Isotechnika Inc.

Isotechnika Receives Approval From Polish Competent Authority for Pivotal Phase 3 Psoriasis Clinical Trial

    Edmonton, Canada (ots/PRNewswire) -

    - Trades on Toronto Stock Exchange - (TSX:ISA)

    Isotechnika Inc. announced today that the Company received approval from  the Polish Competent Authority for participation in the ongoing Phase 3  European/Canadian clinical trial. This trial investigates the use of ISA247  in patients suffering from moderate to severe psoriasis. The Company  previously received approval from the German Competent Authority and Health  Canada to commence the trial. At present, a total of 283 patients have been  enrolled in Germany and Canada.

    "The addition of twelve clinical trial sites in Poland allows others to  gain experience with ISA247 for the treatment of psoriasis and further  broadens our investigator base. Addition of these sites, to the twenty-nine  sites already established in Germany and Canada, should facilitate us meeting  our expected recruitment timelines for this trial," stated Dr. Randall  Yatscoff, Isotechnika's President & CEO. "Patient enrolment in Poland is  expected to commence immediately."

    Phase 3 European/Canadian Trial Design

    The Phase 3 European/Canadian psoriasis trial (ESSENCE) will be performed  at forty-one clinical centers in Canada, Germany, and Poland. The 24-week  trial is being conducted as a randomized, orally administered placebo and cyclosporine controlled trial. To maximize the benefit to patients enrolled  in the placebo group, all patients randomized to the placebo group will  receive active treatment with ISA247 beginning after 12 weeks of placebo  dosing.

    To determine successful completion of the trial, the following efficacy parameters will be measured: Static Physician's Global Assessment (SPGA)  scores, Psoriasis Area and Severity Index (PASI) scores. Safety parameters  will also be monitored by measuring the prevalence of adverse events,  including altered kidney function.

    About Isotechnika Inc.

    Edmonton-based Isotechnika Inc. is an international biopharmaceutical  company focused on the discovery and development of novel immunosuppressive  therapeutics that are designed to offer advantages over other currently  available treatments while offering therapeutic choices to clinicians.  Isotechnika looks to become the market leader of drug therapies for  indications such as transplantation of solid organs and treatment of  autoimmune disorders such as psoriasis.

    There is a significant unmet medical need in both solid organ transplantation and autoimmune disease. It is estimated that the market  potential far exceeds $1 billion annually in sales for calcineurin inhibitors  such as ISA247.

    Isotechnika's lead drug, ISA247, has successfully completed a Phase 3  Canadian trial for the treatment of moderate to severe psoriasis. ISA247 is  currently being investigated in a combined Phase 3 European/Canadian  psoriasis trial and a Phase 2b North American trial for the prevention of  kidney graft rejection. One of our partners, Lux Biosciences, has received  permission from the regulatory bodies in Austria, Canada, France, Germany,  India, the United Kingdom and the United States to investigate ISA247 in  three separate pivotal Phase 2/Phase 3 trials for the treatment of non- infectious uveitis and as a maintenance therapy in uveitis.

    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. signed a collaboration agreement with Hoffman La Roche  on April 9, 2002, 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 medical 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 all forms of 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. 247, 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, E-mail:

Weitere Meldungen: Isotechnika Inc.

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