FDA allows long term use of ISA247 in Isotechnika Phase 2b kidney transplant trial



    EDMONTON, Aug. 2 /CNW/ - Isotechnika today announced that the Company has
received permission from the Food and Drug Administration of the United States
(FDA) for the long term use of ISA247 in patients currently participating in
the Company's Phase 2b kidney transplant (PROMISE) trial. The Company
previously announced in June that it had also received a No Objection Letter
from Health Canada for the long term use of ISA247 in this trial.
    Patients involved in the PROMISE trial are allowed to remain on ISA247
through to commercialization of the drug and beyond after completion of the 12
month trial. Patients choosing to remain on ISA247 therapy will continue to
have safety and efficacy parameters monitored on an ongoing basis.
    "With this approval from the FDA along with the previously received
approval from Health Canada all patients enrolled in the PROMISE trial will
have the opportunity to continue on ISA247 for the long term," stated Dr.
Randall Yatscoff, Isotechnika's President & CEO. "It is our belief that by
having patients continue to receive ISA247 therapy we are contributing to an
improved quality of life subsequent to transplantation. The long term data
received from these patients will facilitate ISA247 achieving its commercial
potential."

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

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ISOTECHNIKA PHARMA INC.

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