EDMONTON, Nov. 16 /PRNewswire-FirstCall/ - Isotechnika Inc. today announced results from initial data for its Phase IIb kidney transplant trial of the Company’s lead immunosuppressive drug, ISA247.
To date, 133 patients have been enrolled in the trial. Based on an early review of the unaudited data, the Company has observed a similar incidence of rejection episodes between the low (0.4 mg/kg twice daily) and mid (0.6 mg/kg twice daily) ISA247 dosing groups as in the tacrolimus control arm. To date, there have been no rejections in the high (0.8 mg/kg twice daily) ISA247 dose group. When all three of the ISA247 dosing groups are combined, there is an 8% rate of acute rejection in the ISA247 groups compared to a 14% rate in the tacrolimus group, which is being dosed according to clinical practice.
As part of the trial, kidney function is being measured by Glomerular Filtration Rate (GFR) on an ongoing basis. Based on the data generated to date, very good kidney function has been observed in all of the ISA247 dosing groups. Within the first month post-transplant, kidney function showed improvement across all ISA247 dosing groups similar to that observed in the tacrolimus group. Additionally, there have been no clinically significant differences noted in cholesterol and triglycerides or other laboratory parameters examined to date in patients receiving ISA247.
“We are pleased that all three ISA247 doses are showing good efficacy while maintaining very good kidney function,” stated Dr. Randall Yatscoff, President & CEO of Isotechnika. “Furthermore, ISA247 continues to demonstrate a strong Pharmacokinetics and Pharmacodynamics (PK/PD) correlation which should facilitate ease of dosing to achieve desired targeted drug concentrations in blood.”
The Phase IIb kidney transplant data is being presented today at the American Society of Nephrology Conference in San Diego. The poster entitled “ISA247: A Novel Calcineurin Inhibitor (CNI) A Promising Safety Profile With Enhanced Efficacy” will be presented by Dr. Robert Gaston, one of the principal investigators involved in the Phase IIb trial. All interested parties will be able to access a copy of the scientific poster in the Investor Relations section of the web site.
The management team will provide an update on the current status of the Phase IIb kidney transplant trial via a live web cast this morning at 9:00 a.m. ET/7:00 a.m. MT. All interested parties will be able to access the live event through the Company’s corporate web site at www.isotechnika.com.
Trial Design
Forty-two centers across North America have been contracted to perform the trial, including thirty-seven centers in the United States and five 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.
About Isotechnika -----------------
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 successfully completed a Canadian Phase III human clinical trial for the treatment of moderate to severe psoriasis. ISA247 is currently being investigated in 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 ------------
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
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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.
Isotechnika Inc.
CONTACT: Dr. Randall Yatscoff, President & CEO, Isotechnika Inc., Phone:(780) 487-1600 Ext. 246, Fax: (780) 484-4105, Email:ryatscoff@isotechnika.com; Stephanie Gillis-Paulgaard, Director, CorporateCommunications, Isotechnika Inc., Phone: (780) 909-4661, Fax: (780)484-4105, E-mail:sgillis-paulgaard@isotechnika.com
