Isotechnika Inc.

Health Canada Allows Isotechnika to Continue Patients on ISA247 Until Commercialization

    Edmonton, Canada (ots/PRNewswire) -

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


    Isotechnika today announced that the Company has received a No Objection Letter from Health Canada for the long term use of ISA247 in patients currently participating in the Canadian arm of the Company's Phase 2b kidney transplant trial.

    The No Objection Letter allows patients to remain on ISA247 through to commercialization of the drug and beyond after completion of the 12 month Phase 2b trial. Patients choosing to remain on ISA247 therapy will continue to have safety and efficacy parameters monitored on an ongoing basis. A similar protocol amendment for the long term use of ISA247 has also been submitted to the Food and Drug Administration of the United States.

    "We submitted the protocol amendment for the long term use of ISA247 after receiving numerous requests from investigators and patients currently involved in our kidney transplant trial," said Dr. Randall Yatscoff, Isotechnika's President & Chief Executive Officer. Dr. Yatscoff added, "Transplant patients are required to remain on immunosuppressive therapies  for the rest of their lives. It is expected that the majority of our patients will choose to continue the use of ISA247. We are excited that our patients have the opportunity to continue on ISA247 which should make a real difference in the quality of their lives."

    North American Phase 2b Kidney Transplant Trial Design

    Forty-two centers across North America have been contracted to perform  the trial, including thirty-eight centers in the United States and four  centers in Canada. The primary endpoint of the trial is defined as non- inferiority in biopsy proven acute rejection (BPAR) episodes in patients  receiving ISA247 for six months as compared to the tacrolimus control which  is currently the North American leading transplant drug in this class.  Additionally, kidney function and other laboratory parameters will be  monitored for the duration of the trial. The overall goal of the trial is to  find the most appropriate dose that will result in efficacy (lack of acute rejection) with minimal side effects that are typically seen with other  calcineurin inhibitors such as cyclosporine and tacrolimus.

    A total of 332 de novo (newly transplanted) kidney transplant patients  will be enrolled in this trial. Patients will be placed into one of four  separate treatment groups; three different dose groups of ISA247 (0.4 mg/kg,  0.6 mg/kg, and 0.8 mg/kg twice daily) compared with the fourth group, a  tacrolimus (0.05 mg/kg twice daily) control arm. Patients in all four  treatment groups will have their doses adjusted in order to achieve pre- defined blood levels of either ISA247 or tacrolimus. All patients will  receive oral treatment of drug (ISA247 or tacrolimus) over a six month period along with other standard immunosuppressive therapies used following transplantation. Patients completing the six month trial will be given the  option to continue therapy for an additional six months. The objective is to  gather long term safety and efficacy data in de novo transplant patients.

    About Isotechnika

    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 (with Hoffman La Roche)  and treatment of autoimmune disorders such as uveitis (with Lux Biosciences)  and psoriasis.

    There is a significant unmet medical need in the  treatment of both  solid organ transplantation and autoimmune disease. It is estimated that  the market potential exceeds CDN$2 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 Phase 3 European/Canadian psoriasis trial  and a Phase 2b North American trial for the prevention of kidney graft  rejection subsequent to transplantation.

    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 & 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: +1-780-909-4661, Fax: +1-780-484-4105, E-mail:

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