CTI Announces the FDA Allows Long Term Use of ISA247 in Isotechnika Phase 2b Clinical Program for the Prevention of Rejection Following Kidney Transplantation
CINCINNATI, October 22, 2007- CTI Clinical Trial and Consulting Services (CTI) announced that Isotechnika has received permission from the U.S. Food and Drug Administration (FDA) for the long term use of ISA247 in patients currently participating in Isotechnika’s Phase 2b kidney transplant (PROMISE) trial. Isotechnika previously announced that they had also received a “No Objection” Letter from Health Canada for the long term use of ISA247 in this trial.
With these announcements, patients involved in the PROMISE trial are allowed to remain on ISA247 through commercialization of the drug and beyond after completion of the 12 month trial. Patients choosing to remain on ISA247 therapy will continue to have safety and efficacy parameters monitored on an ongoing basis. Isotechnika believes that having patients continue to receive ISA247 therapy may contribute to an improved quality of life subsequent to transplantation.
The long-term data received from these patients will facilitate
ISA247 achieving its commercial potential. CTI is managing
the multicenter North American trial on behalf of
“We are proud to be a part of such a valuable clinical trial that is producing such positive data,” said Timothy J. Schroeder, President and CEO of CTI Clinical Trial and Consulting Services. “We would like to thank the investigators and study coordinators for their great efforts to make this clinical trial a success and also to thank Isotechnika for allowing CTI to be a part of it.”
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 334 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.
About CTI Clinical Trial and Consulting Services
CTI Clinical Trial and Consulting Services (CTI) is a unique drug and market development company offering a full range of services which encompass the entire lifecycle of drug development. These services include regulatory pathway design, clinical trial management, data analysis, medical writing, CME and training program development, market analysis and development and other consulting services. CTI focuses on the specific disease areas of solid organ transplant, hepatitis, infectious disease, end-stage organ disease and hematology/bone marrow transplant. With its combined expertise of clinical knowledge and market experience, CTI is uniquely positioned to incorporate both clinical and market driven endpoints and interpretations to provide extraordinary results.
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 and treatment of autoimmune disorders such as uveitis 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
Posted: October 2007