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Isotechnika (Edmonton, Canada) has received permission from the US Food and Drug Administration for the long-term use of ISA247 for the prevention of rejection in patients currently participating in its Phase IIb kidney transplant (PROMISE) trial.
The company has also received a “no objection” letter from Health Canada for the long-term use of ISA247 in the trial. After completion of the 12-month trial, patients choosing to remain on ISA247 therapy will continue to have safety and efficacy parameters monitored. The objective is to gather long term safety and efficacy data in newly transplanted patients.
The trial, managed by Clinical Trial and Consulting Services (Cincinnati, Ohio), involves 334 patients at 42 centres in North America, including 38 in the US and four in Canada. The primary endpoint is non-inferiority in biopsy-proven acute rejection episodes in patients receiving ISA247 for six months compared with the control (tacrolimus - the leading North American transplant drug in this class). The overall goal is to find the most appropriate dose that will result in efficacy (lack of acute rejection) with minimal side-effects that are typically seen with other calcineurin inhibitors.
ISA247 has successfully completed a Phase III Canadian trial for the treatment of moderate to severe psoriasis, and is currently being investigated in a Phase III European/Canadian psoriasis trial. Submitted by www.jobs4dd.com.
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