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Isotechnika's Phase III Psoriasis Spirit Trial Achieves Safety and Efficacy Endpoints
Edmonton, Canada, November 7 (ots/PRNewswire) - Isotechnika Inc. (TSX: ISA) announced today the unaudited 24 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:
- All primary and secondary efficacy endpoints were achieved at 24 weeks
- Efficacy endpoints were achieved with minimal side effects
- In the mid- and low-dose groups, continued improvement in PASI scores were observed from 12 to 24 weeks
- No clinically significant differences in mean serum creatinine and glomerular filtration rate (GFR) were observed amongst the four treatment groups at 24 weeks
"We are extremely pleased to have met our endpoints and achieved a dose that demonstrates a continual increase in efficacy with minimal effect on renal function," stated Dr. Randall Yatscoff, Isotechnika's President & CEO. "Again, this positions us well for future clinical trials with ISA247. This data supports that ISA247, at therapeutic doses, is efficacious with minimal side effects."
The overall decrease in PASI scores at 24 weeks for the low (0.2 mg/kg twice daily), mid (0.3 mg/kg twice daily) and high (0.4 mg/kg twice daily) dose groups were 41%, 55% and 70%, respectively. For the placebo patients that converted to the mid dose group at 12 weeks the overall decrease in PASI score was 62%. The PASI 50 scores at 24 weeks for the mid (0.3 mg/kg twice daily) and high (0.4 mg/kg twice daily) dose groups were 56% and 70%, respectively. PASI 75 scores for the mid and high dose groups were 26% and 49% at 24 weeks. Patients treated in the mid dose group and low dose group (0.2 mg/kg twice daily) experienced a continual increase in efficacy over the 24 week period with minimal effect on renal function. Both the PASI 50 and PASI 75 scores were statistically significant (p less than 0.05) versus placebo. In all dose groups, PASI scores exhibited good efficacy.
Following 24 weeks of treatment, there were no clinically significant changes noted in the following parameters; hypertension, cholesterol, triglycerides and infectious complications which is consistent with the previously released interim report. Additionally, the incidence of treatment-related adverse events in patients receiving ISA247 was not different to those receiving placebo.
The mean decrease in glomerular filtration rate at 24 weeks in the low, mid and high dose groups was 3.0%, 2.8%, and 6.0%, respectively. This mean percentage change is not clinically significant as it is within normal analytical and physiological variation. There were no progressive changes in renal function from 12 to 24 weeks in all dose groups. Of the 451 patients enrolled in the trial a total of 7 patients, (six in the high dose (7%) and one in the mid dose (1%)) experienced two consecutive greater than 30% decreases in glomerular filtration rate. Patients originally receiving placebo that were subsequently crossed over to the mid-dose group at 12 weeks showed no change in kidney function.
Dr. Robert Bissonnette, a principal investigator involved in the Phase III SPIRIT trial stated, "Results from patients treated with ISA247 for 24 weeks confirm its safety and efficacy profile in the treatment of psoriasis. These results suggest that ISA247 could become one of our first line systemic treatments for moderate to severe psoriasis."
Management will provide an overview of the unblinded Phase III data this morning at 8:00 a.m. EST/6:00 a.m. MST. All Interested parties can access the live web cast (listen only mode) by going to http://www.newswire.ca/en/webcast/index.cgi?companyID=815958378. 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.
The Canadian Phase III Psoriasis (SPIRIT) trial commenced on December 2, 2004. 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. The 24 week results outlined below are based on a total of 451 patients.
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 an extension protocol of 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 an additional immunosuppressive compound in its drug pipeline, TAFA93 which is in Phase I.
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 13C 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 13C 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.
Isotechnika Inc. has a collaboration agreement with Hoffman La Roche which licensed the worldwide rights to develop and commercialize Isotechnika's novel molecule ISA247 for all transplant indications. In addition, the Company has 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.
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
Dr. Randall Yatscoff, President & CEO, Isotechnika Inc., Tel:
+1-780-487-1600 Ext. 246, Fax: +1-780-484-4105, Email:
firstname.lastname@example.org; Stephanie Gillis-Paulgaard, Director,
Corporate Communications, Isotechnika Inc., Tel: +1-780-487-1600 Ext.
243, Fax: +1-780-484-4105, E-mail: email@example.com;
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