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Isotechnika Inc.

Isotechnika Inc. Reports Interim Results of QTc Trial

Edmonton, Alberta, Canada (ots/PRNewswire)

Isotechnika Inc.
announced today they have received the interim results of the QTc
trial for its lead immunosuppressive drug, ISA247 from eResearch
Technology Inc. The study, conducted by Pracs in Fargo, North Dakota
was designed as a double blind, parallel group, placebo and
moxifloxacin controlled, randomized, single dose QTc study of
trans-ISA247 in healthy volunteers. In accordance with regulatory
guidelines, a time point to time point analysis was also conducted as
a post study exploratory analysis of the trial.
At therapeutic doses of trans-ISA247 (0.5 mg/kg), there were no
ECG changes or QTc signals seen as compared to placebo. At a dose
approximately 11-times higher (4.5 mg/kg) than the expected maximum
dose for the upcoming Phase III psoriasis trials, the interim report
noted that there were no changes in cardiac conduction or morphology.
The time averaged QTc change observed was 13 msec at the 4.5 mg/kg
dose.
"We are extremely encouraged by the results obtained from this
trial indicating that ISA247 shows no evidence of QTc prolongation
when administered at the therapeutic doses," stated Dr. Randall
Yatscoff, Isotechnika's President and COO. "These results will
facilitate the Company filing for a Canadian Phase III psoriasis
trial later this fall."
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 use in
the prevention of organ rejection in transplantation and in the
treatment of autoimmune diseases. Isotechnika looks to become the
leader in development of immunosuppressant therapies.
Isotechnika's lead drug, ISA247, presently referred to as
trans-ISA247, is an immunosuppressant that has successfully completed
a Phase II trial for psoriasis and Phase IIa trial for kidney
transplantation. Isotechnika recently expanded its product pipeline
by developing two additional novel immunosuppressive compounds,
TAFA93 and TKB662. TAFA93 is a novel small molecule mTOR inhibitor, a
class of drugs currently used in the prevention of organ rejection in
transplantation and as a coated stent therapy in the treatment of
coronary artery disease. Pre-clinical studies of TKB662 have
demonstrated inhibition of T cell and B cell activation and
proliferation through multiple mechanisms of action including the
inhibition of lymphocyte phosphorylation activity. As both TAFA93 and
TKB662 have distinct mechanisms of action from calcineurin inhibitors
such as ISA247 they have the potential to be administered as
complementary therapies in both prevention of organ rejection and
treatment of autoimmune diseases.
In addition to the Company's drug pipeline, Isotechnika also has a
diagnostic division, which includes the Helikit(TM) and Diatest(TM)
breath kits. The Helikit(TM), a (13)C breath test is used for the
detection of H.pylori, a bacterium that infects a large portion of
the population. The Helikit(TM) is currently sold internationally.
The Diatest(TM), a (13)C-D glucose breath test is used for the
detection of insulin resistance. The Diatest(TM) is expected to be
made available to primary care physicians in Canada by late 2004. The
Company also expects to commence the necessary clinical trials in
2005 to obtain regulatory approval in the United States and is
working to submit an application to the FDA this year.
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.
Archived images on this organization are available through CNW
E-Pix at http://www.newswire.ca. Images are free to members of The
Canadian Press.  To request a free copy of this organization's annual
report, please go to http://www.newswire.ca and click on reports@cnw.

Contact:

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

Plus de actualités: Isotechnika Inc.
Plus de actualités: Isotechnika Inc.
  • 07.07.2004 – 14:03

    FDA Grants Permission to Isotechnika for TAFA-93 Clinical Trial

    EDMONTON, Canada, July 7 (ots/PRNewswire) - Isotechnika Inc. today announced that the Company has received permission from the Food and Drug Administration of the United States for the commencement of a Phase Ib human clinical trial for TAFA-93. TAFA-93 is a novel prodrug of the mTOR inhibitor rapamycin designed to reduce the unfavourable pharmacokinetics ...

  • 06.07.2004 – 14:13

    Positive Data From Trans-ISA247 Single Ascending Dose Trial

    EDMONTON, Canada, July 6 (ots/PRNewswire) - Isotechnika Inc. (TSX:ISA) announced today the completion of the single ascending dose trial for the Company's lead immunosuppressive drug candidate, ISA247. The SAD trial was conducted in healthy volunteers using the trans-ISA247 formulation to assess the appropriate dosage of the enhanced composition of the drug. The data confirms that the trans formulation of ...