Active Biotech AB, of Lund, Sweden, said its application for the initiation of the Tumor Targeted Superantigens pancreas cancer Phase II study was approved by the Medical Control Agency in the UK. In December, the company started a renal cancer Phase II study with Robert Hawkins at Christie Hospital in Manchester, UK. Hawkins also will be the principal investigator for the pancreas cancer study. The study will run for 12 months, and dosing of the 20 patients is expected to begin this quarter.
Albany Molecular Research Inc., of Albany, N.Y., broke ground on the addition of two new, multipurpose Good Manufacturing Practices manufacturing suites at its corporate headquarters. These suites are designed for the synthesis of bulk active pharmaceutical ingredients, suitable for administration to humans, after formulation into appropriate dosage forms. The expansion is in response to growing demand for cGMP synthesis. The company currently operates four cGMP suites.
AltaRex Corp., of Waltham, Mass., reported statistically significant and consistent results from its ongoing analysis of its OvaRex Phase IIb trial in metastatic ovarian cancer by taking into account predefined prognostic factors for early relapse. The company said the results, when combined with four additional prospective trials and retrospective data from a total of more than 500 OvaRex-treated patients will support approval on an accelerated basis. The company in the past two weeks first reported negative results from the study, then said a re-analysis led to the conclusion it did reach statistical significance. (See BioWorld Today, Jan. 28, 2002, and Feb. 1, 2002.)
Antex Biologics Inc., of Gaithersburg, Md., said the U.S. Army Medical Research Institute of Infectious Diseases agreed to test some of the company’s antibiotic compounds as potential drugs to be used against bioterrorism. The Army will perform various tests and laboratory assays to determine if Antex’s lead antibiotic and other compounds are potent against fighting anthrax infections and diseases caused by Bacillus anthracis. The Army’s work under the agreement is scheduled to start immediately. Financial terms were not disclosed.
BioEnterprise Corp., of Cleveland, is looking to raise $60 million $35 million of it earmarked for the purchase and expansion of office and incubator facilities to make Northeast Ohio a national center for biosciences commercialization. The funds also will allow the organization to pursue additional bioscience commercialization and business development opportunities as they are identified.
BioMarin Pharmaceutical Inc., of Novato, Calif., signed a definitive agreement to acquire all of the outstanding shares of Glyko Biomedical Ltd., of Toronto. Glyko’s principal asset is a 22 percent ownership interest in the capital stock of BioMarin. Under the terms of the agreement among BioMarin, Glyko Biomedical and a Canadian subsidiary of BioMarin, Glyko Biomedical’s common shareholders will be entitled to receive 11,367,617 shares of BioMarin in exchange for the acquisition of all outstanding shares of Glyko Biomedical by the BioMarin subsidiary. The number of BioMarin shares outstanding will not change. BioMarin said the move will help the liquidity of its stock.
Cell Therapeutics Inc., of Seattle, said it identified and validated a novel target for anticancer therapy, an enzyme known as lysophosphatidic acid acyltransferase-beta (LPAAT-beta), which is required for the activity of a cancer-causing gene named the ras oncogene. This oncogene is believed to be involved in at least 50 percent of all tumor types, including cancers of the lung, colon, pancreas and brain, the company said. CTI also found that LPAAT-beta is highly expressed by tumor endothelial cells, which suggests that suppressing LPAAT-beta might have anti-angiogenic effects.
Cortex Pharmaceuticals Inc., of Irvine, Calif., said its board approved the adoption of a stockholder rights plan under which all stockholders of record as of the close of business Feb. 15 will receive a distribution of rights to purchase shares of a newly authorized series of preferred stock. The rights become exercisable in the event that a tender offer for the company is announced, or an acquirer purchases at least 15 percent of Cortex’s common stock.
Corvas International Inc., of San Diego, said it expanded the number of potential targets for anticancer drug discovery from an emerging gene family of membrane-bound serine proteases. The company also said it advanced the testing of potent, specific small-molecule inhibitors of matriptase, one of several potential protease targets, into experimental models of late-stage, human prostate cancer. The company also planned to report at a conference progress in cloning the genes of 27 cancer-associated membrane-bound serine proteases and the first data showing the antitumor effects of a small-molecule inhibitor of matriptase.
Demegen Inc., of Pittsburgh, and DFB Pharmaceuticals Inc., of San Antonio, executed a letter of intent granting DFB an exclusive period for evaluation of Demegen’s D2A21 and an option to obtain an exclusive license worldwide. If DFB approves of the evaluation’s results, the companies expect to enter an exclusive worldwide license for topical dermatological applications. DFB will fund additional evaluations designed to determine antimicrobial activity of D2A21 and additional pharmacological characteristics during the exclusive period. Research has shown that D2A21 also is effective against multidrug-resistant strains of Staphylococcus aureus and Pseudomonas aeruginosa, Demegen said.
Endovasc Ltd. Inc., of Montgomery, Texas, said the FDA recommended a split Phase III protocol that would simultaneously evaluate Liprostin in two different patient populations with peripheral arterial occlusive disease based on severity. This provides a separate indication for the vast population of patients suffering from moderate to severe but not ischemic effects of the disease, a much larger group than originally requested. Liprostin had been denied orphan drug status by the Office of Orphan Products Development after refusing to consider the one-year incidence of critical limb ischemia (CLI), and instead basing its decision on a population beyond those patients with late-stage CLI.
Gilead Sciences Inc., of Foster City, Calif., said the European Medicines Evaluation Agency granted marketing authorization for Viread (tenofovir disoproxil fumarate) in the European Union. Viread is approved in Europe for use in combination with other antiretroviral agents for the treatment of HIV infection in patients experiencing early virological failure. Gilead submitted its marketing authorization application for Viread in May 2001. The product received approval in the United States in October. (See BioWorld Today, Oct. 30, 2001.)
High Throughput Genomics Inc., of Tucson, Ariz., purchased all rights and interest in universal array intellectual property and tangible assets from Genometrix Inc., of The Woodlands, Texas. High Throughput said the purchase complements its generic array intellectual property, strengthening and broadening its patent position.
Immunitor Co., of Bangkok, Thailand, said an open-label trial of V-1 Immunitor was published in the January-February issue of HIV Clinical Trials. The paper states that HIV-positive patients given the experimental oral HIV vaccine showed evidence of clinical benefit. Also, Immunitor said that V-1 Immunitor has been given to more than 50,000 AIDS patients in Thailand. Beyond V-1 Immunitor, the company develops immune-based treatments for cancer, microbial and fungal diseases.
Iomed Inc., of Salt Lake City, and Santen Pharmaceuticals Co. Ltd., of Osaka, Japan, are terminating their collaboration despite studies showing that Iomed’s noninvasive ophthalmic drug delivery OcuPhor System was able to deliver an anti-angiogenic drug to the retina and choroid in quantities within a therapeutic range. While the studies demonstrated that the drug, when delivered via subconjunctival injection, achieved the desired anti-angiogenic effect in an animal model, Santen decided the therapeutic index was too low for the drug to be considered for further development. OcuPhor is a drug delivery technology for the noninvasive, site-specific delivery of drug via the transscleral route of administration.
NeoGenesis Pharmaceuticals Inc., of Cambridge, Mass., decreased its price range for its initial public offering from between $12 and $14 to between $9 and $10 per share. The company filed for its IPO on Nov. 16, estimating the total proceeds to be $115 million. NeoGenesis focuses on discovering small-molecule drugs on a proteome- and genome-wide scale. (See BioWorld Today, Nov. 20, 2001.)
Prima Biomed Ltd., of Melbourne, Australia, said its subsidiary, Arthron Ltd., reported interim results indicating one of its compounds demonstrated activity by inhibiting the development of rheumatoid arthritis in mice. Prima Biomed specializes in immunology and cancer immunotherapy and adopts technology development that has commercialization potential.
Epoch Biosciences Inc., of Bothell, Wash., completed agreements that expand distribution of several of the company’s reagents for DNA probes to researchers in world markets. Glen Research Corp., of Sterling, Va., a provider of specialty chemicals for DNA synthesis, will distribute Epoch’s Redmond Red and Yakima Yellow fluorphores, Eclipse Non-Fluorescent Quencher, and PPG modified base worldwide for end users for research purposes. Eurogentec SA, of Liege, Belgium, will use Epoch’s Yakima Yellow dye and Eclipse Non-Fluorescent Quencher to produce custom oligonucleotides for sale in Europe through both its direct sales force and distributors, and in Japan through its joint venture with Nippon Gene Co. Ltd. Financial details were not disclosed.
Northwest Biotherapeutics Inc., of Bothell, Wash., said its investigational new drug application for DCVax-Brain, its dendritic cell-based immunotherapy, was reviewed by the FDA. The company expects to begin a 90-patient Phase II trial with the product in the United States this quarter. Its lead DCVax product, DCVax-Prostate, is entering a pivotal Phase III trial in prostate cancer. Northwest focuses on discovering, developing and commercializing immunotherapy products that use immune system responses to treat cancer.
Nymox Pharmaceutical Corp., of Maywood, N.J., reported private placements with existing shareholders totaling $550,000, at prices between $3.90 and $4.05 per share. The funds are for general corporate purposes, the company said. Nymox developed AlzheimAlert, a urine test that can help in the diagnosis of Alzheimer’s disease, as well as NicAlert and NicoMeter saliva and urine tests for tobacco exposure.
Orchid BioSciences Inc., of Princeton, N.J., and Thermo Electron Corp., of Waltham, Mass., signed a series of technology agreements to develop and market next-generation genotyping products for research and pioneering SNP-based point-of-care diagnostic tests. Orchid obtains nonexclusive rights from the Thermo BioStar division to develop, supply and sell genotyping products for the research market combining Orchid’s SNP-IT genotyping and Thermo BioStar’s OIA and thin-film biosensor technologies. In addition, Orchid and Thermo BioStar agreed to jointly develop and market SNP-based diagnostic products for the point-of-care marketplace.
Oxford GlycoSciences plc, of Oxford, UK, opened a U.S. office in Bridgewater, N.J. The facility will be the center of the company’s focus on specialty biopharmaceuticals in the U.S. Don DeGolyer, who recently was appointed president of global therapeutics, will be based in both the UK and U.S. and will spearhead these activities internationally.
Scil Biomedicals GmbH, of Martinsried, Germany, said enrollment in its Phase II trial with the Smart (humanized) Anti-L-Selectin Antibody in trauma patients is completed. Preliminary results are expected in June. Scil Biomedicals has licensed rights from Protein Design Labs Inc., of Fremont, Calif., to market and manufacture Anti-L-Selectin in trauma and nontrauma indications in Scil’s territories, the company said.
Titan Pharmaceuticals Inc., of South San Francisco, initiated a Phase II study that will evaluate combination therapy with two of its monoclonal antibodies, CeaVac and TriAb, for the treatment of Dukes’ D colorectal cancer in patients with resected liver metastases. The Cancer and Leukemia Group B, a clinical research group, is conducting the trial with funding provided by the National Cancer Institute. About 60 percent of patients with Dukes’ D colorectal cancer develop hepatic metastases. CeaVac and TriAb trigger the immune system to recognize and attack targeted cancer cells, the company said.
Transgenomic Inc., of Omaha, Neb., and the Max Planck Institute for Molecular Genetics, of Berlin, entered a multiyear collaboration to develop a high-throughput genetic variation discovery system. Funded by the German National Genome Research Network (NGFN) and incorporating Transgenomic technology, the system will provide a better tool to attack large-scale genetic variation studies. Such studies are essential for developing associations between genetic variation and diseases. Terms were not disclosed.
Tripos Inc., of St. Louis, said that LION bioscience AG, of Heidelberg, Germany, sold its entire holding of 812,182 shares of Tripos common stock in a block trade transaction handled by UBS Warburg LLC, of New York. Due to the transaction, the public float of Tripos increased from approximately 7.6 million shares to approximately 8.4 million shares, the company said. LION liquidated its entire investment in Tripos, and its rights under an investor rights agreement, including the right to designate a director, have terminated.
ViroLogic Inc., of South San Francisco, reported an agreement with Achillion Pharmaceuticals Inc., of New Haven, Conn., to use ViroLogic’s drug-resistance assays to evaluate Achillion’s lead product candidate, ACH-126,443 (Beta-L-Fd4C), an L-nucleoside in clinical development for the treatment of hepatitis B and HIV. Achillion will use ViroLogic’s assays to evaluate its pipeline of investigational antiviral agents. Achillion currently is evaluating Beta-L-Fd4C in chronically infected HBV patients in a Phase Ib/II trial. Additional Phase II studies are planned for this year to evaluate the drug in both chronic HBV and HIV patients. Financial terms were not disclosed.
ViroPharma Inc., of Exton, Pa., and Aventis Pharmaceuticals, the U.S. pharmaceutical company of Aventis Pharma AG, of Frankfurt, Germany, said the new drug application for Picovir (pleconaril), for the treatment of viral respiratory infection in adults, is scheduled to be reviewed by the Antiviral Drugs Advisory Committee of the FDA on March 19. ViroPharma submitted the NDA for Picovir in July 2001. In September, ViroPharma and Aventis signed an agreement to co-develop and co-promote Picovir in the United States. (See BioWorld Today, Aug. 1, 2001.)