Last patient in Isotechnika's phase 2b kidney transplant trial completes six month treatment



    EDMONTON, Jan. 3 /CNW/ - Isotechnika Inc. (TSX:ISA) announced today that
the last patient enrolled in the Company's Phase 2b kidney transplant trial
has completed the six month trial.
    "The six month data is expected to be available in the second quarter of
this year," stated Dr. Robert Foster, Isotechnika's Chairman & CEO. "We
believe that the final data will confirm ISA247 as an efficacious treatment
for kidney transplant patients with an enhanced safety profile over current
calcineurin inhibition therapies. Efficacy and enhanced safety profile will be
key characteristics of the next generation of calcineurin inhibitors and
ensure that calcineurin inhibition remains the foundation of evidence based
medicine."
    Patients who have completed the six months trial were provided the
opportunity to continue treatment with ISA247 as part of an extension to the
initial trial. This six month extension period will provide longer term safety
and efficacy data for the drug in de novo kidney transplant patients.
    On June 7, 2007 and August 2, 2007, Isotechnika received permission from
Health Canada and from the Food and Drug Administration, respectively, to
allow patients to remain on ISA247 until the drug is commercially available.

    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 leading North American 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. The use of the other two calcineurin
inhibitors, cyclosporin and tacrolimus, are often associated with significant
safety concerns.
    A total of 334 de novo (newly transplanted) kidney transplant patients
have been enrolled in this trial. Patients were 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 control arm (0.05 mg/kg twice daily). 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 received
oral dosing with the drug (ISA247 or tacrolimus) over a six month period along
with other standard immunosuppressive therapies used following
transplantation.

    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. 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.
    ISA247 is currently being investigated in a Phase 2b North American trial
for the prevention of kidney graft rejection subsequent to transplantation and
a Phase 3 European/Canadian psoriasis trial.
    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.

    
    Partnerships with Isotechnika Inc.

    -   Roche retains an option to continue development of the transplant
        indications based on the successful completion of the ongoing Phase
        2b kidney transplant trial.
    -   Atrium Medical Corporation has exclusive worldwide licensing
        agreement for use of ISA247 and TAFA93 with drug eluting devices for
        non-systemic treatment of vascular, cardiovascular, target vessel and
        tissue disorders.
    -   Lux Biosciences Inc. was granted worldwide rights to develop and
        commercialize 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.

    %SEDAR: 00010508E




For further information:

For further information: Dr. Robert Foster, Chairman & CEO, Isotechnika
Inc., Phone: (780) 487-1600 (x247), Fax: (780) 484-4105, E-mail:
rfoster@isotechnika.com; Stephanie Gillis-Paulgaard, Director, Corporate
Communications, Isotechnika Inc., Phone: (780) 487-1600 (x243), Fax: (780)
484-4105, E-mail: sgillis-paulgaard@isotechnika.com

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ISOTECHNIKA PHARMA INC.

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