February 6, 2006
CTI Clinical Trial and Consulting Services (CTI) announced the beginning of patient enrollment in a Phase IIB clinical program of ISA247 for the prevention of organ graft rejection in patients undergoing kidney transplantation. CTI is managing the clinical trial program on behalf of Isotechnika Inc.
Over the past twenty-five years, the introduction of new immunosuppressive agents and improved transplant patient management techniques have led to a lower incidence of acute rejection episodes and improved long-term outcomes. Preserving renal function post-transplant continues to be an important concern for physicians managing solid organ transplant recipients, as renal function has been found to be one of the key predictors of long-term graft survival. “While calcineurin inhibitors have been the cornerstone of immunosuppression for more than two decades, there are toxicities associated with their use. Clinicians continue to search for an immunosuppression regimen that results in excellent, long-term outcomes,” said Eliezer Katz, MD, CTI Medical Director and ISA247 Study Medical Monitor.
The ISA247 trial will be performed at thirty-four centers across North America, including twenty-nine centers in the United States and five centers in Canada. A total of 332 de novo (newly transplanted) kidney transplant recipients will be enrolled in this trial. Patients will be placed into one of four separate treatment groups; three different dose groups of ISA247 (0.4 mg/kg, 0.6 mg/kg, and 0.8 mg/kg twice daily) compared with the fourth group, a tacrolimus (0.05 mg/kg twice daily) control arm. Patients in all four treatment groups will have their doses adjusted in order to achieve pre-defined 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.
The primary endpoint of the trial is defined as non-inferiority in biopsy proven acute rejection (BPAR) episodes in patients receiving ISA247 for six months as compared to the tacrolimus control. Additionally, kidney function and other laboratory parameters such as hypertension, hyperlipidemia and new onset diabetes mellitus will be monitored for the duration of the trial. The overall goal of the trial is to find the most appropriate dose that will result in efficacy (lack of rejection) with minimal side effects that are typically seen with calcineurin inhibitors.
“Randall W. Yatscoff, PhD, Isotechnika President and CEO, is a long-time friend and colleague who has been in the field of transplant immunosuppression development for many years. CTI was founded on the premise of developing new treatment options for transplant recipients. As such, we are excited to be working with Isotechnika Inc. on this development program and are delighted to be assisting in adding ISA247 to the armamentarium of transplant clinicians.” said Timothy J Schroeder, President and CEO of CTI Clinical Trial and Consulting Services.
About Isotechnika Inc.
Isotechnika Inc. (http://www.isotechnika.com) is an international biopharmaceutical company headquartered in Edmonton, Alberta, Canada. Isotechnika Inc. is a publicly traded company on the Toronto Stock Exchange under the symbol ISA. Because of its expertise in medicinal chemistry and immunology, the Company is focused on the discovery and development of novel immunosuppressive therapeutics that are safer than the currently available treatments. The Isotechnika team consists of entrepreneurial management and a world-class team of scientists who are building a pipeline of immunosuppressive drug candidates for treatment of autoimmune diseases and for use in the prevention of organ rejection in transplantation. Isotechnika looks to become the leader in the development of immunosuppressant therapies. Isotechnika's lead compound, ISA247 is an immunosuppressant currently in an extension protocol of a Canadian Phase III human clinical trial for treatment of moderate to severe psoriasis. In addition, ISA247 has successfully completed a Phase IIa trial for kidney transplantation.