Isotechnika Inc.

Isotechnika Receives No Objection Letter From Health Canada for Second Phase III Psoriasis Clinical Trial

    Edmonton, Canada (ots/PRNewswire) - Isotechnika Inc. announced today that the Company received a No  Objection Letter from Health Canada to conduct a pivotal Phase III European /Canadian clinical trial for the treatment of moderate to severe psoriasis  with its lead immunosuppressive drug, ISA247. The Company previously  received approval from the German Competent Authority to commence the trial.

    The Phase III European/Canadian psoriasis trial (ESSENCE trial) will be  performed at thirty-six clinical centers in Canada, Germany, and Poland  involving a total of 500 patients with moderate to severe psoriasis. The 24 -week 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 following the first 12 weeks.

    To determine successful completion of the trial, the following parameters will be measured; Static Physician's Global Assessment (SPGA)  scores, Psoriasis Area and Severity Index (PASI) scores and kidney function.

    "Receipt of the No Objection Letter allows for Canadian participation  in our second Phase III trial for the treatment of moderate to severe  psoriasis," stated Dr. Randall Yatscoff, Isotechnika's President & CEO. " With approvals granted for the commencement the Phase III psoriasis trial  in both Germany and Canada we are confident that our development timelines  for psoriasis will be achieved. Patient enrollment for this pivotal trial 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. 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 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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