FDA OK's Long Term Use of Kidney Rejection Preventative
CTI Announces the FDA allows long term use of ISA247 in Isotechnika Phase 2b clinical program for the prevention of rejection following kidney transplantation
CINCINNATI, OH, October 22, 2007-CTI Clinical Trial and Consulting Services (CTI) announced that Isotechnika has received permission from the U.S. Food and Drug Administration (FDA) for the long term use of ISA247 in patients currently participating in Isotechnika’s Phase 2b kidney transplant (PROMISE) trial. Isotechnika previously announced that they had also received a “No Objection” Letter from Health Canada for the long term use of ISA247 in this trial.
With these announcements, patients involved in the PROMISE trial are allowed to remain on ISA247 through commercialization of the drug and beyond after completion of the 12 month trial. Patients choosing to remain on ISA247 therapy will continue to have safety and efficacy parameters monitored on an ongoing basis. Isotechnika believes that having patients continue to receive ISA247 therapy may contribute to an improved quality of life subsequent to transplantation.
The long-term data received from these patients will facilitate ISA247 achieving its commercial potential. CTI is managing the multicenter North American trial on behalf of Isotechnika.
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