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Isotechnika Announces Preliminary Phase III Psoriasis Results
Edmonton, Canada (ots/PRNewswire) - Isotechnika Inc. announced today that the Canadian Phase III psoriasis trial for its lead immunosuppressive drug, ISA247, continues to show promising results.
The Canadian Phase III Psoriasis trial (SPIRIT) which commenced on December 2, 2004, includes a total of 453 patients with stable moderate to severe plaque psoriasis. The trial is currently being conducted in 32 sites and is the largest of its kind in Canada using an orally administered systemic medication in psoriasis. This randomised, 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) over a 24 week period compared to placebo. Equal numbers of patients are assigned to each of the four treatment groups. The primary endpoint being investigated is the number of patients achieving a 75% decrease in the Psoriasis Area and Severity Index (PASI) score at 12 weeks. Subsequent to the first 12 weeks, those patients who received placebo will be administered the mid-dose of 0.3 mg/kg twice daily for the remaining 12 weeks of the study. Patients already receiving active treatment with ISA247 will remain in their respective dosing groups for the final 12 weeks until completion of the trial.
Following the 24 week duration of this phase III trial, patients will be given the opportunity to continue therapy for an additional 36 weeks through an extension study. The extension protocol was designed to meet the numerous requests from trial investigators currently involved in the Phase III trial. Patients choosing to continue treatment will receive twice daily administration of oral ISA247 capsules at 0.3 mg/kg, the mid-dose of the SPIRIT trial. The primary reason for the extension study is to gather longer term safety data to facilitate the advancement of ISA247 through the clinical trial process.
Based on blinded data from 200 patients treated with either ISA247 or placebo for at least 12 weeks, PASI scores were, on average, reduced and were comparable to those observed in our previous successful Phase II trial. A clinical response in our current trial, as determined by PASI scores, has been shown in patients as early as 4 weeks after starting therapy. Dr. Darryl Toth, a principal investigator in the trial from Probity Medical Research states, "In patients at my site, I have observed a trend towards a reduction in PASI scores correlating with a decrease in patient's symptoms which is indicative of good efficacy. Based on my clinical observations to date, the data suggests that ISA247 is an efficacious treatment with a promising safety profile."
"ISA247 belongs to a class of drugs known as 'calcineurin inhibitors' and it is well known that other drugs within this class may have significant negative effects on kidney function," states Dr. Randall Yatscoff, Isotechnika's President & COO. "In addition to monitoring overall patient safety, we are carefully monitoring kidney function in this trial with ISA247. In particular, we are measuring serum creatinine and determining glomerular filtration rate (GFR), a more accurate measure of kidney function, in all patients. The blinded data for all patients completing the first 12 weeks of treatment indicates that kidney function remains stable. Other laboratory parameters measured including, for example, cholesterol, triglycerides, and white blood cell count also remained stable throughout the trial. The current blinded data generated from the first half of our phase III trial of ISA247 is encouraging. We continue to look forward to meeting our drug development timelines for this important indication."
The management team will provide an overview of the blinded Phase III psoriasis data to the investment community this morning commencing at 9:00 a.m. EDT/7:00 a.m. MDT. All Interested parties can access the live web cast (listen only mode) by entering http://w.on24.com/r.htm?e=12677&s=1&k=5CCE06914B951157D9FE4209C8A56EFD 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 90 day 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 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.
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 commercialise 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.
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Isotechnika Inc., Phone: +1-780-487-1600 Ext. 246, Fax:
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