Aclara BioSciences Inc., of Mountain View, Calif., said the first purchase order for its Arteas technology, formerly referred to as Oasis, was received in December, marking the second milestone in its effort to commercialize the technology. Arteas uses microfluidic technology to decrease total assay volume compared to other high-density screening platforms.
Cell Genesys Inc., of Foster City, Calif., said three of eight patients who received a higher dose of its GVAX pancreatic cancer vaccine in combination with surgery in the initial trial of the vaccine at the Johns Hopkins Oncology Center remained disease-free and alive at 38, 35 and 33 months after diagnosis. The updated results were published in the Journal of Clinical Oncology. The company said the results support its plans to begin a Phase II trial of the vaccine in 60 pancreatic cancer patients this year.
Centocor Inc., of Malvern, Pa., said the FDA gave marketing approval to Remicade in conjunction with methotrexate for inhibiting the progression of damage in patients with moderately to severely active rheumatoid arthritis who've had an inadequate response to methotrexate. The FDA approved Remicade for treatment of signs and symptoms of rheumatoid arthritis in patients who've had inadequate response to methotrexate in October 1999, and an FDA advisory panel unanimously recommended the drug's approval in the expanded indication in July. (See BioWorld Today, July 13, 2000.)
Cerus Corp., of Concord, Calif., and Baxter Healthcare Corp., of Deerfield, Ill., submitted a CE Mark application for European marketing approval for the Intercept Platelet System for pathogen inactivation in platelets intended for transfusion. If approved, the system will be the only of its kind in Europe.
Immusol Inc., of San Diego, said it discovered a potential target gene for breast and ovarian cancer, ID4. The gene, the company said, many be key in breast and ovarian cancers through preventing production of a beneficial anticancer protein, BRCA1. The discovery is detailed in the Jan. 2, 2001, issue of The Proceedings of the National Academy of Sciences.
IDEC Pharmaceuticals Corp., of San Diego, said the FDA accepted its biologics application license for Zevalin for filing. Zevalin is the company's radioimmunotherapy for treatment of low-grade, follicular, CD20-positive transformed, relapsed or refractory, B-cell non-Hodgkin's lymphoma (NHL) and Rituximab-refractory follicular NHL. The FDA also approved the company's request for priority review, and the company said the FDA should complete its review within six months. Idec filed the BLA in November. (See BioWorld Today, Nov. 2, 2000.)
MorphoSys AG, of Martinsried, Germany, and Biogen Inc., of Cambridge, Mass., entered a collaboration to apply MorphoSys' Human Combinatorial Antibody Library (HuCAL) antibody-generation technology for expressed sequence tags to efforts to validate drug targets in Biogen's genomics programs. Biogen gets an option to develop selected antibodies identified through the collaboration, and will pay MorphoSys research costs associated with the collaboration and an undisclosed up-front technology access fee in addition to milestone and royalty payments contingent upon antibody-based therapeutic development. Further financial details were undisclosed.
National Institutes of Health researchers said macrophages, specialized immune system cells, contain and continue to produce large amounts of an HIV-like virus in monkeys after the virus depletes CD4+ T cells. The research suggesting macrophages are a reservoir of virus in HIV infection offers researchers clues as to why the virus bounces back after antiretroviral therapy ends. Examination of lymph nodes and spleens of Macaques infected with SHIV, an exaggerated model of HIV infection in humans, showed that 95 percent of virus-producing cells were macrophages after the virus had depleted the monkeys' CD4+ T cells.
Oxford Biomedica plc, of Oxford, UK, said the Medicines Control Agency, the UK's National Health Service regulatory division, approved the company's request to begin a Phase I/II trial of TroVax, its cancer vaccine, in colorectal cancer. TroVax will be the second gene-based anticancer therapeutic to enter the clinic. The company also appointed nonexecutive director Peter Johnson nonexecutive chairman.
Oxxon Pharmaccines Ltd., of Oxford, UK, closed a #4.7 million (US$7.15 million) private funding round. Investors included existing shareholders MVM's UK Medical ventures Fund No. 1 and Neomed Innovations, in addition to new investors. The funding is earmarked for clinical program development and for development of the company's in-house research capabilities.
The University of Pittsburgh received a five-year, $14.3 million grant from the National Heart, Lung and Blood Institute (NHLBI) to establish the Cardiovascular Gene Therapy Center to focus on research into the treatment of cardiovascular disease using gene therapy. The grant also designates the University's Human Gene Therapy Applications Laboratory as the only national facility for the production of vectors for use in all future NHLBI-funded gene therapy clinical studies.
Transkaryotic Therapeutics Inc., of Cambridge, Mass., submitted an investigational new drug application to the FDA to begin a Phase I/II trial of the company's Niche Protein product, iduronate-2-sulfatase, an enzyme replacement therapy for treatment of Hunter's syndrome. The dose-ranging, randomized trial is designed to assess the therapy's safety, pharmacokinetics and clinical activity in 12 patients.
United Therapeutics Corp., of Silver Spring, Md., said it formed a company with the inventor of a form of gene therapy for pulmonary hypertension, Duncan Stewart. The company, Endogen, will be majority owned by UT, and minority owned by Stewart's technology development company and Dacha Capital, a Montreal-based investment firm. Endogen will receive exclusive license to the invention in addition to Canadian marketing rights to Unipeg, UT's second-generation prostacyclin analogue.
Zymark Corp., of Hopkinton, Mass., and Bayer Corp.'s Diagnostics Business Group, of Tarrytown, N.Y., entered a collaborative effort providing an automated platform for cell-based compound screening. The assay solutions package will run Bayer's QuantiGene assays on Zymark's Staccato Workstation, and includes Bayer's QuantiGene HV kit and ProbeDesigner Software. Financial details were undisclosed.