From rxpgnews.com
FDA Permits Phase IIb Kidney Transplant Trial
By Isotechnika Inc.
May 13, 2005 - 5:45:00 PM
Isotechnika Inc. announced today that the Company has received permission from the Food and Drug Administration of the United States to proceed with a Phase IIb kidney transplant trial for its lead immunosuppressive drug, ISA247.
The planned randomized, open-label trial will include approximately 332 de novo (newly transplanted) kidney patients from clinical trial sites across North America. The Company previously received a No Objection Letter from Health Canada on April 28, 2005 to begin the Phase IIb kidney transplant trial.
Patients will be placed into one of four separate dosing groups. The four dosing groups will be comprised of three different targeted blood concentrations of ISA247 compared with the fourth group, a tacrolimus control arm. All patients will receive twice daily oral treatment of drug over a 24-week period. Treatment will commence at the time of transplant surgery.
The primary endpoint of the trial is defined as non-inferiority in biopsy proven acute rejection (BPAR) episodes with patients receiving ISA247 for six months as compared to tacrolimus. Additionally, patient's kidney function and other laboratory parameters such as hypertension, hyperlipidemia and new onset diabetes mellitus will be monitored for the duration of the trial.
"We are extremely pleased to receive permission from the FDA to conduct this Phase IIb trial as it validates the bridging studies performed by the Company last year. As a result of changing the manufacturing to the trans-ISA247, it was necessary to complete a number of bridging studies prior to filing for regulatory approval to commence the Phase IIb trial," stated Dr. Randall Yatscoff, Isotechnika's President & COO. "Our goal, subject to available financial resources, is to commence North American site selection and patient recruitment by the end of the current year."
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