Pharmacology
Health Canada Issues No Objection Letter to Begin Phase IIb Kidney Transplant Trial for ISA247
By Isotechnika Inc.
May 2, 2005, 10:11

Isotechnika Inc. announced today that the Company received a No Objection Letter from Health Canada for the commencement of a Phase IIb kidney transplant trial for its lead immunosuppressive drug, ISA247.

This randomized, open-label trial will include approximately 332 de novo (newly transplanted) kidney patients. 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 have received the No Objection Letter for this trial in de novo transplant patients as this will facilitate the continuation of our advanced clinical program in transplantation. Based on our previously successful Phase IIa kidney transplant trial in stable patients where we met our efficacy and safety endpoints, we believe that this Phase IIb trial should also be successful," stated Dr. Randall Yatscoff, Isotechnika's
President & COO. "The company will commence clinical trial site selection in the near future with patient recruitment to begin by the end of the year."

All rights reserved by www.rxpgnews.com