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news.Isotechnika has received permission from the FDA for the long term use of its experimental compound in patients currently participating in the company's Phase IIb kidney transplant trial.
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The Canadian biopharmaceutical company previously announced in June that it had also received clearance from Health Canada for the long term use of the anti-rejection drug, ISA247, in this trial.
Patients involved in the trial are allowed to remain on ISA247 through to 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.
Dr Randall Yatscoff, Isotechnika’s president and CEO, said: “It is our belief that by having patients continue to receive ISA247 therapy we are contributing to an improved quality of life subsequent to transplantation. The long term data received from these patients will facilitate ISA247 achieving its commercial potential.”