In Brief: Nexell Therapeutics
This article was originally published in The Gray Sheet
Executive Summary
Nexell Therapeutics: Baxter/VimRx cell therapy joint venture submits a premarket approval application supplement to a pending PMA for the Isolex 300 semi-automated stem cell selection system. The supplement requests FDA review of the firm's Isolex 300i fully automated system, which, like the Isolex 300, is intended for enrichment of CD34+ cells and the reduction of non-target (non CD34+) cells in cryopreserved autologous peripheral blood stem cell products that are reinfused into patients undergoing autologous peripheral blood transplantation. The transplantation procedure is used to restore a patient's blood and immune system following high-dose chemotherapy. Data in support of the PMA supplement was submitted to FDA from three separate trials, one of which involved 114 patients (92 randomized) with high risk or advanced breast cancer. During a review of the original Isolex submission in July, FDA's Biological Response Modifiers Advisory Committee did not take a formal vote on the PMA, but did agree that study data demonstrated efficacy ("The Gray Sheet" July 28, 1997, p. 8)...