Last patient in Isotechnika's phase 2b kidney transplant trial completes six month treatment
EDMONTON, Jan. 3, 2008 (Canada NewsWire via COMTEX News Network) --
Isotechnika Inc. (TSX:ISA) announced today that the last patient enrolled in the Company's Phase 2b kidney transplant trial has completed the six month trial.
"The six month data is expected to be available in the second quarter of this year," stated Dr. Robert Foster, Isotechnika's Chairman & CEO. "We believe that the final data will confirm ISA247 as an efficacious treatment for kidney transplant patients with an enhanced safety profile over current calcineurin inhibition therapies. Efficacy and enhanced safety profile will be key characteristics of the next generation of calcineurin inhibitors and ensure that calcineurin inhibition remains the foundation of evidence based medicine."
Patients who have completed the six months trial were provided the opportunity to continue treatment with ISA247 as part of an extension to the initial trial. This six month extension period will provide longer term safety and efficacy data for the drug in de novo kidney transplant patients.
On June 7, 2007 and August 2, 2007, Isotechnika received permission from Health Canada and from the Food and Drug Administration, respectively, to allow patients to remain on ISA247 until the drug is commercially available.
North American Phase 2b Kidney Transplant Trial Design
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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 leading North American transplant drug in this class. Additionally, kidney function and other laboratory parameters 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 acute rejection) with minimal side effects. The use of the other two calcineurin inhibitors, cyclosporin and tacrolimus, are often associated with significant safety concerns.
A total of 334 de novo (newly transplanted) kidney transplant patients have been enrolled in this trial. Patients were 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 control arm (0.05 mg/kg twice daily). 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 received oral dosing with the drug (ISA247 or tacrolimus) over a six month period along with other standard immunosuppressive therapies used following transplantation.
About Isotechnika
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. 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.
ISA247 is currently being investigated in a Phase 2b North American trial for the prevention of kidney graft rejection subsequent to transplantation and a Phase 3 European/Canadian psoriasis trial.
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.
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Partnerships with Isotechnika Inc.
- Roche retains an option to continue development of the transplant
indications based on the successful completion of the ongoing Phase
2b kidney transplant trial.
- Atrium Medical Corporation has exclusive worldwide licensing
agreement for use of ISA247 and TAFA93 with drug eluting devices for
non-systemic treatment of vascular, cardiovascular, target vessel and
tissue disorders.
- Lux Biosciences Inc. was granted worldwide rights to develop and
commercialize ISA247 for the treatment and prophylaxis of all
ophthalmic diseases.
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