Health Canada allows Isotechnika to continue patients on ISA247 until commercialization



    Trades on Toronto Stock Exchange - (TSX:ISA)
    www.isotechnika.com

    EDMONTON, June 7 /CNW/ - 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 $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 www.isotechnika.com.

    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.

    %SEDAR: 00010508E




For further information:

For further information: Dr. Randall Yatscoff, President & CEO,
Isotechnika Inc., Phone: (780) 487-1600 Ext. 247, Fax: (780) 484-4105, Email:
ryatscoff@isotechnika.com; Stephanie Gillis-Paulgaard, Director, Corporate
Communications, Isotechnika Inc., Phone: (780) 909-4661, Fax: (780) 484-4105,
E-mail: sgillis-paulgaard@isotechnika.com

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ISOTECHNIKA PHARMA INC.

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