Post by
narcissist on Mar 12, 2012 8:04am
NEWS - Phase 3 Trials & FDA Agreement
EDMONTON, Alberta, Mar 12, 2012 (GlobeNewswire via COMTEX) -- Isotechnika Pharma Inc. CA:ISA -13.79% announced today that it has reached an agreement with the U.S. Food and Drug Administration ("FDA") on a Special Protocol Assessment ("SPA") for its planned phase 3 clinical trial of its lead product candidate, voclosporin. 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.
As previously disclosed, Isotechnika received positive Scientific Advice ("SA") from the European Medicines Agency ("EMA") on the planned Phase 3 trial in October 2011. Both the SPA and SA were received after the respective agencies reviewed Isotechnika's phase 2b data, in addition to evaluating the proposed phase 3 trial design and endpoints.
"With a clear regulatory pathway forward for voclosporin in both the United States and the European Union, we can finalize plans to initiate phase 3 testing of this potential market-leading drug to prevent kidney transplant rejection," stated Dr. Robert Foster, President & CEO. "We look forward to keeping stakeholders, including patients and physicians, apprised of our progress."
Isotechnika's voclosporin phase 3 program is expected to consist of two clinical trials run in close unison. Each trial is expected to enrol approximately 600 newly transplanted kidney patients. One trial will be conducted primarily in the United States and Canada, while the second trial will enroll patients primarily in Europe. Both phase 3 trials will aim to demonstrate non-inferiority in an efficacy endpoint, primarily driven by biopsy proven acute rejection, or BPAR, 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.
About Isotechnika Pharma Inc.
Isotechnika Pharma Inc. is a biopharmaceutical company focused on the discovery and development of immunomodulating therapeutics designed to offer key safety advantages over currently available treatments. Its lead drug, voclosporin, is a calcineurin inhibitor, and is targeted at the estimated US$3.0 billion market for this class of immunosuppressants. 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 .
We seek Safe Harbour.
This news release was distributed by GlobeNewswire, www.globenewswire.com