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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 After 12 weeks of treatment, a total of five patients which represents less than 2% of the 369 patients were withdrawn from the trial due to a clinically significant effect on kidney function.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.
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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