Isotechnika Announces Interim Three Month Data From Phase 2b Kidney Transplant Trial
Edmonton, Alberta (ots/PRNewswire)
Isotechnika Inc. today announced 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 mg/kg twice daily) resulting in 11% incidence of acute rejection; 25 patients treated with the mid dose (0.6 mg/kg twice daily) resulting in 8% incidence of acute rejection; and 29 patients treated with the high dose (0.8 mg/kg twice daily) resulting in 3% incidence of acute rejection, as compared to 34 patients treated with tacrolimus, resulting in 9% 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% rate of acute rejection in the ISA247 groups compared to a 9% 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 ongoing 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 post-transplant, 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 to 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 continues to support that all three ISA247 doses are efficacious with very good kidney function in each dose group," stated Dr. Randall Yatscoff, President & CEO 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% 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 9:00 a.m. ET/7:00 a.m. MT. All interested parties will be able to access the live event (audio only) through the Company's corporate web site at www.isotechnika.com.
North American Phase 2b Kidney Transplant Trial 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. 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 mg/kg, 0.6 mg/kg, and 0.8 mg/kg twice daily compared with the fourth group, a tacrolimus (0.05 mg/kg twice daily) control arm. 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 will receive oral treatment of 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 safer than currently available treatments. Isotechnika looks to become the leader in development of immunosuppressant therapies. 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 combined Phase 3 European/Canadian psoriasis trial and a Phase 2b North American trial for the prevention of kidney graft rejection. One of our partners, Lux Biosciences, has received permission from the Food and Drug Administration to investigate ISA247 in three separate pivotal Phase 2/Phase 3 trials for the treatment of non-infectious uveitis and as a maintenance therapy in uveitis.
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.
Partnerships
Isotechnika Inc. 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 September 30, 2005, Isotechnika Inc. entered into an exclusive worldwide licensing agreement with Atrium Medical Corporation 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 Inc. and Cellgate Inc. signed an option agreement on April 25, 2006, granting Isotechnika the option to obtain an exclusive license 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 Inc. signed an agreement with Lux Biosciences, Inc. of Jersey City, New Jersey granting Lux Biosciences worldwide rights to develop and commercialize Isotechnika's lead drug, ISA247 for the treatment and prophylaxis of all ophthalmic diseases.
Forward-Looking Statements
This press release may contain forward-looking statements. Forward looking statements, including the Company's belief as to the potential of its products, the Company's expectations regarding the issuance of additional patents and the Company's ability to protect its intellectual property, involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the ability to economically manufacture its products, the potential of its products, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize its products, the ability of the Company to defend its patents from infringement by third parties, and the risk that the Company's patents may be subsequently shown to be invalid or infringe the patents of others. Investors should consult the Company's quarterly and annual filings with the Canadian commissions for additional information on risks and uncertainties relating to the forward- looking statements. Investors are cautioned against placing undue reliance on forward-looking statements.
Contact:
For further information: Dr. Randall Yatscoff, President & CEO,
Isotechnika Inc., Phone:+1-780-487-1600 Ext. 246,
Fax:+1-780-484-4105, Email: ryatscoff@isotechnika.com; Stephanie
Gillis-Paulgaard, Director, Corporate Communications, Isotechnika
Inc., Phone:+1-780-909-4661, Fax:+1-780-484-4105,
E-mail:sgillis-paulgaard@isotechnika.com