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Isotechnika Inc.

Isotechnika Receives No Objection Letter From Health Canada for Phase IIb Kidney Transplant Trial

Edmonton, Canada (ots/PRNewswire)

Isotechnika Inc. announced
today that the Company received a No Objection Letter from Health
Canada for the commencement of a Phase IIb kidney transplant trial
for its lead immunosuppressive drug, ISA247.
This randomized, open-label trial will include approximately 332
de novo (newly transplanted) kidney patients. Patients will be placed
into one of four separate dosing groups. The four dosing groups will
be comprised of three different targeted blood concentrations of
ISA247 compared with the fourth group, a tacrolimus control arm. All
patients will receive twice daily oral treatment of drug over a 24
week period. Treatment will commence at the time of transplant
surgery.
The primary endpoint of the trial is defined as non-inferiority in
biopsy proven acute rejection (BPAR) episodes with patients receiving
ISA247 for six months as compared to tacrolimus. Additionally,
patient's kidney function and other laboratory parameters such as
hypertension, hyperlipidemia and new onset diabetes mellitus will be
monitored for the duration of the trial.
"We are extremely pleased to have received the No Objection Letter
for this trial in de novo transplant patients as this will facilitate
the continuation of our advanced clinical program in transplantation.
Based on our previously successful Phase IIa kidney transplant trial
in stable patients where we met our efficacy and safety endpoints, we
believe that this Phase IIb trial should also be successful," stated
Dr. Randall Yatscoff, Isotechnika's President & COO. "The company
will commence clinical trial site selection in the near future with
patient recruitment to begin by the end of the year."
About Isotechnika Inc.
Isotechnika Inc. is an international biopharmaceutical company
headquartered in Edmonton, Alberta, Canada. Drawing upon its
expertise in medicinal chemistry and immunology, the Company is
focused on the discovery and development of novel immunosuppressive
therapeutics that are safer than currently available treatments. Its
entrepreneurial management and world-class team of scientists are
building a pipeline of immunosuppressive drug candidates for
treatment of autoimmune diseases and for use in the prevention of
organ rejection in transplantation. Isotechnika looks to become the
leader in development of immunosuppressant therapies.
Isotechnika's lead compound, ISA247 is an immunosuppressant
currently in a Canadian Phase III human clinical trial for the
treatment of moderate to severe psoriasis. In addition, ISA247 has
successfully completed a Phase IIa trial for kidney transplantation.
The Company also has two additional immunosuppressive compounds in
its drug pipeline, TAFA93 and TKB662 which are in Phase I and
pre-clinical respectively.
In addition to the Company's drug pipeline, Isotechnika also has a
diagnostic division, which includes the Helikit(R) and Diatest(R)
breath kits. The Helikit(R) a 13C urea breath test is used for the
detection of H. pylori, a bacterium that infects a large portion of
the population. The Diatest(R) a 13C glucose breath test is used to
measure insulin resistance.
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.
To request a free copy of this organization's annual report,
please go to http://www.newswire.ca and click on reports@cnw.
Archived images on this organization are searchable through CNW
Photo Archive website at http://photos.newswire.ca. Images are free
to accredited members of the media.

Contact:

For further information: Dr. Randall Yatscoff, President & COO,
Isotechnika Inc., Phone: +1-(780)-487-1600 Ext. 246, Fax:
+1-(780)-484-4105, Email: ryatscoff@isotechnika.com; Stephanie
Gillis-Paulgaard, Senior Manager, Corporate Communications,
Isotechnika Inc., Phone: +1-(780)-487-1600 Ext. 243, Fax:
+1-(780)-484-4105, E-mail: sgillis-paulgaard@isotechnika.com

Plus de actualités: Isotechnika Inc.
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  • 25.04.2005 – 14:06

    Isotechnika Announces Preliminary Phase III Psoriasis Results

    Edmonton, Canada (ots/PRNewswire) - Isotechnika Inc. announced today that the Canadian Phase III psoriasis trial for its lead immunosuppressive drug, ISA247, continues to show promising results. The Canadian Phase III Psoriasis trial (SPIRIT) which commenced on December 2, 2004, includes a total of 453 patients with stable moderate to severe plaque psoriasis. The trial is currently being conducted in 32 sites and ...

  • 06.04.2005 – 14:11

    Isotechnika Receives U.S. Patent for Insulin Resistance Diagnostic Test

    Edmonton, Canada (ots/PRNewswire) - Isotechnika Inc. (TSX: ISA) announced today that the Company has been issued U.S. Patent No. 6,878,550 for its diagnostic breath test kit, Diatest(R). The patent entitled "13C Glucose Breath Test for the Diagnosis of Diabetic Indications and Monitoring Glycemic Control" is the fifth U.S. Patent issued for this technology. ...

  • 10.02.2005 – 21:30

    Isotechnika Achieves Target Enrolment for Phase III Psoriasis Trial

    Edmonton, Canada (ots/PRNewswire) - Isotechnika Inc. announced today that the original target of 400 subjects for its Canadian Phase III psoriasis trial for its lead immunosuppressive compound, ISA247 has been reached. Due to the enthusiasm of our investigators and the willingness of patients to participate in the trial, the Company will allow approximately 80 ...