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Isotechnika Completes Recruitment for Phase III Psoriasis Trial
Edmonton, Canada (ots/PRNewswire) - Isotechnika Inc. announced today that the Company has completed recruitment for its Canadian Phase III psoriasis trial for its lead immunosuppressive compound, ISA247. Of the 400 subjects enrolled in the trial, 207 subjects have commenced treatment.
The Company received a "No Objection Letter" from Health Canada on December 1, 2004 and commenced the trial on December 2, 2004. The Phase III trial will be performed over a twenty-four week period at thirty-two centres across Canada involving subjects with moderate to severe psoriasis. It will be conducted as a randomised, double-blind study with four dose arms. Of the 400 subjects, 100 subjects will receive the high dose (0.4 mg/kg twice daily), 100 subjects will receive the mid dose (0.3 mg/kg twice daily), 100 subjects will receive the low dose (0.2 mg/kg twice daily) and 100 subjects will receive placebo. Subsequent to the first 12 weeks, those subjects who received placebo will move into the mid dose range dose of 0.3 mg/kg twice daily for the remaining 12 weeks of the study.
"We are pleased that our recruitment has been completed in just two months," stated Dr. Randall Yatscoff, Isotechnika's President and Chief Operating Officer. "This indicates an unmet medical need for people suffering from this debilitating disease. Isotechnika will continue to focus its resources on advancing ISA247 for the treatment of psoriasis."
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 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. The Company also has two additional immunosuppressive compounds in its drug pipeline, TAFA93 and TKB662. Both compounds are in early stage clinical development, Phase I and pre-clinical respectively.
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 Diatest(TM), a (13)C 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.
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 commercialise 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.
ots Originaltext: Isotechnika Inc.
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Dr. Randall Yatscoff, President & COO, Isotechnika Inc., Phone:
+1-780-487-1600 Ext.246, Fax: +1-780-484-4105, Email:
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Manager, Corporate Communications & Investor Relations, Isotechnika
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