Edmonton, Alberta (ots/PRNewswire) - Isotechnika Inc. announced
today that the Company has received permission from the Food and Drug
Administration of the United States to proceed with a Phase IIb
kidney transplant trial for its lead immunosuppressive drug, ISA247.
The planned randomized, open-label trial will include
approximately 332 de novo (newly transplanted) kidney patients from
clinical trial sites across North America. The Company previously
received a No Objection Letter from Health Canada on April 28, 2005
to begin the Phase IIb kidney transplant trial.
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 receive permission from the FDA to
conduct this Phase IIb trial as it validates the bridging studies
performed by the Company last year. As a result of changing the
manufacturing to the trans-ISA247, it was necessary to complete a
number of bridging studies prior to filing for regulatory approval to
commence the Phase IIb trial," stated Dr. Randall Yatscoff,
Isotechnika's President & COO. "Our goal, subject to available
financial resources, is to commence North American site selection and
patient recruitment by the end of the current 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
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 (13)C 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.
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.
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ots Originaltext: Isotechnika Inc.
Im Internet recherchierbar: http://www.presseportal.ch
For further information: Dr. Randall Yatscoff, President & COO,
Isotechnika Inc., Phone: +1-780-487-1600 Ext. 246, Fax:
+1-780-484-4105, Email: email@example.com; Stephanie
Gillis-Paulgaard, Senior Manager, Corporate Communications,
Isotechnika Inc., Phone: +1-780-909-4661, Fax: +1-780-484-4105,