July 5, 2007
CTI Clinical Trial and Consulting Services (CTI) announced the completion of patient enrolment in the Isotechnika Phase 2b trial assessing ISA247 for the prevention of kidney graft rejection following transplantation. Of the 332 patients enrolled, 148 patients have already completed the required six months of treatment. Isotechnika expects to have the last patient complete the six months of active treatment before the end of the year. Upon receipt of final results, Isotechnika expects to submit applications to conduct the pivotal Phase 3 trials that are required for market approval. CTI is managing this multicenter North American trial on behalf of Isotechnika.
“We would like to thank the investigators and clinical sites for their efforts in recruiting and enrolling patients into this valuable clinical trial,” said Timothy J. Schroeder, President and CEO of CTI Clinical Trial and Consulting Services. “We would also like to thank Isotechnika for entrusting the management of this important trial to us.”
North American Phase 2b Kidney Transplant Study Design
Forty-two centers across North America have been contracted to perform the trial, including thirty-eight centers in the United States and four centers in Canada. 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 which is currently the North American leading transplant drug in this class. The overall goal of the trial is to find the most appropriate dose that will result in efficacy (lack of acute rejection) with minimal side effects that are typically seen with other calcineurin inhibitors.
A total of 332 de novo (newly transplanted) kidney transplant patients are enrolled in this trial. Patients have been 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 (0.005 mg/kg twice daily) control arm. Patients in all four treatment groups have their doses adjusted in order to achieve pre-defined blood levels of either ISA247 or tacrolimus. All patients receive treatment over a six month period along with other standard immunosuppressive therapies used following transplantation. Patients completing the six month trial are given the option to continue therapy for one year. The objective is to gather long term safety and efficacy data in de novo transplant patients.
Edmonton-based Isotechnika Inc. is an international biopharmaceutical company focused on the discovery and development of novel immunosuppressive therapeutics that are designed to offer advantages over other currently available treatments while offering therapeutic choices to clinicians. Isotechnika looks to become the market leader of drug therapies for indications such as transplantation of solid organs (with Hoffman La Roche) and treatment of autoimmune disorders such as uveitis (with Lux Biosciences) and psoriasis.
There is a significant unmet medical need in the treatment of both solid organ transplantation and autoimmune disease. It is estimated that the market potential exceeds $2 billion annually in sales for calcineurin inhibitors such as ISA247.
Isotechnika’s lead drug, ISA247, has successfully completed a Phase 3 Canadian trial for the treatment of moderate to severe psoriasis. ISA247 is currently being investigated in a Phase 3 European/Canadian psoriasis trial and a Phase 2b North American trial for the prevention of kidney graft rejection subsequent to transplantation.
Isotechnika Inc. is a publicly traded company on the Toronto Stock Exchange under the symbol “ISA”. More information on Isotechnika can be found at www.isotechnika.com