FDA Permits Phase IIb Kidney Transplant Trial
May 13, 2005, 17:45, Reviewed by: Dr.
|"We are extremely pleased to receive permission from the FDA to conduct this Phase IIb trial as it validates the bridging studies performed by the Company last year. As a result of changing the manufacturing to the trans-ISA247, it was necessary to complete a number of bridging studies prior to filing for regulatory approval to commence the Phase IIb trial."
Isotechnika Inc. announced today that the Company has received permission from the Food and Drug Administration of the United States to proceed with a Phase IIb kidney transplant trial for its lead immunosuppressive drug, ISA247.
The planned randomized, open-label trial will include approximately 332 de novo (newly transplanted) kidney patients from clinical trial sites across North America. The Company previously received a No Objection Letter from Health Canada on April 28, 2005 to begin the Phase IIb kidney transplant trial.
Patients will be placed into one of four separate dosing groups. The four dosing groups will be comprised of three different targeted blood concentrations of ISA247 compared with the fourth group, a tacrolimus control arm. All patients will receive twice daily oral treatment of drug over a 24-week period. Treatment will commence at the time of transplant surgery.
The primary endpoint of the trial is defined as non-inferiority in biopsy proven acute rejection (BPAR) episodes with patients receiving ISA247 for six months as compared to tacrolimus. Additionally, patient's kidney function and other laboratory parameters such as hypertension, hyperlipidemia and new onset diabetes mellitus will be monitored for the duration of the trial.
"We are extremely pleased to receive permission from the FDA to conduct this Phase IIb trial as it validates the bridging studies performed by the Company last year. As a result of changing the manufacturing to the trans-ISA247, it was necessary to complete a number of bridging studies prior to filing for regulatory approval to commence the Phase IIb trial," stated Dr. Randall Yatscoff, Isotechnika's President & COO. "Our goal, subject to available financial resources, is to commence North American site selection and patient recruitment by the end of the current year."
- U.S. Food and Drug Administration (FDA)
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 is an immunosuppressant currently in a Canadian Phase III human clinical trial for the treatment of moderate to severe psoriasis. In addition, ISA247 has successfully completed a Phase IIa trial for kidney transplantation. The Company also has two additional immunosuppressive compounds in its drug pipeline, TAFA93 and TKB662 which are in Phase I and pre-clinical respectively.
In addition to the Company's drug pipeline, Isotechnika also has a diagnostic division, which includes the Helikit(R) and Diatest(R) breath kits. The Helikit(R) a (13)C urea breath test is used for the detection of H. pylori, a bacterium that infects a large portion of the population. The Diatest(R) a 13C glucose breath test is used to measure insulin resistance.
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.
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.
For further information:
Dr. Randall Yatscoff,
President & COO,
Ext. 246, Fax: +1-780-484-4105,
Email: [email protected];
E-mail: [email protected]
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