Isotechnika's independent data monitoring committee conducts second review of Phase 2b kidney transplant trial



    Trades on Toronto Stock Exchange - (TSX:ISA)

    EDMONTON, Aug. 22 /CNW/ - Isotechnika Inc. announced today that the
independent data monitoring committee (DMC) has met and reviewed the three
month data from the ongoing Phase 2b kidney transplant (PROMISE) trial. The
review included data from two-thirds of the patients completing three month
treatment. The DMC had no concerns in this review with the outcomes of the
trial to date and recommended that the trial continue as currently designed.
    "As the DMC conducts an independent review of both the trial design and
results we are ensuring that the needs of the patients are being met,"
commented Dr. Yatscoff, Isotechnika's President & CEO. "Their review of the
three month data is in agreement with the previously released interim analysis
suggesting that ISA247 is safe and efficacious in this patient population."

    North American Phase 2b Kidney Transplant Study 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 market leader in North American for transplant drugs called
calcineurin inhibitors. In addition to assessing efficacy, safety measures
including the assessment of various organ functions and clinical laboratory
parameters are monitored throughout 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 and to assess the
relative safety of ISA247 in comparison to the North American leading drug in
transplantation.
    A total of 334 de novo (newly transplanted) kidney transplant patients
have been 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 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 will
receive 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 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.
    Calcineurin inhibitors are used in the vast majority of all transplant
patients from the time of transplant, continuing for the entire life of the
patient. The market for these drugs currently exceeds $2 billion annually. Use
of the only other two marketed calcineurin inhibitors, cyclosporin and
tacrolimus, while both efficacious, is associated with various significant
safety drawbacks.
    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.

    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.

    %SEDAR: 00010508E




For further information:

For further information: Dr. Randall Yatscoff, President & COO,
Isotechnika Inc., Phone: (780) 487-1600 Ext. 246, Fax: (780) 484-4105, Email:
ryatscoff@isotechnika.com; Stephanie Gillis-Paulgaard, Director, Corporate
Communications, Isotechnika Inc., Phone: (780) 487-1600 Ext. 243, Fax: (780)
484-4105, E-mail:sgillis-paulgaard@isotechnika.com

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ISOTECHNIKA PHARMA INC.

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