Edmonton, Alberta (ots/PRNewswire)
- Isotechnika Inc. announced
today that the Company received a No Objection Letter from Health
Canada for the commencement of a Phase III trial for its lead
immunosuppressive drug candidate, ISA247.
The trial will be performed over a twenty-four week period at
thirty- three centers across Canada involving a total of 400
subjects with severe psoriasis. It will be conducted as a
randomized, double-blind study with 100 subjects receiving the high
dose (0.4 mg/kg twice daily), 100 subjects receiving the anticipated
therapeutic dose (0.3 mg/kg twice daily), 100 subjects receiving the
low dose (0.2 mg/kg twice daily) and 100 subjects receiving placebo.
In an effort to maximize the benefit to those enrolled in the study
who may receive placebo for the first 12 week period they will be
administered a dose of 0.3 mg/kg twice daily commencing the 13th
week of the study. All doses of drug will be administered as soft
gelatine capsules administered orally.
Successful completion of the trial will be determined by the
proportion of subjects who achieve a 75% reduction in the psoriasis
area and severity index (PASI). Secondary endpoints of the trial
include maintenance of stable kidney function and assessment of
quality of life. Blood specimens will also be collected periodically
to gather additional pharmacokinetic and pharmacodynamic (PK/PD)
"Moving ISA247 into Phase III has been the Company's primary focus
over the last year," stated Dr. Randall Yatscoff, Isotechnika's
President and & COO. "Receipt of the No Objection Letter allows us
to meet the drug development timelines set for ISA247 and establish
Isotechnika as a Phase III company. Manufacturing of the drug supply
was completed in an efficient and cost-effective manner."
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 glucose breath test is used for the
detection of insulin resistance. The Company expects to commence the
necessary clinical trials in 2005 involving the Diatest(TM) to obtain
regulatory approval in the United States.
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.
ots Originaltext: Isotechnika Inc.
Im Internet recherchierbar: http://www.newsaktuell.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
Gillis-Paulgaard, Manager, Corporate Communications, Isotechnika
Inc., Phone: +1(780)-487-1600 Ext. 243, Fax: +1-(780)-484-4105,