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Isotechnika Announces Preliminary 48 Week Clinical Data From the Phase III ISA247 Psoriasis Trial
Edmonton, Canada (ots/PRNewswire) - Isotechnika Inc. (TSX:ISA) announced today preliminary 48 week clinical data obtained from its Phase III psoriasis and extension trials for its lead immunosuppressive drug, ISA247.
Patients completing the 24 week Canadian Phase III SPIRIT trial were given the opportunity to continue therapy for an additional 36 weeks or to discontinue therapy. Those patients who chose to enroll in the extension trial were moved from the 0.2 mg/kg bid (low dose) or 0.4 mg/kg bid (high dose) groups into the 0.3 mg/kg bid (mid dose) group. Patients who commenced the SPIRIT trial in the 0.3 mg/kg bid dose group remained on the same dosage regimen for the duration of the extension trial. The goal of the extension trial is to demonstrate continued therapeutic benefit to psoriasis patients while gathering long term safety data.
To date, data has been received on 193 patients receiving treatment for a total of 48 weeks. Patients previously in the low dose group experienced an improvement in mean percent decrease in PASI scores from baseline of 41% to 64% after an additional 24 weeks on the mid dose. Patients previously in the mid and high dose group remained stable with mean percent decrease from baseline PASI scores of 61% and 66%, respectively after a total of 48 weeks of treatment.
Of the total patient population, 4.4% (9 patients in the SPIRIT trial and 11 patients in the extension trial), showed a clinically significant change in kidney function. There have been no clinically significant changes noted during the extension trial in any of the other safety parameters monitored including cholesterol, triglycerides, new onset diabetes and infectious complications.
"It is essential that new psoriasis medications are developed and heartening to see that such an efficacious medication with an excellent 48 week safety profile is in the pipeline," commented Dr. Robert Auerbach, Clinical Professor of Dermatology, New York University School of Medicine.
"We are pleased that the extension data shows continued efficacy and safety of ISA247. The number of patients experiencing a clinically significant reduction in kidney function is significantly less than with other calcineurin inhibitors such as cyclosporine where the incidence is at least 20%," added Dr. Randall Yatscoff, Isotechnika's President & CEO. "In addition, the absence of any clinically significant changes in lipids, glucose and blood pressure levels, along with the absence of significant infectious complications, supports the long term safety of ISA247 administration."
Management will host a web cast to provide an overview of the preliminary 48 week clinical data this morning at 9:00 a.m. EST/ 7:00 a.m. MST. All Interested parties can access the live web cast (listen only mode) by accessing http://www.newswire.ca/en/webcast/index.cgi?okey=64134 or through the home page of the Company's corporate Web site at www.isotechnika.com. The web cast will be archived for 90 days at www.newswire.ca and the Company's Web site.
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) breath kit. 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.
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.
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