Isotechnika's Phase III Psoriasis Trial Achieves Clinical Endpoints
Edmonton, Canada (ots/PRNewswire)
Isotechnika Inc. announced today the unblinded 12 week data for the Company's Canadian Phase III psoriasis trial for its lead immunosuppressive drug, ISA247.
A Summary of the results is as follows:
- The study met all primary and secondary efficacy endpoints determined
at 12 weeks
- Efficacy endpoints were achieved with minimal side effects
- No clinically significant differences in mean serum creatinine and
glomerular filtration rate (GFR) were observed amongst the four
treatment groups at 12 weeksThe Canadian Phase III Psoriasis (SPIRIT) trial commenced on December 2, 2004 and included a total of 453 patients with stable moderate to severe plaque psoriasis. The trial was conducted at 32 sites over a 24 week period using orally administered ISA247 in psoriatic patients. This randomized, double-blind trial examined the efficacy of three dosing groups of ISA247 (0.2 mg/kg, 0.3 mg/kg and 0.4 mg/kg) administered twice daily compared to placebo with equal numbers of patients assigned to each of the four treatment groups.
"Our goal was to create a drug with a superior safety and efficacy profile compared to other medications used to treat psoriasis," stated Dr. Randall Yatscoff, Isotechnika's President and COO. "We are pleased to have achieved these goals in the interim data analysis which indicates the presence of a therapeutic window. It is very encouraging to see that our 24 week endpoints were achieved at the 12 week point of the trial."
In the high dose group, 48% of the patients achieved a PASI 75 score and 72% achieved a PASI 50 score. Furthermore, in the mid dose group 24% and 47% of the patients achieved PASI 75 and PASI 50 scores, respectively. Both the PASI 50 and PASI 75 scores were clinically significant (p less than 0.05) versus placebo. The mean percentage reduction in the PASI scores of the high dose group and the mid dose group were 62.5% and 44.0%, respectively.
Incidences of treatment-related adverse events in patients receiving ISA247 were similar to those receiving placebo. Additionally, there were no clinically significant changes noted in any of the parameters monitored including hypertension, cholesterol, triglycerides and infectious complications analyzed for the interim report. The highest mean change in serum creatinine at 12 weeks was 5% above baseline in the high dose (0.4 mg/kg twice daily) group. This mean percentage change is not clinically significant as it is within normal analytical and physiological variation. After 12 weeks of treatment, a total of five patients, (four in the high dose (4%) and one in the mid dose (1%)) were withdrawn from the trial due to a clinically significant effect on kidney function.
"The results with ISA247 indicate that efficacy equals that of the best treatments presently available for severe psoriasis. This study positions ISA247 as a possible first line therapy for severe psoriasis while providing a side-effect profile not different from placebo," states Dr. Gilles Lauzon, Director of the Division of Dermatology at the University of Alberta.
The management team will provide an overview of the unblinded 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.
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 is an immunosuppressant currently in a Canadian Phase III human clinical trial for the treatment of moderate to severe psoriasis. In addition, ISA247 has successfully completed a Phase IIa trial for kidney transplantation. The Company also has two additional immunosuppressive compounds in its drug pipeline, TAFA93 and TKB662 which are in Phase I and pre-clinical respectively.
In addition to the Company's drug pipeline, Isotechnika also has a diagnostic division, which includes the Helikit(R) and Diatest(R) breath kits. The Helikit(R) a (13)C urea breath test is used for the detection of H. pylori, a bacterium that infects a large portion of the population. The Diatest(R) a (13)C glucose breath test is used to measure insulin resistance.
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.
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.
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Contact:
For further information: Dr. Randall Yatscoff, President & COO,
Isotechnika Inc., Phone: +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; Archived
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