Isotechnika Receives Approval From Polish Competent Authority for Pivotal Phase 3 Psoriasis Clinical Trial
Edmonton, Canada (ots/PRNewswire)
- Trades on Toronto Stock Exchange - (TSX:ISA)
Isotechnika Inc. announced today that the Company received approval from the Polish Competent Authority for participation in the ongoing Phase 3 European/Canadian clinical trial. This trial investigates the use of ISA247 in patients suffering from moderate to severe psoriasis. The Company previously received approval from the German Competent Authority and Health Canada to commence the trial. At present, a total of 283 patients have been enrolled in Germany and Canada.
"The addition of twelve clinical trial sites in Poland allows others to gain experience with ISA247 for the treatment of psoriasis and further broadens our investigator base. Addition of these sites, to the twenty-nine sites already established in Germany and Canada, should facilitate us meeting our expected recruitment timelines for this trial," stated Dr. Randall Yatscoff, Isotechnika's President & CEO. "Patient enrolment in Poland is expected to commence immediately."
Phase 3 European/Canadian Trial Design
The Phase 3 European/Canadian psoriasis trial (ESSENCE) will be performed at forty-one clinical centers in Canada, Germany, and Poland. The 24-week trial is being conducted as a randomized, orally administered placebo and cyclosporine controlled trial. To maximize the benefit to patients enrolled in the placebo group, all patients randomized to the placebo group will receive active treatment with ISA247 beginning after 12 weeks of placebo dosing.
To determine successful completion of the trial, the following efficacy parameters will be measured: Static Physician's Global Assessment (SPGA) scores, Psoriasis Area and Severity Index (PASI) scores. Safety parameters will also be monitored by measuring the prevalence of adverse events, including altered kidney function.
About Isotechnika Inc.
Edmonton-based Isotechnika Inc. is an international biopharmaceutical company focused on the discovery and development of novel immunosuppressive therapeutics that are designed to offer advantages over other currently available treatments while offering therapeutic choices to clinicians. Isotechnika looks to become the market leader of drug therapies for indications such as transplantation of solid organs and treatment of autoimmune disorders such as psoriasis.
There is a significant unmet medical need in both solid organ transplantation and autoimmune disease. It is estimated that the market potential far exceeds $1 billion annually in sales for calcineurin inhibitors such as ISA247.
Isotechnika's lead drug, ISA247, has successfully completed a Phase 3 Canadian trial for the treatment of moderate to severe psoriasis. ISA247 is currently being investigated in a combined Phase 3 European/Canadian psoriasis trial and a Phase 2b North American trial for the prevention of kidney graft rejection. One of our partners, Lux Biosciences, has received permission from the regulatory bodies in Austria, Canada, France, Germany, India, the United Kingdom and the United States to investigate ISA247 in three separate pivotal Phase 2/Phase 3 trials for the treatment of non- infectious uveitis and as a maintenance therapy in uveitis.
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. signed a collaboration agreement with Hoffman La Roche on April 9, 2002, 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 medical 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 all forms of 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.
www.isotechnika.com
Contact:
For further information: Dr. Randall Yatscoff, President & CEO,
Isotechnika Inc., Phone: +1-780-487-1600 Ext. 247, 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