¿ Agenix Ltd., of Sydney, Australia, signed a nonexclusive license agreement with Immunomedics Inc., of Morris Plains, N.J. The agreement gives Agenix access to Immunomedics¿ technology covering the labeling of antibodies with the radioisotope technetium. Immunomedics¿ technology is a one-step method for radiolabeling the Thromboview humanized antibody. The technology allows for the Agenix antibody to be supplied in a stable and active form, ready to be linked to the technetium radiolabel when a patient with a potential thrombosis arrives at a hospital.
¿ Alliance Pharmaceutical Corp., of San Diego, said the 1-5 reverse stock split approved at its annual shareholders meeting became effective Thursday, with trading beginning on a post-reverse split basis.
¿ Caprion Pharmaceuticals Inc., of Montreal, opened a large-scale protein analysis facility, which is the first of its kind in the world, the company said. The 54,000-square-foot, C$31 million (US$19.7 million) facility has been designed and purpose-built for work in proteomics. In the facility housing corporate offices, research laboratories and a data processing center, Caprion uses its subcellular proteomics discovery platform, CellCarta, to generate biological insights into a variety of diseases and to create pharmaceutical products.
¿ Cell Therapeutics Inc., of Seattle, received a recommendation for approval from the Committee for Proprietary Medicinal Products for Trisenox injection in the treatment of relapsed/refractory acute promyelocytic leukemia, a severe and life-threatening form of blood cancer. The European Commission designated the arsenic trioxide product an orphan drug in October 2000. Trisenox was approved by the FDA in 2000. (See BioWorld Today, Sept. 27, 2000.)
¿ Curis Inc., of Cambridge, Mass., said the FDA granted Stryker Corp., of Kalamazoo, Mich., humanitarian device exemption status for Curis¿ regenerative product, OP-1. The approved indication is for use as an alternative to autograft in recalcitrant long-bone nonunions where use of autograft is unfeasible and alternative treatments have failed. Stryker reported that commercial launch of the OP-1 (osteogenic protein) implant in the U.S. is expected to begin later this quarter. The approval marks the third regulatory clearance for OP-1, following approvals earlier this year in Australia and the European Union for specific trauma indications.
¿ Genaissance Pharmaceuticals Inc., of New Haven, Conn., initiated its second clinical study, STRENGTH II (Statin Response Examined by Genetic HAP Markers), to extend its efforts in developing new therapeutic approaches to lowering cholesterol. The studies are designed to link Genaissance¿s markers of human gene variation, HAP markers, to clinical response for the development of diagnostic and therapeutic products. A total of 150 male and female volunteers ranging from 18 to 75 years old with a diagnosis of Type IIa or IIb hypercholesterolemia will be enrolled at 45 sites nationwide. Separately, Genaissance said it has filed a universal shelf registration to offer and sell common stock, preferred stock, debt or warrants to purchase common stock, preferred stock or debt, up to a value of $35 million.
¿ Gilead Sciences Inc., of Foster City, Calif., said the European Union¿s Committee for Proprietary Medicinal Products recommended granting marketing authorization for Viread (tenofovir disoproxil fumarate) in the 15 member states of the European Union. The recommendation was for treating HIV in patients 18 years and older experiencing early virological failure. Gilead said it expects the authorization will be granted in early 2002. An FDA advisory panel earlier this month recommended approval of the product. (See BioWorld Today, Oct. 4, 2001.)
¿ ID Biomedical Corp., of Vancouver, British Columbia, announced positive results from the expanded human testing of its intranasally administered prototype influenza vaccine. This trial is examining the safety of the vaccine and the immune response it produces in 100 healthy adults. The vaccine is being tested using various dosing regimens.
¿ IntegraGen, of Evry, France, said it signed a number of scientific collaborations that will enhance its access to high-quality family collections required to drive its gene discovery activities. Deals were signed with the German universities of Marburg and Heidelberg. IntegraGen¿s collaboration with the University of Marburg is complementary to an ongoing program: the Obesity Consortium, part of the German Human Genome Project. The deal with the University of Heidelberg will allow IntegraGen to develop a Type II diabetes family collection, for which it will hold exclusive access rights.
¿ Introgen Therapeutics Inc., of Houston, said an abstract describing a preclinical study using its product candidate INGN 251 (adenoviral-PTEN) to inhibit the growth of vascular smooth muscle cells was published in Circulation. The studies showed that treatment with INGN 251 inhibited the growth of animal smooth muscle cells by as much as 70 percent. Introgen said the PTEN gene is important for diagnosis and treatment of cancer and hyperproliferative diseases such as arterial disease and rheumatoid arthritis. Introgen is the exclusive licensee of this gene from Imperial Cancer Research Technology Ltd. in the UK.
¿ MGI Pharma Inc., of Minneapolis, and Methylgene Inc., of Montreal, presented data on the role of DNA methyltransferases in cancer at a conference titled Epigenetics of Cancer, sponsored by the American Association of Cancer Research in Palm Desert, Calif. The first presentation highlighted the ability of MG98, a second-generation antisense oligonucleotide, to demethylate and re-express certain tumor suppressor genes and DNA repair genes in human colorectal tumor cell lines. The study demonstrated that the enzyme, DNA methyltransferase-3b, is a key regulator responsible for maintaining aberrant DNA methylation in human cancer cells. The second presentation demonstrated that specific targeting of DNA methyltransferase-3b can result in demethylation and re-expression of tumor suppressor genes and induce programmed cell death in human tumor cells.
¿ Microbiotix Inc., of Worcester, Mass., was awarded a Phase I Small Business Innovation Research grant by the National Institute of Allergy and Infectious Disease to expand its antibiotics screening operation. The grant will provide more than $220,000 for a six-month period ending March 31, 2002, to support the discovery and characterization of novel antibiotics that selectively inhibit bacterial DNA replication, accelerating efforts to develop new drugs to confront the growing crisis of antibiotic-resistant bacterial infections.
¿ Nastech Pharmaceutical Company Inc., of Hauppauge, N.Y., raised about $5.8 million through a private sale of 1.1 million shares of common stock. Dain Rauscher Wessels acted as exclusive placement agent for the offering, which included the following institutional investors: Safeco Growth and RST Opportunities Fund, MPM Capital BioEquities Fund, Perceptive Life Sciences Fund and RS Investments Growth Fund. The financing, coupled with a cash position of approximately $7.1 million as of Sept. 30, provides further financial support to accelerate multiple development programs, including the completion of Phase II trials for intranasal apomorphine for the treatment of erectile dysfunction and female sexual dysfunction, it said.
¿ Phylonix Pharmaceuticals Inc., of Cambridge, Mass., received a Phase II Small Business Innovation grant from the National Institutes of Health to develop a rapid predictive assay for organ toxicity drug screening using zebrafish embryos. The amount was not disclosed.
¿ Regeneration Technologies Inc., of Alachua, Fla., received a three-year, $2 million award from the National Institute of Standards and Technology¿s Advanced Technology Program to start development of an allograft-based gene delivery system for improving bone regeneration. RTI is collaborating with scientists at Carnegie Mellon University in Pittsburgh to develop a process that will accelerate the rate of bone regeneration in patients who need repair of significant bone defects.
¿ RHeoGene LLC, of Charlottesville, Va., was awarded a three-year, $2 million grant from the National Institute of Standards and Technology¿s Advanced Technology Program for engineering systems targeting site-specific alteration in mammalian genomes. This award will expand RHeoGene¿s core technology base and drive development of new applications in the areas of drug discovery, cell-based therapeutics, functional genomics and tissue engineering. With the funding, the company plans to improve gene-targeting technology by creating precise, highly efficient gene editing tools, referred to as engineered enzymes, to direct the insertion and deletion of gene sequences in nuclear and mitochondrial genomes. Advancing gene-targeting technology also will enhance the development of new applications for RHeoGene¿s RHeoSwitch gene regulation platform.
¿ Ribozyme Pharmaceuticals Inc., of Boulder, Colo., began a multicenter Phase II trial of Heptazyme for the treatment of patients with chronic hepatitis C. Heptazyme is a direct antiviral therapeutic specifically engineered to target HCV and has shown potent antiviral activity in preclinical models. The study is designed to evaluate Heptazyme safety and efficacy when administered alone and in combination with interferon.
¿ Sangamo BioSciences Inc., of Richmond, Calif., said it reached a milestone in its strategic alliance with Edwards Lifesciences Corp., of Irvine, Calif., to use gene regulation to treat cardiovascular disease. Sangamo delivered to Edwards a lead zinc finger DNA-binding protein therapeutic product candidate designed to activate the vascular endothelial growth factor gene, which resulted in a payment to Sangamo of $1.4 million.
¿ SurroMed Inc., of Mountain View, Calif., and Applied Biosystems Group, of Foster City, Calif., an Applera Corp. business, were awarded a three-year, $8 million grant from the National Institute of Standards and Technology Advanced Technology Program. The grant is for the development of SurroMed¿s nanoscale technology and Applied Biosystems¿ multiplexing chemistry capabilities for DNA analysis. SurroMed expects about $3.7 million of the funding, and Applied Biosystems expects about $4.3 million.
¿ Telik Inc., of South San Francisco, reported that the underwriters of its recent follow-on public offering exercised their option to purchase 600,000 additional shares to cover overallotments. That brings the total offering to 4.6 million shares at $6.50 per share, or $29.5 million. The offering was made through an underwriter group led by Lehman Brothers Inc., with Legg Mason Wood Walker Inc., UBS Warburg LLC, Lazard Freres & Co. LLC and Needham & Company Inc. co-managing the offering. (See BioWorld Today, Aug. 21, 2001, and Oct. 1, 2001.)
¿ Transgene SA, of Strasbourg, France, reported the initiation of a Phase II trial of its immunotherapeutic MVA-HPV-IL2 product candidate for the treatment of cervical cancer to induce an efficient immune response and to produce an antitumor effect. The trial will include up to 57 women with varying stages of HPV 16 cervical cancer that either is resistant to radiotherapy or has recurred after radiotherapy. The two-stage trial will be conducted in Mexico, and will evaluate the efficacy of multiple subcutaneous injections. The first stage will involve an interim analysis performed once 22 evaluable patients have been reviewed at six months post-treatment. If at least five patients respond, the study will recruit 35 additional patients for a second stage. Transgene¿s candidate uses the MVA virus to express two HPV antigens, the E6 and E7 proteins.