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Isotechnika Inc.

Isotechnika Announces Interim Blinded Phase III Psoriasis Results

Edmonton, Canada (ots/PRNewswire)

Isotechnika Inc. (TSX: ISA)
announced today that the Canadian Phase III  psoriasis trial for its
lead immunosuppressive drug, ISA247, continues to  demonstrate a
promising safety and efficacy profile.
The Canadian Phase III Psoriasis (SPIRIT) trial commenced on
December 2, 2004 and includes a total of 453 patients with stable
moderate to severe plaque psoriasis. The trial is currently being
conducted at 32 sites over a 24 week period and is the largest of its
kind in Canada using an orally administered systemic medication in
psoriasis. This randomized, double-blind, trial examines the efficacy
of 3 dosing groups of ISA247 (0.2 mg/kg, 0.3 mg/kg and 0.4 mg/kg
twice daily) compared to placebo with equal numbers of patients
assigned to each of the four treatment groups. Subsequent to the
first 12 weeks, those patients who received placebo were administered
the mid-dose of 0.3 mg/kg twice daily for the remaining 12 weeks of
the study. Patients already receiving active treatment (ISA247)
remained in their respective dosing groups for the final 12 weeks of
the trial.
Based on blinded data from 369 patients treated with either ISA247
or placebo for at least 12 weeks, the mean decrease in Psoriasis Area
and Severity Index (PASI) scores for all four treatment groups
combined (including the placebo group) was 38%. The blinded data has
also indicated a good safety profile. The highest mean change in
serum creatinine at 12 weeks in any of the dosing groups was 5.6%
above baseline which is within normal analytical and physiological
variation. After 12 weeks of treatment, a total of five patients
which represents less than 2% of the 369 patients were withdrawn from
the trial due to a clinically significant effect on kidney function.
"I am extremely pleased with the safety and efficacy results of
the blinded data. These results are in line with what we expected
based on the results of our previous successful Phase II trial,"
stated Dr. Randall Yatscoff, Isotechnika's President and COO. "Based
on the blinded data to date we are confident we will show a
clinically and statistically significant difference in the number of
patients achieving a 75% decrease in the PASI score at 12 weeks when
compared to placebo when the results are unblinded later this fall.
We expect to achieve this with minimal impact on kidney function."
Dr. Charles Lynde, a principal investigator involved in the trial
and past president of the Canadian Dermatology Association stated,
"The study is blinded; however, clinically there is a sub group that
has done extremely well with marked PASI reductions, many becoming
completely clear after 8-12 weeks of therapy. Overall side effects
are at a minimum with little blood pressure elevation or creatinine
clearance disturbance seen. This is in contradiction to cyclosporine
where blood pressure elevations and creatinine clearance are often a
problem."
"Earlier this year an independent data monitoring committee (DMC)
was formed as a special safeguard to ensure the best interests of the
patients participating in this trial," commented Dr. Yatscoff. "The
DMC has reviewed the unblinded data and concur with the safety and
efficacy profiles. I look forward to releasing the unblinded 12 week
data this October. The final 24 week unblinded data set is expected
to be released in the first half of 2006."
The management team will provide an overview of the blinded
interim Phase III psoriasis data to the investment community this
morning commencing at 9:00 a.m. ET/7:00 a.m. MT. All Interested
parties can access the live web cast (listen only mode) by entering
http://www.newswire.ca/en/webcast/index.cgi?okey(equal sign)64134 in
their web browser. Alternatively, you may access the web cast through
our corporate Web site at www.isotechnika.com. The web cast will be
archived for a six month period through the web cast archives at
www.newswire.ca.
Edmonton-based Isotechnika Inc. is an international
biopharmaceutical company focused on the discovery and development of
novel immunosuppressive therapeutics that are safer than currently
available treatments. To find out more about Isotechnika Inc. (TSX:
ISA), please visit our Web site 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.

Contact:

Dr. Randall Yatscoff, President & COO, Isotechnika Inc., Tel:
+1-(780)-487-1600 Ext. 246, Fax: +1-(780)-484-4105, Email:
ryatscoff@isotechnika.com; Stephanie Gillis-Paulgaard, Senior
Manager, Corporate Communications, Isotechnika Inc., Phone:
+1-(780)-487-1600 Ext. 243,
Fax: +1-(780)-484-4105, E-mail:sgillis-paulgaard@isotechnika.com; To
request
a free copy of this organization's annual report, please go to
http://www.newswire.ca and click on reports@cnw

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