Accelrys Inc., of San Diego, introduced its latest Discovery Studio release: Discovery Studio SeqStore. DS SeqStore is an Oracle-based enterprise solution designed for managing, analyzing and visualizing genomics and proteomics sequence data.
Axcan Pharma Inc., of Mont-Saint-Hilaire, Quebec, said it is conducting a Phase III trial for the Canadian market of 750-mg mesalamine tablets for the oral treatment of ulcerative colitis. The study is expected to be completed in fiscal 2003 and would serve as the basis for a Canadian filing of a supplementary new drug submission, it said.
Bioanalytical Systems Inc., of West Lafayette, Ind., and RenaSci Consultancy Ltd., of Nottingham, UK, formed a drug discovery and development alliance. Bioanalytical Systems provides research services in bioanalytical chemistry, toxicology/pathology, stability studies and early clinical trials. It has an emphasis on central nervous system diseases, diabetes and anti-infectives. RenaSci focuses on drugs for obesity, diabetes, psychiatric and neurological diseases. Further details were not disclosed.
Biolex Inc., of Pittsboro, N.C., signed a research collaboration and development option agreement with Bayer Corp., of West Haven, Conn., to examine the feasibility of producing human plasminogen and an additional undisclosed human therapeutic protein using Biolex's patented Lemna System. Biolex is a plant-based therapeutic protein company.
Cell Therapeutics Inc., of Seattle, said Chugai Pharmaceutical Co. Ltd., of Tokyo, filed a clinical trial notification to begin trials of Xyotax in Japan. Under the terms of the license agreement between CTI and Chugai, CTI will earn a $3 million milestone payment on the acceptance of the CTN filing by the Pharmaceuticals and Medical Devices Evaluation or 30 days after the initial filing, whichever comes first. Xyotax links paclitaxel to a biodegradable polyglutamate polymer.
Corus Pharma Inc., of Seattle, received a $1.7 million grant from Cystic Fibrosis Foundation Therapeutics, the drug discovery and development arm of the Cystic Fibrosis Foundation. The grant will support drug formulation, preclinical and Phase I trials of Corus 1020 (inhaled reformulated aztreonam), an antibiotic designed to treat respiratory infections in cystic fibrosis patients. It is being developed by Salus Pharma, a wholly owned subsidiary of Corus.
Epimmune Inc., of San Diego, was awarded a contract from the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health in Bethesda, Md., with a total potential of $3.5 million over five years. The award is expected to fund research aimed at developing a malaria vaccine and Epimmune will work with investigators at the Naval Medical Research Center. The award is part of the NIAID's Millennium Vaccine Initiative, which aims to develop vaccines for malaria and tuberculosis.
Hybridon Inc., of Cambridge, Mass., said two articles presenting the results of murine cell culture experiments conducted by the company involving the relationships between DNA structures and activation of the immune system were published in the Journal of Medicinal Chemistry and Bioconjugate Chemistry. The articles provide insight into designing immunomodulatory oligonucleotides for specific immunotherapeutic applications, Hybridon said.
InforMax Inc., of Bethesda, Md., and SciTegic Inc., of San Diego, formed an alliance to develop data pipelining and automation products for the bioinformatics market. The products would combine SciTegic's Pipeline Pilot technologies with components from InforMax's Vector family of products. Financial terms were not disclosed.
Keryx Biopharmaceuticals Inc., of Cambridge, Mass., licensed worldwide rights for the manufacturing process of KRX-101 from Opocrin SpA, of Modena, Italy. The product is in Phase III trials. Keryx also received from Alfa Wasserman SpA - a private Italian pharmaceutical company that licensed KRX-101 to Keryx in certain territories, including the U.S. and Japan - authorization to negotiate European and other territorial rights for KRX-101 on its behalf. Keryx now is in a position to negotiate a worldwide licensing agreement for the Phase III development and commercialization of KRX-101 for diabetic nephropathy, it said.
La Jolla Pharmaceutical Co., of San Diego, discussed the design and progress of its Phase I/II trial of LJP 1082 in antibody-mediated thrombosis at the 10th International Congress on Antiphospholipid Antibodies in Sicily, Italy. Twenty-one patients have completed the trial. In a second presentation, the company discussed data confirming that disease-causing antibodies from patients with antibody-mediated thrombosis bind primarily to domain 1 of beta-2 GP1.
The Leukemia & Lymphoma Society, of White Plains, N.Y., awarded a $7 million grant through its Specialized Center of Research program to Irwin Bernstein, head of pediatric oncology research at the Fred Hutchinson Cancer Research Center in Seattle. The research initiative headed by Bernstein is aimed at developing less toxic and more effective immune-based therapies for treating advanced leukemia and lymphoma.
Nabi Biopharmaceuticals, of Boca Raton, Fla., said preliminary results of a Phase I trial of NicVAX (nicotine conjugate vaccine) in 20 volunteers showed a single dose of NicVAX resulted in an immune response and generated nicotine-specific antibodies. NicVAX is conjugated to the carrier protein recombinant exoprotein A.
Nanosphere Inc., of Northbrook, Ill., entered a contract with the U.S. Government Technical Support Working Group to apply Nanosphere's biomolecular detection system to the detection of biological warfare agents in various mediums. Nanosphere will optimize its platform into a field-deployable detection system that will test samples from water sources. Financial terms were not disclosed.
The National Center for Genome Resources in Santa Fe, N.M., in collaboration with the Ohio Agricultural Research and Development Center at Ohio State University, received a National Science Foundation grant for $1.9 million over the next four years. The grant will fund a project to combine the technology of virus-mediated gene expression with genome sequence data to carry out high-throughput functional screening of Phytophthora genes in plants and to identify virulence genes.
The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health in Bethesda, Md., awarded Avencia, of Manchester, UK, and VaxGen Inc., of Brisbane, Calif., contracts designed to spur development of a new anthrax vaccine. The contracts total $22.5 million through fiscal year 2003. The vaccine would be required to provide immunity to inhalation anthrax in three or fewer doses and therefore expected to reduce administration time.
Pharmion Corp., of Boulder, Colo., launched Innohep (tinzaparin sodium injection) in the U.S. and will market the product to hematology and oncology communities. The product is a low-molecular-weight heparin for the treatment of acute symptomatic deep-vein thrombosis with or without pulmonary embolism when administered in conjunction with warfarin sodium. The product is approved in 55 countries. Innohep acquired the rights to the product from Pharmacia Corp., of Peapack, N.J., in June 2001.
ProMetic Life Sciences Inc., of Montreal, along with its joint development partner, Aldevron LLC, of Fargo, N.D., completed the final steps for the commercialization of a family of patented, chromatographic adsorbents called Perfluorosorb, for use in DNA purification. The company said the adsorbents function in a different manner than materials used to remove DNA contaminants, such as RNA, proteins and endotoxins.
QLT Inc., of Vancouver, British Columbia, and its partner, Xenova plc, of Slough, UK, said the FDA granted fast-track status to tariquidar in multidrug resistance in first-line treatment of non-small-cell lung cancer. The product is in two Phase III trials as an adjunctive treatment in combination with first-line chemotherapy for non-small-cell lung cancer patients. An interim safety analysis is planned for mid-2003.
Repligen Corp., of Waltham, Mass., launched SecreFlo, a synthetic version of secretin. SecreFlo is approved for stimulation of pancreatic secretions to aid in the diagnosis of pancreatic exocrine dysfunction, and stimulation of gastrin secretion to aid in the diagnosis of gastrinoma. The product has been granted orphan drug designation.
SIGA Technologies Inc., of New York, and TransTech Pharma Inc., of High Point, N.C., formed a drug discovery collaboration using TransTech's TTP Translational Technology and SIGA's biological targets to seek small-molecule therapeutics for the treatment of infectious diseases and neutralization of potential biowarfare agents. The companies will focus on discovering classes of anti-infectives to treat infectious diseases, including the biowarfare agents smallpox and anthrax. The companies will share costs and any generated revenues.
The American Society of Gene Therapy in Milwaukee said a serious adverse event was observed in the clinical trial of a gene therapy for the X-linked form of severe combined immune deficiency disease. The trial is being performed by Alain Fischer and colleagues at the H pital Necker Enfants Malade in Paris. The FDA has put a hold on similar trials in the U.S. until more is known about the adverse event - one of the subjects in the trial has developed what appears to be a T-cell leukemia-like illness. The society said further investigation is necessary.
Trimeris Inc., of Durham, N.C., closed its public offering of 2.4 million shares of stock at $45.25, bringing the company total net proceeds of about $102.4 million. The offering was conducted by a group of underwriters, led by Morgan Stanley & Co. Inc. and Goldman, Sachs & Co. Co-managers were Lehman Bros. Inc. and Banc of America Securities LLC. The funds are scheduled to be used for clinical development and commercialization of Fuzeon (formerly T-20) and T-1249, to fund research and development, to provide working capital and for general corporate purposes. Fuzeon's new drug application has been filed with the FDA and a similar submission has been made in Europe. (See BioWorld Today, Sept. 30, 2002.)
Vaxin Inc., of Birmingham, Ala., said its trial with a topically applied recombinant vaccine showed the product can produce an immune response in humans similar to what was observed in animal studies. In the trial, an influenza vaccine was applied to the skin of 18 participants and the vaccine produced a response typical of a successful vaccination, Vaxin said. Additional tests are planned.
VizX Labs LLC, of Seattle, introduced GeneSifter.Net, a platform-independent, web-based microarray analytical software system customizable for data collection and management. The product is designed to enable scientists to load data from microarray image files, scanners or sensors into a VizX-developed database.