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Isotechnika Announces Ninety Per Cent Participation in Phase III Psoriasis Extension Trial
Edmonton, Canada (ots/PRNewswire) - Isotechnika Inc. (TSX: ISA) announced today the participation level in its Canadian Phase III psoriasis extension trial 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. Of the patients who completed the 24 week trial 90% chose to continue treatment. The patients who enrolled in the open label extension trial are receiving administration of oral ISA247 capsules at 0.3 mg/kg twice daily, which was the mid-dose used in the SPIRIT trial. The goals of the extension trial are to provide continued therapeutic benefit to psoriasis patients and to gather longer term safety and efficacy data. This data should facilitate the advancement of ISA247 through the clinical trial process.
"As a clinical investigator with 20 years experience, the 90% enrollment in the current Isotechnika Phase III extension trial for psoriasis speaks volumes. It indicates patients are extremely satisfied and pleased with not only the efficacy, but the safety of this drug. Typically, extension studies do not normally attain such high enrollment figures," commented Dr. Charles Lynde, a principal investigator involved in the Phase III psoriasis trial.
"The overwhelming participation in this extension trial attests to the high degree of acceptance of ISA247 by both the patients and the physicians," stated Dr. Randall Yatscoff, Isotechnika's President & COO. "We are confident that the unblinded 12 week data from the SPIRIT trial will continue to demonstrate a promising safety and efficacy profile for ISA247. The 12 week unblinded results are expected to be announced in the next few weeks."
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 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.
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