Amgen Inc., of Thousand Oaks, Calif., and Wyeth Pharmaceuticals, a division of Wyeth, of Madison, N.J., initiated what they said is the largest clinical trial to date to evaluate the impact of a tumor necrosis factor inhibitor in patients with rheumatoid arthritis in the U.S. It is the second phase of a 10,000-patient study known as Radius and will compare the safety, efficacy and treatment patterns of 5,000 RA patients treated with Enbrel with that of 5,000 patients treated with a variety of disease-modifying anti-rheumatic drugs (DMARD) in the first phase. Radius will evaluate patients who meet American College of Rheumatology criteria for RA and who require a change or addition of a new DMARD. Enbrel will be used in eligible patients either as monotherapy or in addition to the patient's current DMARD treatment. Enbrel, a fully human, soluble TNF receptor, is the only biologic approved for the first line treatment of RA.
Centocor Inc., of Malvern, Pa., said it has a newly expanded research and development platform that will center on the discovery and application of therapies to treat immune-mediated inflammatory disorders. A company officer said Centocor "is committed to identifying the molecular targets that trigger these disorders and to develop new biopharmaceutical therapies, particularly monoclonal antibodies," to improve the lives of patients with such diseases. Research and development efforts will include the exploration of common immune pathways shared by seemingly unrelated diseases with the goal of developing new therapies. The platform builds on the company's success with Remicade, a tumor necrosis factor alpha therapy that is the only biologic approved to treat both rheumatoid arthritis and Crohn's disease.
Discovery Laboratories Inc., of Doylestown, Pa., and CollaGenex Pharmaceuticals Inc., of Newtown, Pa., entered a research collaboration to evaluate the combination of their platform technologies for the development of respiratory disease therapeutics. The companies will collaborate on the preclinical evaluation of an aerosolized formulation of Discovery's humanized lung surfactants combined with CollaGenex's Impacs (Inhibitors of Multiple Proteases and Cytokines) compounds. Diseases for which the companies will seek therapeutics are chronic obstructive pulmonary disease, cystic fibrosis, chronic interstitial lung disease and acute lung injury. Terms were not disclosed.
ECI Biotech Expressive Constructs Inc., of Worcester, Mass., which specializes in research and development of new protein technologies, said it launched an incubator program that will assist fledgling biotechnology companies through the start-up period by allowing them to lease space within ECI's laboratories. That also will give them access to equipment, ECI said.
Generex Biotechnology Corp., of Toronto, said Health Canada approved an investigational new drug application to begin clinical trials of buccal fentanyl for the treatment of pain. The approval follows the completion earlier this year of successful proof-of-concept studies of fentanyl delivered systemically through the buccal cavity. Fentanyl is a synthetic narcotic agonist analgesic with actions similar to morphine but much more potent and less prolonged, Generex said.
Genomatica Inc., of San Diego, received a Small Business Innovation Research grant from the U.S. Department of Energy to develop a metabolic model of Pseudomonas fluorescens, a soil bacterium used in both the degradation of hazardous waste such as petroleum and crude oil compounds and toxic metals and in the protection of agricultural crops from disease. The aim of the model is to aid the use of P. fluorescens for toxic waste degradation and improve the bacterium's functionality in agricultural pathogen control.
Innogenetics NV, of Ghent, Belgium, reported the first histology results of its E1-based therapeutic candidate vaccine in 24 patients chronically infected with hepatitis C virus genotype 1. Following previously announced Phase II results, an open-label study extension was initiated in the spring of 2002. The study involved 34 patients who completed the initial study and subsequently re-enrolled, although most had previously failed to respond to current standard treatment. On completion of the extension, the overall Ishak histology score either improved or remained stable for 79 percent of patients. A histological improvement was seen in 38 percent of patients.
International Therapeutics Inc., of Seattle, entered into a research collaboration with City of Hope National Medical Center in Duarte, Calif., to evaluate and characterize small interfering RNA molecules against HIV. The siRNAs are short antisense oligonucleotides that exert their effect by causing messenger RNA degradation and, in turn, inhibit protein production. International Therapeutics and the medical center will co-own the intellectual property resulting from the collaboration. ITI has the option to license the joint technology.
Introgen Therapeutics Inc., of Austin, Texas, and its collaborators at the M.D. Anderson Cancer Center in Houston had a preclinical study published in Clinical Cancer Research. The researchers discovered that mebendazole, a drug used to treat parasitic infections, shows activity against human lung cancer cells. The study showed that the drug kills malignant human lung cancer cells, without toxicity to normal cells. When administered to mice bearing human lung tumors, mebendazole inhibited the growth of the tumors and reduced their number and size. Introgen acquired worldwide rights to the drug, which is still in preclinical development.
Nabi Biopharmaceuticals, of Boca Raton, Fla., signed two international distribution agreements for Nabi-HB (hepatitis B immune globulin) with Biotech Medical Corp., of Malaysia, and Innovative Biotech PTE, a corporation of the Republic of Singapore. Biotech Medical and Innovative Biotech will import finished Nabi-HB manufactured in Nabi's Boca Raton plant and will coordinate the regulatory approval process for registration of the product with the Malaysia and Republic of Singapore ministries of health, respectively. Once approved, the companies will sell and distribute Nabi-HB in those markets.
Nexell Therapeutics Inc., of Irvine, Calif., said its board adopted a plan to liquidate and dissolve the company. Based on current information, the company expects a cash distribution to common stockholders, which will exclude Baxter Healthcare Corp., of Deerfield, Ill., and its affiliates. Although the company said it is unable to predict the precise timing of such distribution, it hopes to make it by year's end. On May 15, the board authorized management to begin immediately an orderly windup of operations, and several options were considered since, including dissolution under Delaware law, liquidation or reorganization under the federal bankruptcy code. The company was delisted from the Nasdaq at the start of business on Sept. 3. (See BioWorld Today, May 16, 2002.)
Praxis Pharmaceuticals Inc., of Vancouver, British Columbia, reported that Pharmaxis Pty. Ltd., of Canberra, Australia, is completing Phase II trials of Pharmaxis' cystic fibrosis and chronic obstructive pulmonary disease therapeutics. Pharmaxis is a research and development company in which Praxis has a significant shareholding, the company said.
Quark Biotech Inc., of Cleveland, a private biotechnology company focusing on drug development, located its corporate headquarters in the center of the campus of The Cleveland Clinic Foundation. As part of a multiyear agreement, Quark and the clinic also will share resources.
Select Therapeutics Inc., of Boston, said the American Stock Exchange issued a halt trading order on its stock. The company said the proximate cause for the action is that the company is late in filing its 10-KBS for the previous fiscal year, because it currently lacks the resources to prepare and make the filing. Select Therapeutics said it is beginning discussions with AMEX representatives to determine how the company may return its stock to trading status.
Sequenom Inc., of San Diego, sold two additional MassArray systems to GlaxoSmithKline plc, of London. The sales follow an initial MassArray system purchase by GSK earlier this year. The system is Sequenom's technology platform for analysis of genetic variation.
The Immune Response Corp., of Carlsbad, Calif., reported the final results of a study at McMaster University Health Sciences Centre in Hamilton, Canada, suggesting that use of Remune antigen in combination with oligonucleotides containing immunostimulatory CpG motifs induces HIV-specific immune responses in genital and vaginal tracts and protected animals from infection after virus challenge. The study was published in The Journal of Infectious Diseases.
The Multiple Myeloma Research Foundation in New Canaan, Conn., said a team of researchers from The Johns Hopkins University School of Medicine in Baltimore is the recipient of its 2002 Collaborative Program Grant. The grant, which provides $1.5 million to researchers over a three-year period, is designed to foster collaborations among researchers and institutions to help bring new therapies quickly to the clinic.
Transgenomic Inc., of Omaha, Neb., and PXE International entered a collaboration to develop a diagnostic test for the genetic condition, pseudoxanthoma elasticum, commonly known as PXE. The intent is to develop a test based on Transgenomic's WAVE System and make it available to laboratories around the world.
Vion Pharmaceuticals Inc., of New Haven, Conn., said it would appeal Nasdaq's determination to delist Vion's stock from The Nasdaq National Market by requesting a hearing before a Nasdaq Listing Qualifications Panel. Vion received notification from Nasdaq Tuesday that its common stock would be delisted from the market because it did not comply with Nasdaq's minimum bid price requirements.
Xenogen Corp., of Alameda, Calif., entered an agreement with Millennium Pharmaceuticals Inc., of Cambridge, Mass., under which Millennium will obtain access to Xenogen's real-time in vivo imaging technology platform for its oncology program. Millennium also will purchase Xenogen's IVIS Imaging System and Living Image software package. Millennium has options to purchase Xenogen's Bioware cells and microorganisms and LPTA animal models. Terms were not disclosed.