Isotechnika Achieves Target Enrolment for Phase III Psoriasis Trial
Edmonton, Canada (ots/PRNewswire)
Isotechnika Inc. announced today that the original target of 400 subjects for its Canadian Phase III psoriasis trial for its lead immunosuppressive compound, ISA247 has been reached. Due to the enthusiasm of our investigators and the willingness of patients to participate in the trial, the Company will allow approximately 80 additional patients to receive drug treatment. Total enrolment for the trial will therefore be approximately 480 patients.
The trial, which commenced on December 2, 2004, is currently being conducted at thirty-two centres across Canada and involves patients with moderate to severe psoriasis. Patients have been randomised to one of the four dosing arms; high dose (0.4 mg/kg twice daily), mid dose (0.3 mg/kg twice daily), low dose (0.2 mg/kg twice daily) and placebo. Subsequent to the first 12 weeks, those patients who received placebo will be administered the mid dose range dose of 0.3 mg/kg twice daily for the remaining 12 weeks of the study.
"Our willingness to allow additional subjects into the trial was based on numerous requests received from our investigators and those patients suffering from psoriasis," stated Dr. Randall Yatscoff, Isotechnika's President and Chief Operating Officer. "Requests to allow for additional psoriasis patients to be added to the trial likely speak to the unmet medical need of trying to find safer and efficacious drug therapies. The Company anticipates release of interim results, which is based on 300 patients completing the first twelve weeks of treatment, to the investment and scientific community in the third quarter of 2005 with final results expected in early 2006."
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 drug, ISA247, presently referred to as trans-ISA247, is an immunosuppressant that has successfully completed a Phase II trial for psoriasis and Phase IIa trial for kidney transplantation. The Company also has two additional immunosuppressive compounds in its drug pipeline, TAFA93 and TKB662. Both compounds are in early stage clinical development, Phase I and pre-clinical respectively.
In addition to the Company's drug pipeline, Isotechnika also has a diagnostic division, which includes the Helikit(TM) and Diatest(TM) breath kits. The Helikit(TM), a (13)C breath test is used for the detection of H.pylori, a bacterium that infects a large portion of the population. The Diatest(TM), a (13)C 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.
Forward-Looking Statements
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.
Contact:
Dr. Randall Yatscoff, President & COO, Isotechnika Inc., Phone:
+1-780-487-1600 Ext.246, Fax: +1-780-484-4105, Email:
ryatscoff@isotechnika.com; Stephanie Gillis-Paulgaard, Senior
Manager, Corporate Communications & Investor Relations, Isotechnika
Inc., Phone: +1-780-487-1600 Ext. 243, Fax: +1-780-484-4105, E-mail:
sgillis-paulgaard@isotechnika.com