Isotechnika Inc. Reports Interim Results of QTc Trial
Edmonton, Alberta, Canada (ots/PRNewswire)
Isotechnika Inc. announced today they have received the interim results of the QTc trial for its lead immunosuppressive drug, ISA247 from eResearch Technology Inc. The study, conducted by Pracs in Fargo, North Dakota was designed as a double blind, parallel group, placebo and moxifloxacin controlled, randomized, single dose QTc study of trans-ISA247 in healthy volunteers. In accordance with regulatory guidelines, a time point to time point analysis was also conducted as a post study exploratory analysis of the trial.
At therapeutic doses of trans-ISA247 (0.5 mg/kg), there were no ECG changes or QTc signals seen as compared to placebo. At a dose approximately 11-times higher (4.5 mg/kg) than the expected maximum dose for the upcoming Phase III psoriasis trials, the interim report noted that there were no changes in cardiac conduction or morphology. The time averaged QTc change observed was 13 msec at the 4.5 mg/kg dose.
"We are extremely encouraged by the results obtained from this trial indicating that ISA247 shows no evidence of QTc prolongation when administered at the therapeutic doses," stated Dr. Randall Yatscoff, Isotechnika's President and COO. "These results will facilitate the Company filing for a Canadian Phase III psoriasis trial later this fall."
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 use in the prevention of organ rejection in transplantation and in the treatment of autoimmune diseases. Isotechnika looks to become the leader in development of immunosuppressant therapies.
Isotechnika's lead drug, ISA247, presently referred to as trans-ISA247, is an immunosuppressant that has successfully completed a Phase II trial for psoriasis and Phase IIa trial for kidney transplantation. Isotechnika recently expanded its product pipeline by developing two additional novel immunosuppressive compounds, TAFA93 and TKB662. TAFA93 is a novel small molecule mTOR inhibitor, a class of drugs currently used in the prevention of organ rejection in transplantation and as a coated stent therapy in the treatment of coronary artery disease. Pre-clinical studies of TKB662 have demonstrated inhibition of T cell and B cell activation and proliferation through multiple mechanisms of action including the inhibition of lymphocyte phosphorylation activity. As both TAFA93 and TKB662 have distinct mechanisms of action from calcineurin inhibitors such as ISA247 they have the potential to be administered as complementary therapies in both prevention of organ rejection and treatment of autoimmune diseases.
In addition to the Company's drug pipeline, Isotechnika also has a diagnostic division, which includes the Helikit(TM) and Diatest(TM) breath kits. The Helikit(TM), a (13)C breath test is used for the detection of H.pylori, a bacterium that infects a large portion of the population. The Helikit(TM) is currently sold internationally. The Diatest(TM), a (13)C-D glucose breath test is used for the detection of insulin resistance. The Diatest(TM) is expected to be made available to primary care physicians in Canada by late 2004. The Company also expects to commence the necessary clinical trials in 2005 to obtain regulatory approval in the United States and is working to submit an application to the FDA this year.
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
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.
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Contact:
For further information: Dr. Randall Yatscoff, President & COO,
Isotechnika Inc., Phone: +1-(780)-487-1600 extension 246, Fax:
+1-(780)-484-4105, Email: ryatscoff@isotechnika.com; Stephanie
Gillis-Paulgaard, Manager, Corporate Communications, Isotechnika
Inc., Phone: +1-(780)-487-1600 extension 243, Fax: +1-(780)-484-4105,
E-mail: sgillis-paulgaard@isotechnika.com