Isotechnika Releases Final Results of Phase IIa Kidney Transplant Trial at American Transplant Congress
Wednesday June 4, 8:00 am ET
Trades on Toronto Stock Exchange - (TSX:ISA) www.isotechnika.com
EDMONTON, June 4 /CNW/ - Isotechnika Inc. announced today that the Company presented the final results of its Phase IIa kidney transplant study at the American Transplant Congress in Washington, D.C. Designed to evaluate ISA247, Isotechnika's lead immunosuppressive drug, in stable kidney transplant patients, the study showed positive results and demonstrated that ISA247 was well tolerated and efficacious. All of the primary and secondary endpoints of the study were achieved.
The primary endpoint of the trial was to demonstrate that stable kidney transplant patients on ISA247 experienced no change in kidney function when compared to patients in the cyclosporine (Neoral(R) formulation) arm of the study. One of the secondary endpoints of the study was to monitor safety parameters in kidney transplant patients receiving ISA247; one of which was to measure the incidence of graft rejection. The final secondary endpoint of the study was to measure the pharmacodynamics and pharmacokinetics of ISA247 in kidney transplant patients. The data showed that all of these endpoints were met.
"We are very pleased with the results of this study. The safety and increased potency of ISA247 demonstrated in previous clinical trials was confirmed again in this study with stable kidney transplant patients." stated Dr. Randall Yatscoff, President and COO. "This trial convincingly shows that kidney transplant patients can switch to ISA247 in a safe and effective manner. The data also demonstrated that ISA247 achieved a level of immunosuppression comparable to cyclosporine at one third the blood drug concentration clearly illustrating its increased potency. Patients in the ISA247 arm of the study showed no change in kidney function when compared to the cyclosporine group thereby providing further confirmation of drug safety. We are looking forward to a continuation of these promising results in future clinical trials."
The kidney transplant study was an open label, randomized, multi-center trial conducted at twenty centers in Canada and the United States. The study protocol was designed for stable kidney patients who were at least six months post-transplant. The study was randomized with one patient receiving a dose of ISA247 and one patient receiving a dose of cyclosporine. A total of 132 patients participated in the twelve week study with 67 patients in the cyclosporine group and 65 patients in the ISA247 arm. At the end of the study, the ISA247 patients were monitored for one week and then returned to their previous cyclosporine dosing regimen.
Investors and other interested parties are invited to view the Company's presentation at the American Transplant Congress on Isotechnika's website at www.isotechnika.com.
About ISA247
ISA247 is a novel calcineurin inhibitor in Phase II clinical development as immunosuppressive therapy in organ transplantation and in the treatment of autoimmune diseases. Early studies indicate that ISA247 is considerably more potent and less toxic compared to other immunosuppressants, such as cyclosporine A. This powerful combination of reduced toxicity and improved potency should provide a major therapeutic benefit over existing calcineurin based regimens. ISA247 is being developed under a global collaboration agreement with Roche.
[Nothing about the slight increase in adverse effects. They should have mentioned them, as the information is available in the abstract.
I was concerned about what they referred to as "nervous system disorders (14% and 8%)". But perhaps that increase can be put down to "of which headache was most common". I guess most people would accept some headache and perhaps an unruly stomach if it also means that the new kidneys would get a better chance of long-term survival]. |
