• AcroMetrix Corp., of Benicia, Calif., signed an agreement with Ambion Diagnostics, a division of Austin, Texas-based Ambion Inc., to manufacture RNA-based products, and distribute them to in vitro diagnostic laboratories. The agreement is based on Armored RNA technology, a system jointly developed by Ambion and Cenetron Diagnostics Ltd., also of Austin, for the packaging of RNA in bacteriophage coat proteins to protect and stabilize RNA.

• Advanced Biotherapy Inc., of Woodland Hills, Calif., said preliminary results of a Phase I trial of an investigational treatment for AIDS patients who have failed to respond to standard antiretroviral drugs appeared to show a beneficial effect by inhibiting tumor necrosis factor-alpha (TNF-alpha). The company said the study's purpose was to determine whether inhibiting overproduction of TNF-alpha and other cytokines, such as interferon-gamma and subtypes of interferon-alpha, was implicated in stimulating viral replication. Advanced Biotherapy will release further results after all the data have been analyzed.

• AEterna Zentaris Inc., of Quebec City, decided its Japanese partners, Shionogi & Co. Ltd. and Nippon Kayaku Co. Ltd., should push ahead with the development of cetrorelix, a luteinizing hormone-releasing hormone antagonist, in the benign prostate hyperplasia indication. The decision followed an earlier announcement by Solvay Pharmaceuticals Inc., of Marietta, Ga., which serves as AEterna's worldwide (excluding Japan) exclusive development and marketing partner for cetrorelix, for conducting a Phase III development program in endometriosis as a primary indication. Cetrorelix, AEterna's lead drug in the class of LHRH antagonists, has completed seven Phase II trials in endometriosis, BPH and uterine myoma.

• AnorMED Inc., of Vancouver, British Columbia, initiated enrollment in a Phase Ib/IIa trial to evaluate the potential of AMD070, an oral CXCR4 HIV entry inhibitor, in HIV-infected patients. The company's clinical program for AMD070 is being conducted by leading investigators at the U.S. Adult AIDS Clinical Trials Group, which is supported by the National Institute of Allergy and Infectious Diseases at the National Institutes of Health.

• Biogen Idec Inc., of Cambridge, Mass., and the FDA revised a warning label for Avonex (interferon beta-1a) to caution that rare cases of severe hepatic injury, including hepatic failure, have been reported in patients taking the multiple sclerosis drug. Asymptomatic elevation of hepatic transaminases also has been reported, and in some patients has recurred upon re-challenge. In some cases, those events occurred in the presence of other drugs associated with hepatic injury. The potential risk of Avonex used in combination with known hepatotoxic drugs or other products such as alcohol should be considered prior to Avonex administration, the revised label said, or when adding new agents to the regimen of patients already on Avonex, which the FDA approved in 1996. Health care professionals have been notified of revisions to the product's label. Shares in the company (NASDAQ:BIIB), which less than a month ago pulled its next-generation multiple sclerosis drug, Tysabri (natalizumab), off the market due to safety concerns that surfaced three months after FDA approval, fell 88 cents Wednesday to close at $37.19. (See BioWorld Today, March 1, 2005.)

• BioTrove Inc., of Woburn, Mass., screened more than 1 million individual samples in the last 12 months using the RapidFire Lead Discovery system. The company also signed contracts with a pharmaceutical firm and a biotechnology company, on whose behalf some of the samples were screened. RapidFire Lead Discovery is a mass spectrometry-based service enabling the high-throughput screening of biochemical assays.

• Cellzome Inc., of Boston, entered a collaboration and license agreement with Ortho-McNeil Inc., a subsidiary of New Brunswick, N.J.-based Johnson & Johnson, for Cellzome and Ortho-McNeil's affiliate, Johnson & Johnson Pharmaceutical Research and Development LLC, to collaborate to identify compounds for Alzheimer's disease. Cellzome will receive a technology access fee and research funding for two years, and is eligible for development milestone payments and royalties. Further details were not disclosed.

• Chemokine Therapeutics Corp., of Vancouver, British Columbia, said investigators at the National Cancer Institute reported a two-thirds reduction in the number of visible metastatic lung nodules using the company's investigational drug CTCE-9908 in a preclinical study of osteosarcoma. The company said the results were consistent with a preclinical study conducted by its researchers. CTCE-9908 is designed to inhibit the growth and spread of certain common cancers with the potential for use with other existing therapies, such as chemotherapy, surgery and radiation.

• ChondroGene Ltd., of Toronto, received a contribution from the National Research Council's Industrial Research Assistance Program for the development of a blood-based molecular diagnostic assay to detect early asymptomatic osteoarthritis, as well as the stage of disease severity. ChondroGene will use its Sentinel Principle to identify blood-based biomarkers that are associated with osteoarthritis. Once validated, those biomarkers will form the basis of a diagnostic test.

• Cyclacel Group plc, of Dundee, UK, formed a research collaboration with Altana Pharma AG, a unit of Konstanz, Germany-based Altana AG, in which Cyclacel will use its expertise in mitosis or cell division to identify the molecular targets of specific Altana drugs. Altana will supply Cyclacel with molecules shown to interfere with mitosis.

• Gamida-Cell Ltd., of Jerusalem, appointed Yael Margolin president and CEO. Margolin has been on the board since 2000. Prior to joining Gamida-Cell, Margolin served as the vice president of Denali Ventures. Gamida-Cell is focused on the expansion of hematopoietic stem cell therapeutics in clinical development for cancer.

• Gilead Sciences Inc., of Foster City, Calif., said its global access program for HIV medicines is being expanded to include additional countries in the Caribbean and Latin America. The program makes Truvada and Viread available to physicians and treatment programs in those countries at no-profit prices. The expansion means that 95 countries, representing an estimated 70 percent of the global epidemic, are included in the access effort.

• GlycoGenesys Inc., of Boston, closed the first tranche of its previously reported $6.5 million private placement, resulting in gross proceeds of $2 million from institutional and accredited investors. Investors purchased 2,000 shares of Series D preferred stock and warrants to purchase 2 million shares of common stock at $1.23 each. In the second closing, the company will issue 4,500 shares of Series D preferred stock and warrants to purchase 4.5 million shares of common stock for gross proceeds of $4.5 million. GlycoGenesys plans to use proceeds primarily for its Phase I/II trial for GCS-100LE, a low ethanol formulation of GCS-100 in multiple myeloma as well as in lymphocytic leukemia; making drug supplies of GCS-100LE for clinical trials; conducting additional analytical and preclinical studies; paying licensing fees; and working capital.

• ImmuneRegen BioSciences, of Scottsdale, Ariz., submitted a formal proposal to include Radilex in the Canadian Defense Ministry's "Universal Protectants Proposal." The goal of the program is to find a universal treatment for chemical, biological, radiological and nuclear threats, such as anthrax or dirty bombs.

• InNexus Biotechnology Inc., of Vancouver, British Columbia, extended and expanded its research and development program for superantibody technology by expanding its R&D facilities within the Kentucky Technology Center on the Coldstream Research Campus in Lexington, Ky. The facility includes equipment for fluorescence flow cytometry analysis, ELISA, a full protein chemistry lab, cell culturing and other infrastructure.

• IntegraGen SA, of Paris, opened its first genetic testing facility in Bonn, Germany. Called the Expert Center, it will provide laboratory testing combined with genetic counseling. The first test to be offered will be for the diagnosis of maturity-onset diabetes of the young.

• Introgen Therapeutics Inc., of Austin, Texas, said data published in a recent issue of DNA and Cell Biology by researchers at Introgen and the University of Texas M.D. Anderson Cancer Center show the potential utility of combining the company's nanoparticle delivery system with the mda-7 gene for the treatment of lung cancer. The delivery system is a component of INGN 401, in Phase I trials for lung cancer, and the mda-7 gene is the active component of INGN 241, in Phase II trials for metastatic melanoma.

• ITX International Holdings Inc., of Mountain View, Calif., exclusively licensed Houston-based GeneExcel Inc.'s liposome drug delivery targeting technology for entrance into the Japanese market. The company invested $700,000 on a milestone basis as part of a $1 million Series A financing of GeneExcel. Alkek Ventures and some private investors joined the round. Joseph Baxter, ITX's scientific analyst, has joined GeneExcel's board.

• Lev Pharmaceuticals Inc., of New York, initiated a Phase III trial to treat hereditary angioedema with its lead orphan drug candidate, C1-esterase inhibitor. The trial is a multicenter, placebo-controlled, double-blind study designed to examine the use of C1-INH in treating acute attacks of angioedema and in preventing the onset of such attacks. Lev is developing the product through an agreement with Sanquin Blood Supply Foundation, which is based in Amsterdam, the Netherlands.

• Medical Discoveries Inc., of Salt Lake City, completed the acquisition of the intellectual property assets of Hamburg, Germany-based Savetherapeutics AG for €2.35 million (US$3.1 million). Savetherapeutics is developing a topical steroidal form of aromatase inhibitor for breast cancer called SaveCream. M.A.G. Capital LLC provided MDI with $3 million for the acquisition.

• Meridian Bioscience Inc., of Cincinnati, said its wholly owned subsidiary, Viral Antigens Inc., entered a distribution agreement with San Diego-based Synbiotics Corp. for the distribution of VAI's veterinary products. Synbiotics immediately will begin marketing VAI's line of Pseudorabies Virus Antibody test kits.

• Novavax Inc., of Malvern, Pa., and Ranbaxy Laboratories Inc., of New Delhi, India, entered an agreement to evaluate a new transdermal product that was formulated using Novavax's micellar nanoparticle technology. While specific terms were not disclosed, Ranbaxy's payment to Novavax includes funding to complete a proof-of-concept study. Upon completion, the companies expect to enter a commercialization and development agreement.

• OncoGenex Technologies Inc., of Vancouver, British Columbia, and Isis Pharmaceuticals Inc., of Carlsbad, Calif., broadened their antisense drug partnership to allow for the development of two additional second-generation antisense cancer drug candidates. OncoGenex has not selected the molecular targets for drug development. The companies initiated the partnership in December 2001 to co-develop OGX-011, which is in Phase I/II development for prostate, breast and lung cancer. It expanded it in 2003 to include OGX-225, which is in the research phase of development.

• Oxford Genome Sciences Ltd., of Oxford, UK, entered a collaboration with Bayer HealthCare AG Diagnostics Division, a member of the Bayer Group, of Leverkusen, Germany. OGeS will apply its proteomics platform, in conjunction with its Oxford Genome Anatomy Project, to evaluate candidate biomarkers that might have applications in clinical care for the diagnosis and prognostic assessment of breast cancer. Bayer Diagnostics committed program funding to OGeS and agreed to performance-related payments upon achieving certain milestones.

• PR Pharmaceuticals Inc., of Duluth, Ga., and Merial Ltd., of Fort Collins, Colo., formed an alliance for the development of animal health products using PRP's sustained-release formulation and manufacturing technologies. Merial, which provides marketing and distribution services for PRP's Durelease to the beef industry, will have exclusive worldwide rights to develop, register, market and distribute other products.

• Sigma-Aldrich Corp., of St. Louis, entered an agreement with the Massachusetts Institute of Technology in Cambridge, Mass., to serve as a scientific collaborator and distribution partner of the RNAi Consortium. The consortium is based at the Broad Institute in Boston.

• Spectrum Pharmaceuticals Inc., of Irvine, Calif., said clinical data were presented at the European Association of Urology Congress in Istanbul, Turkey, from a Phase II marker lesion study with intravesical instillation of EOquin in superficial bladder cancer. The data demonstrate that EOquin is an efficacious treatment in patients with superficial bladder tumors, the company said. Complete disappearance of the tumor as confirmed by biopsy was seen in 71 percent, or 29 out of 41, patients.

• YM BioSciences Inc., of Mississauga, Ontario, said the FDA approved the use of TheraCIM h-R3 as a monotherapy in the treatment of a child with advanced glioma under an investigational new drug application. The company hopes to repeat the clinical success in the U.S. that was achieved in Europe, Canada and Asia. In a Phase II conducted in Germany in children with brain cancer, TheraCIM h-R3 produced an overall response rate of 35.3 percent, with six of 17 evaluable patients demonstrating either stable disease or a partial response.