Isotechnika Receives Approval From the German Competent Authority for a Pivotal Phase III Psoriasis Clinical Trial
Edmonton, Canada (ots/PRNewswire)
Isotechnika Inc. announced today that the Company received approval from the German Competent Authority to conduct a pivotal Phase III clinical trial for the treatment of moderate to severe psoriasis with its lead immunosuppressive drug, ISA247.
The Phase III European/Canadian psoriasis trial (ESSENCE trial) will be performed over a 24 week period at a total of thirty-six centers in Germany, Poland and Canada involving a total of 500 patients with moderate to severe psoriasis. The trial will be conducted as a randomized, orally administered placebo and cyclosporine controlled study with 300 patients receiving ISA247 (0.4 mg/kg twice daily), 100 patients receiving cyclosporine (1.5 mg/kg twice daily), and 100 patients receiving placebo. In an effort to maximize the benefit to patients enrolled in the placebo group ISA247 will be administered at a dose of 0.4 mg/kg twice daily following the first 12 weeks.
Successful completion of the trial will be determined by the following endpoints;
Primary endpoint
- superiority in the proportion of subjects achieving a score of
"clear" or "almost clear" in the Static Physician's Global Assessment
(SPGA) score at 12 weeks in the ISA247 treatment group compared to
placebo control.
Secondary endpoints
- non-inferiority of ISA247 compared to cyclosporine control in the
proportion of subjects achieving a score of "clear" or "almost clear"
in the Static Physician's Global Assessment (SPGA) score at 12 weeks;
- a 75% reduction in the Psoriasis Area and Severity Index (PASI) score
at 12 weeks of ISA247 versus placebo; and
- maintenance of stable kidney function."Moving our late-stage clinical development plan for ISA247 forward in psoriasis and kidney transplantation continues to be our primary focus," stated Dr. Randall Yatscoff, Isotechnika's President & CEO. "Following our first phase III psoriasis trial approval and subsequent completion in Canada, this second phase III approval for moderate to severe psoriasis now allows us the opportunity to expand our trials into Europe. In anticipation of this approval, clinical trial sites have been selected. Patient enrollment will commence later this year."
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 compound, ISA247 has completed an extension protocol of a Canadian Phase III human clinical trial for the treatment of moderate to severe psoriasis and a North American Phase IIb human clinical trial for the prevention of kidney graft rejection. The Company also has an additional immunosuppressive compound in its drug pipeline, TAFA93 which successfully completed Phase I clinical trials.
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.
Partnerships with Isotechnika Inc.
Isotechnika Inc. has a collaboration agreement with Hoffman La Roche which licensed the worldwide rights to develop and commercialize ISA247 for all transplant indications.
On September 30, 2005, Isotechnika Inc. entered into 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.
Isotechnika Inc. and Cellgate Inc. signed an option agreement on April 25, 2006, granting Isotechnika the option to obtain an exclusive license to develop and commercialize conjugates consisting of Cellgate's patented transporter technology for the topical delivery of ISA247 in patients suffering from mild to moderate psoriasis.
On May 25, 2006, Isotechnika Inc. signed an agreement with Lux Biosciences, Inc. of Jersey City, New Jersey granting Lux Biosciences worldwide rights to develop and commercialize Isotechnika's lead drug, ISA247 for the treatment and prophylaxis of all ophthalmic diseases.
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 & CEO,
Isotechnika Inc., Phone: +1-(780)-487-1600 Ext. 246, Fax:
+1-(780)-484-4105, Email: ryatscoff@isotechnika.com; Stephanie
Gillis-Paulgaard, Director, Corporate Communications, Isotechnika
Inc., Phone: +1-(780)-487-1600 Ext. 243, Fax: +1-(780)-484-4105,
E-mail:sgillis-paulgaard@isotechnika.com