Isotechnika achieves full enrolment for ISA247 Phase 2b kidney transplant trial



    EDMONTON, June 27 /CNW/ - Isotechnika Inc. (TSX:ISA) announced today the
enrolment of the last patient in its Phase 2b trial assessing ISA247 for the
prevention of kidney graft rejection following transplantation. Of the 332
patients enrolled, 148 patients have already completed the required six months
of treatment. The Company expects to have the last patient complete the six
months of active treatment before the end of the year. Furthermore, 43
patients have so far completed an additional 6 months of treatment in the
optional extension phase of this trial. As previously announced, Health Canada
granted a No Objection Letter allowing patients who have already completed 12
months of ISA247 treatment to continue therapy through to commercialization of
the drug.
    "We are very excited to have achieved this significant milestone of
completing enrolment and eagerly await the final results of this trial. Upon
receipt of these results, the Company expects to submit applications to
conduct the pivotal Phase 3 trials that are required for market approval,"
commented Dr. Randall Yatscoff, Isotechnika's President & CEO. "Based on the
improved safety and efficacy profile demonstrated to date we are very
optimistic about the prospects of ISA247 as a leading treatment for kidney
transplant patients. The only two existing drugs in the class of calcineurin
inhibitors share a market size of approximately $2.2 billion annually. We are
therefore encouraged not only by the clinical prospects but also by the market
potential of ISA247 as the only late-stage calcineurin inhibitor currently
under development. "

    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 332 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.
    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.

    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 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 & CEO,
Isotechnika Inc., (780) 487-1600 ext 247, (780) 484-4105 (fax),
ryatscoff@isotechnika.com; Stephanie Gillis-Paulgaard, Director, Corporate
Communications, Isotechnika Inc., (780) 909-4661, (780) 484-4105 (fax),
sgillis-paulgaard@isotechnika.com

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ISOTECHNIKA PHARMA INC.

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