FDA Allows Long Term Use of ISA247 in Isotechnika Phase 2b Kidney Transplant Trial
Edmonton, Canada (ots/PRNewswire)
Isotechnika today announced that the Company has received permission from the Food and Drug Administration of the United States (FDA) for the long term use of ISA247 in patients currently participating in the Company's Phase 2b kidney transplant (PROMISE) trial. The Company previously announced in June that it had also received a No Objection Letter from Health Canada for the long term use of ISA247 in this trial.
Patients involved in the PROMISE trial are allowed to remain on ISA247 through to commercialization of the drug and beyond after completion of the 12 month trial. Patients choosing to remain on ISA247 therapy will continue to have safety and efficacy parameters monitored on an ongoing basis.
"With this approval from the FDA along with the previously received approval from Health Canada all patients enrolled in the PROMISE trial will have the opportunity to continue on ISA247 for the long term," stated Dr. Randall Yatscoff, Isotechnika's President & CEO. "It is our belief that by having patients continue to receive ISA247 therapy we are contributing to an improved quality of life subsequent to transplantation. The long term data received from these patients will facilitate ISA247 achieving its commercial potential."
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 leading North American 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. The use of the other two calcineurin inhibitors, cyclosporin and tacrolimus, are often associated with significant safety concerns.
A total of 332 de novo (newly transplanted) kidney transplant patients have been 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 control arm (0.05 mg/kg twice daily). 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 dosing with the drug (ISA247 or tacrolimus) over a six month period along with other standard immunosuppressive therapies used following transplantation.
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 US$ 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 http://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 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: +1-780-487-1600-247, Fax: +1-780-484-4105,
ryatscoff@isotechnika.com; Stephanie Gillis-Paulgaard, Director,
Corporate Communications, Isotechnika Inc., Phone: +1-780-909-4661,
Fax: +1-780-484-4105, sgillis-paulgaard@isotechnika.com