Isotechnika Inc. receives No Objection Letter from Health Canada for Phase III Psoriasis Trial
Edmonton, Alberta (ots/PRNewswire)
Isotechnika Inc. announced today that the Company received a No Objection Letter from Health Canada for the commencement of a Phase III trial for its lead immunosuppressive drug candidate, ISA247.
The trial will be performed over a twenty-four week period at thirty- three centers across Canada involving a total of 400 subjects with severe psoriasis. It will be conducted as a randomized, double-blind study with 100 subjects receiving the high dose (0.4 mg/kg twice daily), 100 subjects receiving the anticipated therapeutic dose (0.3 mg/kg twice daily), 100 subjects receiving the low dose (0.2 mg/kg twice daily) and 100 subjects receiving placebo. In an effort to maximize the benefit to those enrolled in the study who may receive placebo for the first 12 week period they will be administered a dose of 0.3 mg/kg twice daily commencing the 13th week of the study. All doses of drug will be administered as soft gelatine capsules administered orally.
Successful completion of the trial will be determined by the proportion of subjects who achieve a 75% reduction in the psoriasis area and severity index (PASI). Secondary endpoints of the trial include maintenance of stable kidney function and assessment of quality of life. Blood specimens will also be collected periodically to gather additional pharmacokinetic and pharmacodynamic (PK/PD) data.
"Moving ISA247 into Phase III has been the Company's primary focus over the last year," stated Dr. Randall Yatscoff, Isotechnika's President and & COO. "Receipt of the No Objection Letter allows us to meet the drug development timelines set for ISA247 and establish Isotechnika as a Phase III company. Manufacturing of the drug supply was completed in an efficient and cost-effective manner."
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 use in the prevention of organ rejection in transplantation and in the treatment of autoimmune diseases. 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. Isotechnika recently expanded its product pipeline by developing two additional novel immunosuppressive compounds, TAFA93 and TKB662. TAFA93 is a novel small molecule mTOR inhibitor, a class of drugs currently used in the prevention of organ rejection in transplantation and as a coated stent therapy in the treatment of coronary artery disease. Pre-clinical studies of TKB662 have demonstrated inhibition of T cell and B cell activation and proliferation through multiple mechanisms of action including the inhibition of lymphocyte phosphorylation activity. As both TAFA93 and TKB662 have distinct mechanisms of action from calcineurin inhibitors such as ISA247 they have the potential to be administered as complementary therapies in both prevention of organ rejection and treatment of autoimmune diseases.
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 Helikit(TM) is currently sold internationally. The Diatest(TM), a (13)C glucose breath test is used for the detection of insulin resistance. The Company expects to commence the necessary clinical trials in 2005 involving the Diatest(TM) to obtain regulatory approval in the United States.
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 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.
Contact:
For further information: 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, Manager, Corporate Communications, Isotechnika
Inc., Phone: +1(780)-487-1600 Ext. 243, Fax: +1-(780)-484-4105,
E-mail:sgillis-paulgaard@isotechnika.com