Drug Company Halts Late-Stage Trial of Sickle-Cell Disease Drug, Citing Ineffectiveness in Pain Relief
Durham, N.C.-based drug manufacturer Icagen announced that it has ended its Phase III clinical trial of its sickle-cell treatment senicapoc, citing lack of effectiveness, the Raleigh News & Observer reports. Sickle-cell disease is a genetic blood disorder primarily affecting blacks, but can also be found Hispanics and people from the Middle East, Southeast Asia and the Mediterranean region. Final testing in the 160-participant senicapoc study began in February 2005, and concerns about the treatment's effectiveness arose in August 2006 after the study's data monitoring committee suggested that senicapoc likely would benefit only a small number of people. Icagen and Johnson & Johnson -- which paid $15 million to market and help develop the drug -- at that point decided to adjust the number of participants and treatment options being tested in the trial. Recently, the committee said preliminary trial data show that senicapoc does not prevent chronic pain, one of the disease's most prominent complications. However, the drug consistently has been able to reduce the number of deformed blood cells associated with the disease, the News & Observer reports. That effect "might make the drug suitable to reduce elevated blood pressure in the lungs of some sickle-cell patients and the stroke risk for pediatric sickle-cell patients," according to the News & Observer. Currently, there is only one other treatment available for the disease. Richard Katz, Icagen's senior vice president of finance and corporate development, said that despite the findings, "it would be premature to say senicapoc is dead." He said the drug's future should be clearer in a few months (Vollmer, Raleigh News & Observer, 4/5).This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.