award plan for all its employees, designed to provide incentives to reach the company¿s objectives and increase shareholder value over the next three years. Employees, including executive directors, have been granted options to more than 12.3 million shares.
¿ Cambridge Antibody Technology plc (CAT), of Melbourn, UK, released early results from its Phase II clinical trial using CAT-152 in patients undergoing surgery for glaucoma. CAT-152 is designed to prevent excessive post-operative scarring. The randomized, placebo-controlled study included 56 patients. The company reported that CAT-152 was found to be safe and well tolerated with no serious drug-related adverse events, and no severe injection site reactions were reported. Intraocular pressure was lowered more in the drug group than in the control group.
¿ Demegen Inc., of Pittsburgh, received up to $1.5 million in support from the Cystic Fibrosis Foundation Therapeutics Inc., the drug development affiliate of the Cystic Fibrosis Foundation, of Bethesda, Md., to investigate an antimicrobial agent called P113D to treat lung infections in people with cystic fibrosis (CF). The funding will assist Demegen in completing preclinical development of P113D, filing an investigational new drug application and evaluating the safety and efficacy of the treatment in CF patients.
¿ Galapagos Genomics NV, of Leiden, the Netherlands, formed a research collaboration with Vertex Pharmaceuticals Inc., of Cambridge, Mass. Galapagos will provide through its PhenoSelect expression platform custom-based recombinant adenoviruses for protein targets of interest to Vertex¿s small-molecule drug design efforts. Vertex will use the collection of adenoviruses to characterize protein activity within targeted biological pathways. Terms were not disclosed.
¿ Genomics Collaborative Inc. (GCI), of Cambridge, Mass., reported signing agreements with five biopharmaceutical companies including Pharmacia Corp., of Peapack. N.J., GlaxoSmithKline plc, of London, and Exelixis Corp., of South San Francisco, for GCI Access. GCI Access is designed to provide researchers with access to the company¿s proprietary database of clinical data and DNA, tissue and sera samples collected from more than 100,000 patients. According to the company, GCI Access enables researchers to accelerate the validation process by accessing large numbers of matched case to control populations in multiple disease states.
¿ Gilead Sciences Inc., of Foster City, Calif., said that Viread, its investigational agent for the treatment of HIV infection, is scheduled to be reviewed by the Antiviral Advisory Committee of the FDA on Oct. 3. The company submitted a new drug application on May 1. The priority review classification Gilead received should allow for action by the FDA by Nov. 1, the company said.
¿ Image-Guided Neurologics Inc. (IGN), of Melbourne, Fla., and Peregrine Pharmaceuticals Inc., of Tustin, Calif., have agreed to co-sponsor a Phase I/II pilot study of Cotara, Peregrine¿s tumor necrosis therapy drug, using IGN¿s Navigus Array multi-lumen intracranial catheter in patients with brain cancer. The study is designed to further characterize flow and distribution characteristics of the Array catheter when used with Cotara, as well as to better understand methods to improve overall distribution of the drug at the tumor site. Approximately six patients will be enrolled.
¿ PerkinElmer Inc., of Boston, said it acquired a 10 percent equity interest in Kibron Inc., of Helsinki, Finland. PerkinElmer will have exclusive global distribution rights, excluding Japan, to all of Kibron¿s future life science products and will have the option to acquire control of Kibron. Separately, PerkinElmer signed an agreement to serve as the global distributor of the Progenesis software platform, developed and produced by Nonlinear Dynamics Ltd. Progenesis, which automates and accelerates the major time-limiting step in the proteomics workflow, the company said, will be offered as part of PerkinElmer¿s integrated proteomics solution.
¿ Q3DM Inc., of San Diego, raised $1.5 million in its Series A round of financing. The financing was led by Aztec Venture Network LLC, of San Diego, and California Tech Coast Angel, of Laguna Hills, Calif. The proceeds will be used to complete current efforts for the commercialization of assays through strategic collaborations and to assemble a consortium of pharmaceutical companies to refine the instrumentation and assay development. Also, the funds will be used to broaden Q3DM¿s software development and biology teams.
¿ Quark Biotech Inc., of Cleveland, said Taisho Pharmaceutical Co. Ltd., of Tokyo, has made an equity investment in the company. The investment was made as part of QBI¿s Series F financing. The companies currently are collaborating on scientific research projects to discover the genes that cause kidney disease and to develop a therapeutic treatment. Terms of the investment were not disclosed.
¿ Quintiles Transnational Corp., of Research Triangle Park, N.C., and Novia Pharmaceuticals Ltd., of Tel Aviv, Israel, formed an alliance to provide preclinical services for Novia¿s lead AD4 compound to treat central nervous system disorders. Novia will subcontract all preclinical work on the project to Quintiles¿ Early Development and Laboratory Services in Edinburgh, Scotland. Quintiles, through its PharmaBio Development group, will make an investment in Novia and will receive an equity position and royalties.
¿ SciClone Pharmaceuticals Inc., of San Mateo, Calif., reported completing enrollment for its Phase III monotherapy hepatitis trial in Japan with Zadaxin, its lead immune system enhancer drug. The randomized, double-blind study involves more than 300 patients with chronic hepatitis B infection, and is designed with a six-month treatment period followed by a 12-month evaluation. The final patients now are receiving the six-month therapy, and the majority of the patients already have completed therapy and follow-up.
¿ Scios Inc., of Sunnyvale, Calif., said it began filling orders for and shipping Natrecor to U.S. hospitals. The company received FDA approval to market Natrecor in the U.S. last week. Natrecor is the first in a class of new drugs called human B-type natriuretic peptides (hBNP) to be made available as a therapeutic for human disease. The drug is a recombinant form of hBNP, a natural protein found in the body. (BioWorld Today, Aug. 14, 2001.)
¿ Sequitur Inc., of Natick, Mass., agreed to provide to Rigel Pharmaceutical Inc., of South San Francisco, access to Sequitur¿s antisense functional genomics technology. The multiyear agreement stipulates a supply of Sequitur¿s antisense compounds, sequence selection and transfection methods will go to Rigel and that collaborative research will be performed at Sequitur. Rigel will pay research support, antisense material charges and licensing fees.
¿ Thermo Finnigan Inc., of San Jose, Calif., a division of Thermo Electron Corp., and Proteome Systems Inc., of Sydney, Australia, partnered to develop total solutions for proteomics research. Proteome Systems will augment its integrated proteomics technology system, ProteomIQ, by incorporating several Thermo Finnegan products. Thermo Finnigan will have access to Proteome Systems¿ sample preparation technology for the electrospray mass spectrometer.
¿ XenoPharm Inc., of San Diego, said it will evaluate developmental compounds for Bristol-Myers Squibb Co., of New York, using proprietary assays. Bristol-Myers will provide an unspecified number of compounds and XenoPharm will test the ability of the compounds to induce the expression of drug metabolism enzymes typically found in the liver. Terms were not disclosed.