Isotechnika Inc.

Isotechnika Receives Approval From the German Competent Authority for a Pivotal Phase III Psoriasis Clinical Trial

    Edmonton, Canada (ots/PRNewswire) - Isotechnika Inc. announced today that the Company received approval  from the German Competent Authority to conduct a pivotal Phase III clinical  trial for the treatment of moderate to severe psoriasis with its lead immunosuppressive drug, ISA247.

    The Phase III European/Canadian psoriasis trial (ESSENCE trial) will  be performed over a 24 week period at a total of thirty-six centers in  Germany, Poland and Canada involving a total of 500 patients with moderate  to severe psoriasis. The trial will be conducted as a randomized, orally  administered placebo and cyclosporine controlled study with 300 patients  receiving ISA247 (0.4 mg/kg twice daily), 100 patients receiving  cyclosporine (1.5 mg/kg twice daily), and 100 patients receiving placebo.  In an effort to maximize the benefit to patients enrolled in the placebo  group ISA247 will be administered at a dose of 0.4 mg/kg twice daily following the first 12 weeks.

    Successful completion of the trial will be determined by the following  endpoints;

@@start.t1@@        Primary endpoint
        -  superiority in the proportion of subjects achieving a score of
            "clear" or "almost clear" in the Static Physician's Global Assessment
            (SPGA) score at 12 weeks in the ISA247 treatment group compared to
            placebo control.
        Secondary endpoints
        -  non-inferiority of ISA247 compared to cyclosporine control in the
            proportion of subjects achieving a score of "clear" or "almost clear"
            in the Static Physician's Global Assessment (SPGA) score at 12 weeks;
        -  a 75% reduction in the Psoriasis Area and Severity Index (PASI) score
            at 12 weeks of ISA247 versus placebo; and
        -  maintenance of stable kidney function.@@end@@

    "Moving our late-stage clinical development plan for ISA247 forward in  psoriasis and kidney transplantation continues to be our primary focus,"  stated Dr. Randall Yatscoff, Isotechnika's President & CEO. "Following our  first phase III psoriasis trial approval and subsequent completion in  Canada, this second phase III approval for moderate to severe psoriasis now  allows us the opportunity to expand our trials into Europe. In anticipation  of this approval, clinical trial sites have been selected. Patient  enrollment will commence later this year."

    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 has completed an extension protocol of a Canadian Phase III human clinical trial for the treatment of  moderate to severe psoriasis and a North American Phase IIb human clinical  trial for the prevention of kidney graft rejection. The Company also has an  additional immunosuppressive compound in its drug pipeline, TAFA93 which  successfully completed Phase I clinical trials.

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

    Partnerships with Isotechnika Inc.


    Isotechnika Inc. has a collaboration agreement with Hoffman La Roche  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.

ots Originaltext: Isotechnika Inc.
Im Internet recherchierbar:

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

Weitere Meldungen: Isotechnika Inc.

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