Edmonton, Canada (ots/PRNewswire) - Isotechnika Inc. announced
today that the Company received a No Objection Letter from Health
Canada to conduct a pivotal Phase III European /Canadian clinical
trial for the treatment of moderate to severe psoriasis with its
lead immunosuppressive drug, ISA247. The Company previously received
approval from the German Competent Authority to commence the trial.
The Phase III European/Canadian psoriasis trial (ESSENCE trial)
will be performed at thirty-six clinical centers in Canada, Germany,
and Poland involving a total of 500 patients with moderate to severe
psoriasis. The 24 -week 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 following
the first 12 weeks.
To determine successful completion of the trial, the following
parameters will be measured; Static Physician's Global Assessment
(SPGA) scores, Psoriasis Area and Severity Index (PASI) scores and
"Receipt of the No Objection Letter allows for Canadian
participation in our second Phase III trial for the treatment of
moderate to severe psoriasis," stated Dr. Randall Yatscoff,
Isotechnika's President & CEO. " With approvals granted for the
commencement the Phase III psoriasis trial in both Germany and
Canada we are confident that our development timelines for psoriasis
will be achieved. Patient enrollment for this pivotal trial 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. signed a collaboration agreement with Hoffman La
Roche on April 9, 2002, 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
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
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.presseportal.ch
For further information: Dr. Randall Yatscoff, President & CEO,
Isotechnika Inc., Phone: +1-(780)-487-1600 Ext.246, Fax:
+1-(780)-484-4105, Email: email@example.com; Stephanie
Gillis-Paulgaard, Director, Corporate Communications, Isotechnika
Inc., Phone: +1-(780)-487-1600 Ext. 243, Fax: +1-(780)- 484-4105,