• Alliance Pharmaceutical Corp., of San Diego, has updated its clinical development plan for Oxygent (perfluorochemical [PFC] emulsion) to focus primarily on supporting the initial clinical development of Oxygent in China. That involves investigating Oxygent in maintaining hemodynamic stability during major surgery, potentially reducing or avoiding intraoperative transfusions of donor blood in major surgery. A Phase II trial in China will incorporate oxygenation endpoints of postoperative improvement of organ function, such as the gut, heart, brain and kidney. Also, Alliance will discontinue enrollment in a current French study and evaluate a new protocol to correspond to the China Phase II study. Alliance is transferring the manufacturing technology to enable Double-Crane to manufacture Oxygent in China, and then plans to submit an investigational new drug application to the FDA, which is anticipated to be completed in 2008. The company said it will seek additional funding to support this plan.
• Inviragen LLC, of Fort Collins, Colo., received a two-year, $600,000 Small Business Technology Transfer award from the National Institutes of Health. The funding will support Inviragen's collaboration with the University of Wisconsin to develop an avian influenza vaccine.
• Ipsen SA, of Paris, and Celera Group, of Alameda, Calif., formed a research collaboration to develop biomarker and pharmacogenomic tests for growth failure. Celera will receive an undisclosed payment for the initial phase of the collaboration, which will focus on discovering biomarkers that eventually would be used to develop companion diagnostics for Ipsen's short stature drugs.
• Kyto Biopharma Inc., of Toronto, said it conclusively isolated the protein and gene encoding the human vitamin B12 receptor - TCbIR for the cellular uptake of the transcobalamin-bound vitamin B12. TCbIR is overexpressed in cancer cells, and Kyto has initiated a program to develop targeted human monoclonal antibodies to that target to treat various forms of cancer. The company entered an agreement with third-party providers to manufacture murine antibodies for development of compounds targeting TCbIR.
• Labopharm Inc., of Laval, Quebec, said the FDA did not overturn its previous approvable decision for once-daily tramadol in response to the company's appeal. Labopharm plans to continue its appeal process, which it started after receiving a second approvable letter in May for its once-daily formulation of the pain drug tramadol. Shares of Labopharm (NASDAQ:DDSS) fell 20 cents, or 17.2 percent, to close at 96 cents on Wednesday. (See BioWorld Today, June 4, 2007.)
• Spectrum Pharmaceuticals Inc., of Irvine, Calif., said the FDA delayed the action date on the new drug application for ISO-Vorin (levofolinic acid, or LFA) in the treatment of osteogenic sarcoma by 60 days. An approval decision is now expected March 7, 2008. LFA is the pure active isomer of calcium leucovorin and is marketed outside the U.S. for cancer.
• St. Jude Children's Research Hospital said its investigators have discovered a new signaling molecule that prevents immune responses from damaging the body. The team discovered that regulatory T cells release a protein complex composed of two proteins called Ebi3 and Il12a, which act like a brake on the activity of the aggressive immune cells called effector T lymphocytes. St. Jude said the discovery is important because the manipulation of regulatory T cells is a key goal of immunotherapy. A report on the discovery appears in the Nov. 22, 2007, issue of Nature.