Isotechnika Inc.

Isotechnika Inc. receives No Objection Letter from Health Canada for Phase III Psoriasis Trial

    Edmonton, Alberta (ots/PRNewswire) - Isotechnika Inc. announced today that the Company received a No  Objection Letter from Health Canada for the commencement of a Phase III  trial for its lead immunosuppressive drug candidate, ISA247.

    The trial will be performed over a twenty-four week period at thirty-  three centers across Canada involving a total of 400 subjects with severe  psoriasis. It will be conducted as a randomized, double-blind study with  100 subjects receiving the high dose (0.4 mg/kg twice daily), 100 subjects  receiving the anticipated therapeutic dose (0.3 mg/kg twice daily),  100 subjects receiving the low dose (0.2 mg/kg twice daily) and 100  subjects receiving placebo. In an effort to maximize the benefit to those  enrolled in the study who may receive placebo for the first 12 week period  they will be administered a dose of 0.3 mg/kg twice daily commencing the  13th week of the study. All doses of drug will be administered as soft gelatine capsules administered orally.

    Successful completion of the trial will be determined by the proportion  of subjects who achieve a 75% reduction in the psoriasis area and severity  index (PASI). Secondary endpoints of the trial include maintenance of  stable kidney function and assessment of quality of life. Blood specimens  will also be collected periodically to gather additional pharmacokinetic  and pharmacodynamic (PK/PD) data.

    "Moving ISA247 into Phase III has been the Company's primary focus over  the last year," stated Dr. Randall Yatscoff, Isotechnika's President and &  COO. "Receipt of the No Objection Letter allows us to meet the drug  development timelines set for ISA247 and establish Isotechnika as a Phase  III company. Manufacturing of the drug supply was completed in an efficient  and cost-effective manner."

    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  glucose breath test is used for the detection of insulin resistance. The  Company expects to commence the necessary clinical trials in 2005 involving the Diatest(TM) to obtain regulatory approval in the United States.

    Isotechnika Inc. is a publicly traded company on the Toronto Stock Exchange under the symbol ISA. More information on Isotechnika can be found  at

    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.

ots Originaltext: Isotechnika Inc.
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For further information: Dr. Randall Yatscoff, President & COO,
Isotechnika Inc., Phone: +1(780)-487-1600 Ext.246, Fax:
+1-(780)-484-4105, Email:; Stephanie
Gillis-Paulgaard, Manager, Corporate Communications, Isotechnika
Inc., Phone: +1(780)-487-1600 Ext. 243, Fax: +1-(780)-484-4105,

Weitere Meldungen: Isotechnika Inc.

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