EDMONTON, Alberta, Nov. 26, 2012 (GLOBE NEWSWIRE) -- Isotechnika Inc. (TSX:ISA) ("Isotechnika" or the "Company") announced today that it has received permission from the U.S. Food and Drug Administration ("FDA") to commence the first of two planned phase 3 kidney transplant trials for its lead product candidate, voclosporin.
As previously disclosed, Isotechnika reached an agreement with the FDA on a Special Protocol Assessment ("SPA") for this planned phase 3 study in March 2012. The SPA is a written agreement with the FDA that the phase 3 clinical study design, endpoints, statistical analyses, and other aspects of the planned study are acceptable to support marketing approval. The SPA was received after the FDA reviewed Isotechnika's phase 2b data and evaluated the proposed phase 3 trial design and endpoints.
The planned randomized, multi-center phase 3 trial will include approximately 600 de novo (newly transplanted) kidney patients from clinical trial sites across North America. The primary endpoint of the trial will be defined as non-inferiority in biopsy proven acute rejection, or BPAR, episodes with patients receiving voclosporin for six months as compared to tacrolimus. A key secondary endpoint will be the incidence of New Onset Diabetes After Transplantation, or NODAT, as well as the overall safety and tolerability of voclosporin relative to tacrolimus.
"We are very pleased to receive this clearance from the FDA to initiate phase 3 testing of voclosporin, a potential market-leading drug to prevent kidney transplant rejection," commented Dr. Robert Foster, Isotechnika's President and CEO. "Many of North America's most prestigious trial sites and renowned clinical investigators have expressed interest in participating in this study and, subject to the Company securing adequate financial resources, we expect to launch patient recruitment in the first half of 2013."
We seek Safe Harbor.
About Isotechnika Pharma Inc.
Isotechnika Pharma Inc. is a biopharmaceutical company advancing a late-stage immunosuppressive drug, voclosporin, which offers key safety advantages over currently available calcinuerin inhibitors; a market estimated to be US$3 billion worldwide. Its earlier stage pipeline focuses on inhibition of various cyclophilins and the company is currently working on lead optimization in collaboration with the National Research Council of Canada Industrial Research Assistance Program (NRC-IRAP) and the U.S. National Institutes of Health (NIH). Isotechnika Pharma Inc. trades on the Toronto Stock Exchange under the symbol "ISA". More information on Isotechnika Pharma can be found at www.isotechnika.com or www.sedar.com.