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Isotechnika Announces Nine Month Safety Data From the Phase III Psoriasis Trial for ISA247
Edmonton, Canada (ots/PRNewswire) - Isotechnika Inc. (TSX:ISA) announced today nine month interim safety and efficacy data obtained from its 24 week Phase III psoriasis trial and 12 week extension 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. Ninety percent of patients who completed the trial chose to enroll in the extension trial. Those patients who chose to enroll in the extension trial were moved from the 0.2 mg/kg (low dose) or 0.4 mg/kg (high dose) bid 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 goals of the extension trial are to demonstrate continued therapeutic benefit to psoriasis patients and to gather longer term safety and efficacy data.
To date, 254 patients have completed 12 weeks of the extension trial for a total 36 weeks of treatment. The data indicates that there are no clinically or statistically significant changes in serum creatinine or glomerular filtration rate (GFR) over the duration of the trial period.
As anticipated, the improvement in PASI scores remained fairly stable for those patients previously in the mid dose group of the SPIRIT trial. Patients previously in the low dose group have seen an improvement in mean percent change in PASI scores from 42% to 66% after 12 weeks on the mid dose. Patients previously in the high dose group have seen a slight change in PASI scores from 70% to 61%.
"Our optimism regarding the efficacy of ISA247 and lack of renal or any other toxicity seen after 24 weeks of therapy is confirmed in the extension study data to date," stated Dr. Gilles Lauzon, Director of the Division of Dermatology at the University of Alberta.
"I am extremely pleased that the nine month data strongly suggests long term safety of ISA247 in patients suffering from moderate to severe psoriasis," added Dr. Randall Yatscoff, Isotechnika's President & CEO. "The data generated to date continues to support the safety and efficacy profile of ISA247. In addition, the Company reached a significant milestone with ISA247 treatment. Beginning on December 2, 2005, a number of psoriasis patients have received continuous oral treatment of ISA247 for one year. We look forward to receiving data on these patients in the coming months."
Management will host a conference call to provide an overview of the nine month interim safety data this afternoon at 4:15 p.m. EST / 2:15 p.m. MST. All Interested parties can access the live conference call (listen only mode) by accessing http://www.newswire.ca/en/webcast/viewEvent.cgi?eventID=1326820 or through the home page of the Company's corporate Web site at www.isotechnika.com. The conference call will be archived for 90 days through the web cast archives at www.newswire.ca.
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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