Magazin

2005-08-03

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 itslead immunosuppressive drug, ISA247, continues to demonstrate apromising safety and efficacy profile.

The Canadian Phase III Psoriasis (SPIRIT) trial commenced onDecember 2, 2004 and includes a total of 453 patients with stablemoderate to severe plaque psoriasis. The trial is currently beingconducted at 32 sites over a 24 week period and is the largest of itskind in Canada using an orally administered systemic medication inpsoriasis. This randomized, double-blind, trial examines the efficacyof 3 dosing groups of ISA247 (0.2 mg/kg, 0.3 mg/kg and 0.4 mg/kgtwice daily) compared to placebo with equal numbers of patientsassigned to each of the four treatment groups. Subsequent to thefirst 12 weeks, those patients who received placebo were administeredthe mid-dose of 0.3 mg/kg twice daily for the remaining 12 weeks ofthe study. Patients already receiving active treatment (ISA247)remained in their respective dosing groups for the final 12 weeks ofthe trial.

Based on blinded data from 369 patients treated with either ISA247or placebo for at least 12 weeks, the mean decrease in Psoriasis Areaand Severity Index (PASI) scores for all four treatment groupscombined (including the placebo group) was 38%. The blinded data hasalso indicated a good safety profile. The highest mean change inserum creatinine at 12 weeks in any of the dosing groups was 5.6%above baseline which is within normal analytical and physiologicalvariation. After 12 weeks of treatment, a total of five patientswhich represents less than 2% of the 369 patients were withdrawn fromthe trial due to a clinically significant effect on kidney function.

"I am extremely pleased with the safety and efficacy results ofthe blinded data. These results are in line with what we expectedbased on the results of our previous successful Phase II trial,"stated Dr. Randall Yatscoff, Isotechnika's President and COO. "Basedon the blinded data to date we are confident we will show aclinically and statistically significant difference in the number ofpatients achieving a 75% decrease in the PASI score at 12 weeks whencompared 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 trialand past president of the Canadian Dermatology Association stated,"The study is blinded; however, clinically there is a sub group thathas done extremely well with marked PASI reductions, many becomingcompletely clear after 8-12 weeks of therapy. Overall side effectsare at a minimum with little blood pressure elevation or creatinineclearance disturbance seen. This is in contradiction to cyclosporinewhere blood pressure elevations and creatinine clearance are often aproblem."

"Earlier this year an independent data monitoring committee (DMC)was formed as a special safeguard to ensure the best interests of thepatients participating in this trial," commented Dr. Yatscoff. "TheDMC has reviewed the unblinded data and concur with the safety andefficacy profiles. I look forward to releasing the unblinded 12 weekdata this October. The final 24 week unblinded data set is expectedto be released in the first half of 2006."

The management team will provide an overview of the blindedinterim Phase III psoriasis data to the investment community thismorning commencing at 9:00 a.m. ET/7:00 a.m. MT. All Interestedparties can access the live web cast (listen only mode) by enteringhttp://www.newswire.ca/en/webcast/index.cgi?okey(equal sign)64134 intheir web browser. Alternatively, you may access the web cast throughour corporate Web site at www.isotechnika.com. The web cast will bearchived for a six month period through the web cast archives atwww.newswire.ca.

Edmonton-based Isotechnika Inc. is an internationalbiopharmaceutical company focused on the discovery and development ofnovel immunosuppressive therapeutics that are safer than currentlyavailable 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 thepotential of its products, the Company's expectations regarding theissuance of additional patents and the Company's ability to protectits intellectual property, involve known and unknown risks anduncertainties, which could cause the Company's actual results todiffer materially from those in the forward-looking statements. Suchrisks and uncertainties include, among others, the availability offunds and resources to pursue research and development projects, theability to economically manufacture its products, the potential ofits products, the success and timely completion of clinical studiesand trials, the Company's ability to successfully commercialize itsproducts, the ability of the Company to defend its patents frominfringement by third parties, and the risk that the Company'spatents may be subsequently shown to be invalid or infringe thepatents of others. Investors should consult the Company's quarterlyand annual filings with the Canadian commissions for additionalinformation on risks and uncertainties relating to theforward-looking statements. Investors are cautioned against placingundue reliance on forward-looking statements.

ots Originaltext: Isotechnika Inc.Im Internet recherchierbar: http://www.presseportal.de

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 requesta free copy of this organization's annual report, please go to http://www.newswire.ca and click on reports@cnw

Isotechnika Inc.

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