Isotechnika to continue phase II kidney transplant trial

The planned randomized, open-label trial will include approximately 332 newly transplanted kidney patients from clinical trial sites across North America. Isotechnika had previously received a letter from Health Canada on April 28, 2005 which had no objections to the 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.

Dr Randall Yatscoff, Isotechnika’s president & COO described the trial as important in consolidating and validating data from previous trials. “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 II trial,” stated Dr Randall. “Our goal, subject to available financial resources, is to commence North American site selection and patient recruitment by the end of the current year.”