Isotechnika's independent data monitoring committee conducts review of phase 2b kidney transplant trial
EDMONTON, March 27 /CNW/ - Isotechnika Inc. announced today that an independent data monitoring committee (DMC) has met and reviewed the interim data from the Phase 2b kidney transplant (PROMISE) trial. The review included 3 month data from approximately 1/3 of the anticipated 332 patients to be enrolled. The DMC has recommended that the trial continue according to the original study design. There were no concerns in this review with regards to the safety or efficacy of ISA247 in this patient population.
"The DMC was formed as a special safeguard to ensure the best interests of the patients participating in this trial," commented Dr. Yatscoff, Isotechnika's President & CEO. "Their independent review of the three month data is consistent with our internal analysis which suggests that ISA247 is safe and efficacious in this patient population."
Following the independent review by the DMC, Isotechnika is set to host an evening symposium at the American Transplant Congress this May. Further details regarding the symposium will be forthcoming.
North American Phase 2b Kidney Transplant Study Design
Forty-one centers across North America have been contracted to perform the trial, including thirty-seven 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 -----------------
Isotechnika Inc. is an international biopharmaceutical company headquartered in Edmonton, Alberta, Canada. Drawing upon its expertise in medicinal chemistry and immunology, the Company is focused on the discovery and development of novel immunosuppressive therapeutics that are safer than currently available treatments. Its entrepreneurial management and world-class team of scientists are building a pipeline of immunosuppressive drug candidates for treatment of autoimmune diseases and for use in the prevention of organ rejection in transplantation. Isotechnika looks to become the leader in development of immunosuppressant therapies. Isotechnika's lead compound, 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. Our partner, Lux Biosciences has received permission from the Food and Drug Administration to investigate ISA247 in three separate pivotal Phase2/Phase 3 trials for the treatment of non-infectious uveitis and as a maintenance therapy in uveitis. The Company also successfully completed Phase 1 clinical trials of an additional immunosuppressive compound in its drug pipeline, TAFA93. 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 with Isotechnika Inc. ----------------------------------
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. %SEDAR: 00010508E
/For further information: Dr. Randall Yatscoff, President & COO, Isotechnika Inc., Phone: (780) 487-1600 Ext. 246, Fax: (780) 484-4105, Email: firstname.lastname@example.org; Stephanie Gillis-Paulgaard, Director, Corporate Communications, Isotechnika Inc., Phone: (780) 487-1600 Ext. 243, Fax: (780) 484-4105, E-mail:email@example.com/
Posted: March 2007