• AnorMED (Vancouver, British Columbia) reported filing for approval an investigational new drug application with the FDA to begin its clinical program for AMD3100 in cardiac patients. The filing is the first step in evaluating the potential of AMD3100, a stem cell mobilizer, to help repair damaged heart tissue in patients who have suffered heart attacks. "We are excited about the possibility that our lead drug candidate, AMD3100, may have additional therapeutic applications beyond the ongoing Phase III study for stem cell transplant in cancer patients," said Dr. Michael Abrams, CEO and president.
• Arrow International (Reading, Pennsylvania), a provider of central venous catheter products, introduced the Arrow Simplicity Micro-Puncture Introducer Set, a dialysis access product to be used in combination with Arrow's chronic hemodialysis catheters. The Arrow Simplicity uses a color-coded guidewire that facilitates catheter tip and exit site position, and defines necessary catheter length prior to catheter insertion. The company said the tip-first, retrograde-tunneled design of the Cannon provides fast, exact tip placement with superior flow, clearances and patency that lead to superior dialysis outcomes.
• Cardinal Health (Dublin, Ohio) said it has been granted its first patent for a technology that will help in the mass production of biopharmaceuticals. The company received U.S. patent No. 6,852,510, titled "Host cells containing multiple integrating vectors," for its gene product expression technology platform. Cardinal Health's GPEx technology enables rapid genetic engineering of stable mammalian cell lines.
• Corgentech (South San Francisco, California) and Bristol-Myers Squibb (Princeton, New Jersey) reported top-line results from PREVENT IV, a Phase III clinical trial evaluating the use of edifoligide (E2F Decoy) to prevent vein graft failure following coronary artery bypass graft surgery. The companies said treatment with Corgentech's E2F Decoy failed to meet the trial's primary and secondary endpoints. E2F Decoy was generally well tolerated in the 3,014-patient trial. The complete data from the PREVENT IV trial will be presented in future publications and presentations by the study's clinical investigators. Bristol-Myers Squibb said it has advised Corgentech that it will be terminating the collaboration on the E2F Decoy, consistent with the terms of their agreement.
• IsoTis OrthoBiologics (Lausanne, Switzerland/Irvine, California) said it has received FDA 510(k) clearance for its DynaGraft II product family for orthopedic applications. DynaGraft II, part of IsoTis' portfolio of bone graft substitutes, is derived from demineralized bone matrix and delivered in a reverse phase medium for optimal graft containment.
• RITA Medical Systems (Mountain View, California) said that an article published in the March 1, 2005, issue of the Journal of Clinical Oncology reported long-term survival rates for 135 patients treated with radio frequency ablation (RFA) for hepatic colorectal metastases at the Cleveland Clinic (Cleveland). The study enrolled people with metastatic colorectal cancer who had progressed despite prior chemotherapy treatment. The authors concluded that the results of the study suggest the addition of RFA to modern chemotherapy provides "a survival advantage when compared to chemotherapy alone." The authors noted that while surgical resection is still the gold standard for treatment, "only 10% to 20% of [colorectal liver metastases] patients are candidates for resection because of extensive disease or medical co-morbidities." The company said that the results of the study may have the effect of expanding the population of patients with colorectal liver metastases considered candidates for the procedure because extra-hepatic disease was shown to not negatively impact survival.