• Access Pharmaceuticals Inc., of Dallas, began a Phase I study to evaluate AP5346, a DACH polymer platinate. The study, which is being conducted in France and the Netherlands, is designed to establish the maximum tolerated dose to be administered in future clinical studies. Upon successful completion of the Phase I study, a Phase IIa study will be conducted in ovarian cancer patients to determine the initial efficacy of AP5346.

• Applied Biosystems Group, of Norwalk, Conn., an Applera Corp. business, said the U.S. District Court for the District of Connecticut dismissed all claims brought against it by On-Line Technologies Inc., of East Hartford, Conn. On-Line, which also sued PerkinElmer Inc., of Boston, and Sick AG, of Waldkirch, Germany, charged the companies with patent infringement and trade secret misappropriation, among other things, related to products manufactured by former divisions of Applied Biosystems sold to the co-defendants.

• Biosyn Inc., of Huntingdon Valley, Pa., acquired from the National Institutes of Health in Bethesda, Md., exclusive, worldwide rights to develop and commercialize a protein called cyanovirin-N as an HIV microbicide. Biosyn said cyanovirin-N has shown potent anti-HIV activity in laboratory studies and in animal models, adding that it expects to develop the compound as a microbicide to prevent sexual transmission of HIV.

• Biotech Holdings Ltd., of Richmond, British Columbia, filed with the Toronto Stock Exchange Venture Exchange for issuance of 10 million warrants, at C10 cents each. The warrants are to be issued to creditors who agreed to extend the time for repayment of about C$3.1 million (US$2.1 million) of loans issued to Biotech Holdings.

• Celmed BioSciences Inc., a subsidiary of Theratechnologies Inc., of Montreal, said it is decreasing its early stage discovery staff and increasing its clinical development personnel as it plans to intensify efforts in its two technological platforms. Theralux, which is in Phase I/II trials, is designed for certain cancers, while Neuro is designed to treat Parkinson's disease.

• Centocor Inc., of Malvern, Pa., a unit of Johnson & Johnson, of New Brunswick, N.J., said the FDA approved Remicade (infliximab) for reducing the number of draining enterocutaneous and rectovaginal fistulas and for maintaining fistula closure in patients with fistulizing Crohn's disease. Centocor said up to 30 percent of the estimated half-million Americans with Crohn's disease have fistulas, which are openings that extend through the bowel wall into nearby organs or through the surface of the skin. Remicade is the only biologic drug indicated for both Crohn's disease and rheumatoid arthritis.

• CollaGenex Pharmaceuticals Inc., of Newtown, Pa., received Canadian regulatory approval for Periostat (doxycycline capsules 20mg). Its Canadian licensing partner, Pharmascience Inc., of West Conshohocken, Pa., will be responsible for all Periostat sales and marketing activity north of the border. CollaGenex will receive royalties on Canadian Periostat sales, along with milestones upon achievement of unspecified commercial objectives.

• Corautus Genetics Inc., of San Diego, formed two months ago through a merger of Vascular Genetics and GenStar Therapeutics, laid off 15 employees as part of its restructuring plan to boost efficiency and reduce burn. Corautus, which completed manufacturing of VEGF-2 for a Phase IIb trial expected to begin in this year's second half, said it expects to outsource additional manufacturing needs for a Phase III trial and eventual commercialization. But such production requirements are not expected until at least next year. Corautus added that it is pursuing financing, as well as partnering discussions with potential collaborators for various capacities on the upcoming trial. Separately, Robert Sobol resigned his positions of president and director in order to pursue other interests. (See BioWorld Today, Sept. 16, 2002.)

• Cytokine PharmaSciences Inc., of King of Prussia, Pa., entered an agreement to exclusively license U.S. rights to its second-generation cervical ripening product to Integrity Pharmaceutical Corp., of Indianapolis. Cytokine, which will receive an undisclosed up-front payment, milestones and royalties, will manage all clinical work before a new drug application is filed, while Integrity will share such expenses.

• Draximage Inc., the radiopharmaceutical division of Draxis Health Inc., of Mississauga, Ontario, began U.S. shipments of its recently approved radiotherapeutic product, a kit for the preparation of sodium iodide I-131 capsules and oral solution. The product, indicated for both thyroid cancer and hyperthyroidism, have been supplied to the Nuclear Pharmacy Services group of Cardinal Health Inc., of Dublin, Ohio.

• Elusys Therapeutics Inc., of Pine Brook, N.J., reported data at the International Conference on Anthrax in Nice, France, showing that its heteropolymer product to remove anthrax toxin from the bloodstream works in animals. Elusys said data also demonstrate that its technology can take antibodies that may be harmful on their own and make them beneficial. The anthrax heteropolymer, which consists of one monoclonal antibody that targets the anthrax toxin linked to a second monoclonal antibody that attaches to a receptor on red blood cells, is designed to remove the toxin from the bloodstream even after symptoms appear and buy time for later-stage antibiotic treatment.

• Epigenomics AG, of Berlin, closed a €21 million Series C round of financing. Epigenomics said it would use the funds to further develop its diagnostic products in cancer and its pharmacodiagnostic and research products, to pursue different disease indications and for general corporate purposes. Since its 1998 inception, Epigenomics has raised more than €56 million. The latest round included new investor The Wellcome Trust Ltd., of London, as well as all existing venture capital investors, including 3i Group and Abingworth, both of London; Deutsche Venture Capital DVC, of Munich, Germany; MPM Capital, of Boston; and tbg, of Bonn, Germany.

• Genelabs Technologies Inc., of Redwood City, Calif., said a Johns Hopkins University researcher presented data on its investigational drug Prestara (prasterone) at a joint meeting of the British Society for Rheumatology and the Societe Francaise de Rhumatologie. Findings indicated that in women with active systemic lupus erythematosus (SLE, or lupus), Prestara improved or stabilized overall SLE disease activity and symptoms without deterioration. In the primary data set for analysis, Prestara patients with an SLE Disease Activity Index score greater than 2 at baseline showed a 59 percent rate of response compared to 45 percent for placebo (p=0.017). Additional analyses showed that Prestara patients showed better response rates compared to placebo as well. The drug, which is called Anastar in Europe, prevented bone loss in SLE patients receiving prednisone, a glucocorticoid drug. Genelabs' stock (NASDAQ:GNLB) rose 24 cents Thursday, or 18.1 percent, to close at $1.57.

• Genencor International Inc., of Palo Alto, Calif., said its board named Jean-Jacques Bienaime chairman after accepting W. Thomas Mitchell's resignation. Bienaime retains his titles of president and CEO, which he assumed in November after Mitchell stepped down from those positions as well. The board also elected Jorgen Rosenlund, group general counsel of Danisco A/S, to fill the vacancy created by the retirement of another member, Juha Kurkinen.

• Genome BioSciences Inc., of Temecula, Calif., agreed to a two-year extension of its agreement with Chemicon International Inc., also of Temecula, for the co-marketing of mouse knockout and knock-in services. Both parties will continue to co-market contract services to nonprofit and industrial markets through November 2007. Financial terms were not disclosed.

• Geron Corp., of Menlo Park, Calif., reported data at the From Stem Cells to Therapy Keystone Symposium in Steamboat Springs, Colo., showing engraftment of human embryonic stem cell (hESC)-derived dopaminergic neurons transplanted into the brain of a rat model of Parkinson's disease and the production of pure populations of hESC-derived cardiomyocytes. Geron also described studies that defined the properties and biological stability of hESCs over long-term culture.

• Human BioSystems, of Palo Alto, Calif., said it was modifying its preservation solution designed to extend the shelf life of blood platelets, a decision that should resolve delays in clinical research first reported in November. Formerly called Hyperbaric Systems Inc., the company said it discovered that alternative ingredients improved results. The company originally contracted with a U.S. blood research center to begin human infusion studies before the end of last year.

• Hybridon Inc., of Cambridge, Mass., added its HYB2055 product, a second-generation immunomodulatory oligonucleotide, to its clinical pipeline as its investigational new drug application became effective. Hybridon, which called the product the first compound developed from its immunomodulatory therapeutic program, said HYB2055 has shown potent Th-1 biased immunomodulatory activity in preclinical models. A Phase I study of its safety and immunological activity in healthy volunteers is under way, and a Phase I cancer trial is scheduled to begin soon as well.

• ImmuCell Corp., of Portland, Maine, said its board approved a plan to repurchase up to 100,000 shares of its common stock in open-market transactions, private transactions, or otherwise. The maximum shares represent about 3.7 percent of its outstanding common stock as of March 31. ImmuCell said it plans to hold any repurchased shares as treasury stock to be used for general corporate purposes.

• Johnson & Johnson, of New Brunswick, N.J., said the U.S. Federal Trade Commission terminated the Hart-Scott-Rodino Antitrust Improvements Act of 1976 waiting period in its bid to purchase Scios Inc., of Sunnyvale, Calif. The cash-for-stock transaction is expected to close, subject to satisfaction of closing conditions, as soon as possible following a Scios stockholder meeting scheduled for April 28. (See BioWorld Today, Feb. 11, 2003.)

• Martek Biosciences Corp., of Columbia, Md., filed with the Securities and Exchange Commission a preliminary prospectus supplement to its recently filed shelf registration statement relating to a proposed underwritten offering of 2.815 million common shares consisting of 2.5 million offered by the company and 315,000 by a selling stockholder. Salomon Smith Barney; Adams, Harkness & Hill Inc.; and Needham & Company Inc. are managing the offering.

• Metabasis Therapeutics Inc., of San Diego, said Ribapharm Inc., of Costa Mesa, Calif., began clinical testing of Hepavir B. An orally active, liver-specific prodrug of the antiviral agent adefovir, Hepavir B was developed by Metabasis and licensed in October 2001 to Ribapharm, which a year later filed an investigational new drug application for the product.

• MethylGene Inc., of Montreal, said it would publish Phase I results in the May 1, 2003, issue of Annals of Oncology showing that MG98 is well tolerated, has produced evidence of objective tumor response or disease stabilization in cancer patients and has predictable human pharmacokinetics. The solid tumor study was conducted by the National Cancer Institute of Canada.

• MichBio, Michigan's biosciences industry association located in Ann Arbor, named Michael Witt executive director. Witt, who previously was CEO of Technology Enterprise Development Corp., a medical technology development company in Sacramento, Calif., and Flint, Mich., is responsible for steering the growth of the association throughout the state.

• PhotoCure ASA, of Oslo, Norway, said its Metvix PDT product received Australian regulatory approval to treat actinic keratosis, an early form of skin cancer. The company also reported that a 229-patient, multicenter, European Phase III study showed Metvix PDT to be efficacious in treating early squamous cell carcinoma. The product showed a 93 percent complete response rate compared to 86 percent for cryotherapy and 83 percent for topical chemotherapy. Metvix PDT patients also reported a 59 percent improvement in cosmetic outcomes, compared to 30 percent for cryotherapy and 45 percent for topical chemotherapy.

• Pure Protein LLC, of Oklahoma City, and the Canadian Network for Vaccines and Immunotherapeutics (CANVAC) said Pure Protein was accepted as a member of CANVAC. The network is comprised of 74 Canadian scientists specializing in the fields of immunology, virology and molecular biology.

• Rigel Pharmaceuticals Inc., of South San Francisco, received a second undisclosed milestone payment from Daiichi Pharmaceuticals Co. Ltd., of Tokyo, in conjunction with their partnership to develop an oncology drug. The companies are investigating a target derived from ligases. The collaboration began in August, although financial terms were not disclosed. (See BioWorld Today, Aug. 13, 2002.)

• St. Jude Children's Research Hospital in Memphis, Tenn., said scientists developed a vaccine against H5N1, an influenza virus that appeared in birds in Hong Kong late last year and then killed one of two infected people with rapidly progressive pneumonia in the past month. It said it developed it in four weeks, after receiving the H5N1 sample from Hong Kong.

• SuperGen Inc., of Dublin, Calif., said decitabine, one of its cancer compounds, will now be called Dacogen. The product recently completed enrollment in a randomized Phase III study in myelodysplastic syndrome. The company raised $21.25 million in a notes offering in February. (See BioWorld Today, Feb. 28, 2003.)

• Symyx Technologies Inc., of Santa Clara, Calif., and Houston-based Univation Technologies LLC, a joint venture between The Dow Chemical Co. and Exxon Mobil Chemical Co., entered a multiyear agreement to discover polymer catalysts for Univation's polyethylene licensing business. Univation will fund Symyx' discovery efforts and has exclusive rights to commercialize materials discovered within the field of the collaboration. Symyx will receive royalties in connection with the license of any products commercialized.

• Targeted Genetics Corp., of Seattle, reported data from its AIDS vaccine preclinical program at the annual Keystone AIDS Vaccine Conference in Banff, Alberta. In studies presented, Targeted Genetics and collaborators demonstrated that using a recombinant adeno-associated virus-based HIV vaccine resulted in antibody and T-cell immune responses in nonhuman primates. Data presented from safety studies in animals support the safety of the vaccine, called tgAAC09, the company said. Human trials are targeted to begin later this year.

• Tm Bioscience Corp., of Toronto, introduced its early access program designed to allow a select group of medical institutions and testing labs access to the company's genetic tests. Tm will provide a limited number of hospitals, academic institutions and genetic testing centers with Tag-It genetic tests for evaluation purposes.

• The Whitehead Institute/MIT Center for Genome Research in Cambridge, Mass., publicly released a draft genome sequence of the mold Aspergillus nidulans, a fungus used to study genetics and cell biology. The sequencing represents the first of a number of fungal sequencing projects supported by the National Human Genome Research Institute as part of the Fungal Genome Initiative. The sequence is available at http://www.genome.wi.mit.edu/

• Xcyte Therapies Inc., of Seattle, began a 35-patient, U.S.-based Phase I/II trial to study the safety of its Xcellerated T Cells in multiple myeloma patients who have undergone high-dose chemotherapy and a stem cell transplant. Data also will be collected to assess the biologic and therapeutic activity of the product, which are T cells produced using Xcyte's Xcellerate Technology.

• Zonagen Inc., of The Woodlands, Texas, said its board authorized the repurchase of up to $2.5 million of common stock from time to time. It has about 11.5 million shares outstanding. The company focuses on pharmaceutical products for the reproductive system. Its stock (NASDAQ:ZONA) rose 20 cents Thursday, or 16.7 percent, to close at $1.40.