Health Canada Allows Isotechnika to Continue Patients on ISA247 Until Commercialization
Edmonton, Canada (ots/PRNewswire)
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Isotechnika today announced that the Company has received a No Objection Letter from Health Canada for the long term use of ISA247 in patients currently participating in the Canadian arm of the Company's Phase 2b kidney transplant trial.
The No Objection Letter allows patients to remain on ISA247 through to commercialization of the drug and beyond after completion of the 12 month Phase 2b trial. Patients choosing to remain on ISA247 therapy will continue to have safety and efficacy parameters monitored on an ongoing basis. A similar protocol amendment for the long term use of ISA247 has also been submitted to the Food and Drug Administration of the United States.
"We submitted the protocol amendment for the long term use of ISA247 after receiving numerous requests from investigators and patients currently involved in our kidney transplant trial," said Dr. Randall Yatscoff, Isotechnika's President & Chief Executive Officer. Dr. Yatscoff added, "Transplant patients are required to remain on immunosuppressive therapies for the rest of their lives. It is expected that the majority of our patients will choose to continue the use of ISA247. We are excited that our patients have the opportunity to continue on ISA247 which should make a real difference in the quality of their lives."
North American Phase 2b Kidney Transplant Trial Design
Forty-two centers across North America have been contracted to perform the trial, including thirty-eight centers in the United States and four centers in Canada. The primary endpoint of the trial is defined as non- inferiority in biopsy proven acute rejection (BPAR) episodes in patients receiving ISA247 for six months as compared to the tacrolimus control which is currently the North American leading transplant drug in this class. Additionally, kidney function and other laboratory parameters will be monitored for the duration of the trial. The overall goal of the trial is to find the most appropriate dose that will result in efficacy (lack of acute rejection) with minimal side effects that are typically seen with other calcineurin inhibitors such as cyclosporine and tacrolimus.
A total of 332 de novo (newly transplanted) kidney transplant patients will be enrolled in this trial. Patients will be placed into one of four separate treatment groups; three different dose groups of ISA247 (0.4 mg/kg, 0.6 mg/kg, and 0.8 mg/kg twice daily) compared with the fourth group, a tacrolimus (0.05 mg/kg twice daily) control arm. Patients in all four treatment groups will have their doses adjusted in order to achieve pre- defined blood levels of either ISA247 or tacrolimus. All patients will receive oral treatment of drug (ISA247 or tacrolimus) over a six month period along with other standard immunosuppressive therapies used following transplantation. Patients completing the six month trial will be given the option to continue therapy for an additional six months. The objective is to gather long term safety and efficacy data in de novo transplant patients.
About Isotechnika
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 (with Hoffman La Roche) and treatment of autoimmune disorders such as uveitis (with Lux Biosciences) and psoriasis.
There is a significant unmet medical need in the treatment of both solid organ transplantation and autoimmune disease. It is estimated that the market potential exceeds CDN$2 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 Phase 3 European/Canadian psoriasis trial and a Phase 2b North American trial for the prevention of kidney graft rejection subsequent to transplantation.
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 & 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: +1-780-909-4661, Fax: +1-780-484-4105, E-mail:
sgillis-paulgaard@isotechnika.com