Isotechnika releases phase 2b kidney trial results
2007-05-07 06:19 ET - News Release
Dr. Randall Yatscoff reports
ISOTECHNIKA ANNOUNCES INTERIM THREE MONTH DATA FROM PHASE 2B KIDNEY TRANSPLANT TRIAL
Isotechnika Inc. today released the audited three month results, reviewed by the data monitoring committee, of the first third of the patients treated in its phase 2b de novo kidney transplant trial for the company's lead immunosuppressive drug, ISA247.
This interim analysis is based upon the assessment of the first 116 patients enrolled. There have been 28 patients treated with the low dose (0.4 milligram per kilogram twice daily) resulting in 11-per-cent incidence of acute rejection; 25 patients treated with the mid-dose (0.6 milligram per kilogram twice daily) resulting in 8-per-cent incidence of acute rejection; and 29 patients treated with the high dose (0.8 milligram per kilogram twice daily) resulting in 3-per-cent incidence of acute rejection, as compared with 34 patients treated with tacrolimus, resulting in 9-per-cent incidence of acute rejection. All rejection episodes were appropriately treated. No transplanted kidneys have been lost. When all three of the ISA247 dosing groups are combined, there is a 7-per-cent rate of acute rejection in the ISA247 groups, compared with a 9-per-cent rate of acute rejection in the tacrolimus group, which is being dosed optimally.
As part of the trial, kidney function is being measured on an continuing basis by Glomerular filtration rate (GFR). Based on the data generated to date, very good kidney function has been observed in all of the ISA247 dosing groups. Within the first month of posttransplant, kidney function showed improvement across all ISA247 dosing groups similar to that observed in the tacrolimus group. Fewer incidences of hypomagnesemia, neurological side effects and new onset diabetes mellitus have been observed with all ISA247 dosing groups as compared with tacrolimus. There have been no clinically significant differences noted in blood pressure, lipids (cholesterol and triglycerides) or other laboratory parameters examined to date. Additionally, the strong pharmacokinetic/pharmacodynamic correlation seen with ISA247 remains consistent with previous data reported which should facilitate ease of dosing to target concentrations and effect.
"The interim three-month data continue to support that all three ISA247 doses are efficacious with very good kidney function in each dose group," stated Dr. Randall Yatscoff, president and chief executive officer of Isotechnika. "Most encouraging is the low rate of acute rejection coupled with an improved safety profile. To date, the company has enrolled 277 patients of the 332 patients required for this trial. We are also encouraged that 100 per cent of the patients have opted to continue receiving therapy for an additional six months after completing the first six months of the trial."
The management team will provide a review of the phase 2b kidney transplant trial via a live conference call this morning at 9 a.m. ET/7 a.m. MT. All interested parties will be able to access the live event (audio only) through the company's corporate web site.
North American phase 2b kidney transplant trial design
Forty-two centres across North America have been contracted to perform the trial, including 38 centres in the United States and four centres in Canada. The primary end point of the trial is defined as non-inferiority in biopsy proven acute rejection (BPAR) episodes in patients receiving ISA247 for six months as compared with the tacrolimus control which is currently the North American leading 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 that are typically seen with other calcineurin inhibitors such as cyclosporine and tacrolimus.
A total of 332 de novo (newly transplanted) kidney transplant patients 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 milligram per kilogram, 0.6 milligram per kilogram and 0.8 milligram per kilogram twice daily, compared with the fourth group, a tacrolimus (0.05-milligram-per-kilogram-twice-daily) control arm. Patients in all four treatment groups will have their doses adjusted in order to achieve predefined 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.
Partnerships
Isotechnika signed a collaboration agreement with Hoffman La Roche on April 9, 2002, which licensed the worldwide rights to develop and commercialize ISA247 for all transplant indications.
On Sept. 30, 2005, Isotechnika entered into an exclusive worldwide licensing agreement with Atrium Medical for the use of ISA247 and TAFA93 specifically with drug eluting devices for the non-systemic treatment of vascular, cardiovascular, target vessel and tissue disorders.
Isotechnika and Cellgate signed an option agreement on April 25, 2006, granting Isotechnika the option to obtain an exclusive licence to develop and commercialize conjugates consisting of Cellgate's patented transporter technology for the topical delivery of ISA247 in patients suffering from mild-to-moderate psoriasis.
On May 25, 2006, Isotechnika signed an agreement with Lux Biosciences of Jersey City, N.J., granting Lux Biosciences worldwide rights to develop and commercialize Isotechnika's lead drug, ISA247 for the treatment and prophylaxis of all ophthalmic diseases.
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