Isotechnika enrolls first patients in trial of immunosuppressive drug ISA247 for kidney transplant patients

By E. Janene Geiss

Philadelphia, Jan. 5 - Isotechnika Inc. said Thursday that it enrolled its first patient in a North American phase 2b kidney transplant trial for its lead immunosuppressive drug, ISA247, on Wednesday.

The trial will be performed at 34 centers across North America, including 29 in the United States and centers in Canada, according to a company news release.

A total of 332 newly transplanted kidney transplant patients will be enrolled in the trial.

Patients will be placed into one of four separate treatment groups; three different dose groups of ISA247 (0.4 mg, 0.6 mg and 0.8 mg twice daily) compared with the fourth group, a tacrolimus (0.05 mg twice daily) control arm, officials said.

Patients in all four treatment groups will have their doses adjusted in order to achieve predefined blood levels of either ISA247 or tacrolimus.

All patients will receive oral treatment of drug (ISA247 or tacrolimus) over a six-month period along with other standard immunosuppressive therapies used following transplantation, officials said.

The primary endpoint of the trial is defined as non-inferiority in biopsy-proven acute rejection episodes in patients receiving ISA247 for six months as compared to the tacrolimus control.

Kidney function and other laboratory parameters such as hypertension, hyperlipidemia and new onset diabetes mellitus will be monitored for the duration of the trial, officials said.

The overall goal of the trial is to find the most appropriate dose that will result in efficacy and lack of rejection, with minimal side effects that are typically seen with other calcineurin inhibitors such as cyclosporine and tacrolimus, officials said.

"We are excited to move ISA247 forward in the area of transplantation as well as for the treatment of psoriasis. We look forward to providing future progress reports to the investment and scientific communities in both of these areas," Randall Yatscoff, Isotechnika's president and chief executive officer, said in the release.

Isotechnika is Edmonton, Alta., biopharmaceutical company focused on the discovery and development of novel immunosuppressive therapeutics that are safer than currently available treatments.

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