- 02.10.2006, 15:15:42
- /
- OTE0004
Isotechnika Receives Approval From the German Competent Authority for a Pivotal Phase III Psoriasis Clinical Trial
Edmonton, Canada (ots/PRNewswire) - Isotechnika Inc. announced
today that the Company received approval from the German Competent
Authority to conduct a pivotal Phase III clinical trial for the
treatment of moderate to severe psoriasis with its lead
immunosuppressive drug, ISA247.
The Phase III European/Canadian psoriasis trial (ESSENCE trial)
will be performed over a 24 week period at a total of thirty-six
centers in Germany, Poland and Canada involving a total of 500
patients with moderate to severe psoriasis. The trial will be
conducted as a randomized, orally administered placebo and
cyclosporine controlled study with 300 patients receiving ISA247
(0.4 mg/kg twice daily), 100 patients receiving cyclosporine (1.5
mg/kg twice daily), and 100 patients receiving placebo. In an effort
to maximize the benefit to patients enrolled in the placebo group
ISA247 will be administered at a dose of 0.4 mg/kg twice daily
following the first 12 weeks.
Successful completion of the trial will be determined by the
following endpoints;
Primary endpoint
- superiority in the proportion of subjects achieving a score of
"clear" or "almost clear" in the Static Physician's Global Assessment
(SPGA) score at 12 weeks in the ISA247 treatment group compared to
placebo control.
Secondary endpoints
-------------------
- non-inferiority of ISA247 compared to cyclosporine control in the
proportion of subjects achieving a score of "clear" or "almost clear"
in the Static Physician's Global Assessment (SPGA) score at 12 weeks;
- a 75% reduction in the Psoriasis Area and Severity Index (PASI) score
at 12 weeks of ISA247 versus placebo; and
- maintenance of stable kidney function."Moving our late-stage clinical development plan for ISA247
forward in psoriasis and kidney transplantation continues to be our
primary focus," stated Dr. Randall Yatscoff, Isotechnika's President
& CEO. "Following our first phase III psoriasis trial approval and
subsequent completion in Canada, this second phase III approval for
moderate to severe psoriasis now allows us the opportunity to expand
our trials into Europe. In anticipation of this approval, clinical
trial sites have been selected. Patient enrollment will commence
later this 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 has completed an extension
protocol of a Canadian Phase III human clinical trial for the
treatment of moderate to severe psoriasis and a North American Phase
IIb human clinical trial for the prevention of kidney graft
rejection. The Company also has an additional immunosuppressive
compound in its drug pipeline, TAFA93 which successfully completed
Phase I clinical trials.
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. has a collaboration agreement with Hoffman La
Roche 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.
Rückfragehinweis:
For further information: Dr. Randall Yatscoff, President & CEO,
Isotechnika Inc., Phone: +1-(780)-487-1600 Ext. 246, Fax:
+1-(780)-484-4105, Email: [email protected]; Stephanie
Gillis-Paulgaard, Director, Corporate Communications, Isotechnika
Inc., Phone: +1-(780)-487-1600 Ext. 243, Fax: +1-(780)-484-4105,
E-mail:[email protected]
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