NEW YORK (AP) — The first human clinical trials of a stem cell drug candidate are being planned after Geron Corp. said the FDA has cleared its application for a product intended to treat severe spinal cord injuries. Geron, based in Menlo Park, Calif., said Friday the FDA approved its investigational new drug application for GRNOPC1. The company is planning an early stage clinical trial, which is primarily intended to test the safety of a proposed drug, although effectiveness is also measured. In a statement, the head of the Christopher and Dana Reeve Foundation said the news is “an exciting first step” in helping patients with spinal cord injuries. The foundation gives research grants and organizes testing of therapies to treat spinal cord injuries. “There has been so much speculative and unsubstantiated information about the use of stem cells in spinal cord injury; it is important to study these cells in a rigorously designed clinical trial that is monitored by the FDA,” said Peter Wilderotter, the president and chief executive of the Reeve Foundation. Actor Christopher Reeve, who died in 2004, was paralyzed from the neck down in 1995 after a horseback riding accident. Lazard Capital Markets analyst Joel Sendek said that in addition to boosting Geron, the FDA approval “prove to be a major catalyst to stem cell research.” Sendek predicted the company will start trials by the middle of 2009 and report results by mid 2010. He said Geron could begin a mid-stage study, usually done to determine the most effective dose of a drug, in early 2011. GRNOPC1 will be tested at seven sites in the U.S., on patients who have suffered a grade A injury — the most severe type — to the thoracic spinal cord. Injuries to that part of the spinal cord cause paralysis of the abdominal muscles or chest muscles, and the lower extremities. The American Spinal Injury Association grades spinal health on a scale ranging from E, which indicates normal function, to A, in which patients who no motor or sensory function in the affected areas. Patients will be injected with the stem cells one to two weeks after their injuries. Geron has conducted 24 preclinical trials on animals, the company said. The GRNOPC1 cells were created from a line of human embryonic stem cells, which were created before a ban was instituted on federal funding for new lines of stem cell research. Geron said it has not received any federal funding in research on GRNOPC1.
