Health Canada Issues No Objection Letter to Begin Phase IIb Kidney Transplant Trial for ISA247
May 2, 2005 - 10:11:00 AM
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"We are extremely pleased to have received the No Objection Letter for this trial in de novo transplant patients as this will facilitate the continuation of our advanced clinical program in transplantation. Based on our previously successful Phase IIa kidney transplant trial in stable patients where we met our efficacy and safety endpoints, we believe that this Phase IIb trial should also be successful."
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By Isotechnika Inc.,
[RxPG] Isotechnika Inc. announced today that the Company received a No Objection Letter from Health Canada for the commencement of a Phase IIb kidney transplant trial for its lead immunosuppressive drug, ISA247.
This randomized, open-label trial will include approximately 332 de novo (newly transplanted) kidney patients. Patients will be placed into one of four separate dosing groups. The four dosing groups will be comprised of three different targeted blood concentrations of ISA247 compared with the fourth group, a tacrolimus control arm. All patients will receive twice daily oral treatment of drug over a 24 week period. Treatment will commence at the time of transplant surgery.
The primary endpoint of the trial is defined as non-inferiority in biopsy proven acute rejection (BPAR) episodes with patients receiving ISA247 for six months as compared to tacrolimus. Additionally, patient's kidney function and other laboratory parameters such as hypertension, hyperlipidemia and new onset diabetes mellitus will be monitored for the duration of the trial.
"We are extremely pleased to have received the No Objection Letter for this trial in de novo transplant patients as this will facilitate the continuation of our advanced clinical program in transplantation. Based on our previously successful Phase IIa kidney transplant trial in stable patients where we met our efficacy and safety endpoints, we believe that this Phase IIb trial should also be successful," stated Dr. Randall Yatscoff, Isotechnika's
President & COO. "The company will commence clinical trial site selection in the near future with patient recruitment to begin by the end of the year."
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Additional information about the news article
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About Isotechnika Inc.
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 is an immunosuppressant currently in a Canadian Phase III human clinical trial for the treatment of moderate to severe psoriasis. In addition, ISA247 has successfully completed a Phase IIa trial for kidney transplantation. The Company also has two additional
immunosuppressive compounds in its drug pipeline, TAFA93 and TKB662 which are in Phase I and pre-clinical respectively. In addition to the Company's drug pipeline, Isotechnika also has a diagnostic division, which includes the Helikit(R) and Diatest(R) breath kits. The Helikit(R) a 13C urea breath test is used for the detection of H. pylori,
a bacterium that infects a large portion of the population. The Diatest(R) a 13C glucose breath test is used to measure insulin resistance. 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.
Forward-Looking Statements
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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.
For further information: Dr. Randall Yatscoff, President & COO, Isotechnika Inc., Phone: (780) 487-1600 Ext. 246, Fax: (780) 484-4105, Email: [email protected];
Stephanie Gillis-Paulgaard, Senior Manager, Corporate Communications, Isotechnika Inc., Phone: (780) 487-1600 Ext. 243, Fax: (780) 484-4105,
E-mail: [email protected];
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