On July 19, 2016 Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3 clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, reported the enrollment of the first patient in Japan by SymBio Pharmaceuticals in the global Phase 3 INSPIRE trial, investigating IV rigosertib as a treatment for higher-risk (HR) myelodysplastic syndromes (MDS) following failure of hypomethylating agent (HMA) therapy (Press release, Onconova, JUL 19, 2016, View Source [SID:1234513960]). SymBio licensed rights to rigosertib from Onconova for Japan and Korea in 2011 and has completed two Phase 1 trials in Japan. Schedule your 30 min Free 1stOncology Demo! The INSPIRE pivotal trial is now open for patient enrollment in more than 90 sites in the U.S., Europe, Canada, Australia, Israel and Japan. The first patient in this trial was enrolled in December 2015, and so far, patients have been enrolled in six countries on four continents.
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"We are pleased to be participating in the Phase 3 INSPIRE trial for HR-MDS patients," said Fuminori Yoshida, President and CEO of SymBio. "The enrollment of the first patient in Japan for this pivotal Phase 3 trial marks an important milestone for SymBio. We believe that rigosertib has the potential to address important unmet medical needs of MDS patients in Japan. As such, beyond our participation in this study, we have also completed two Phase 1 studies and are now preparing to enroll patients in a Japanese Phase 1 trial of oral rigosertib plus azacitidine in patients with MDS."
"The initiation of the Phase 3 INSPIRE trial in Japan represents an important achievement in our collaboration with SymBio," commented Ramesh Kumar, Ph.D., President and CEO of Onconova. "In addition to participating in this trial, SymBio is also playing a key role in Japan in the development of single-agent oral rigosertib and oral rigosertib in combination with azacitidine. We look forward to providing periodic updates on the progress of the INSPIRE trial and publications and scientific presentations related to rigosertib."
The INSPIRE trial is a multi-center, randomized controlled Phase 3 study to assess the efficacy and safety of IV rigosertib in HR-MDS patients who had progressed on, failed to respond to, or relapsed, following previous treatment with HMAs. The trial will enroll approximately 225 patients randomized at a 2:1 ratio into two treatment arms: IV rigosertib plus Best Supportive Care versus Physician’s Choice plus Best Supportive Care. It is anticipated that more than 130 sites across four continents (North America, Europe, Australia and Asia) will participate in this trial. The primary endpoint of INSPIRE is overall survival and an interim analysis is anticipated.
About INSPIRE
The INternational Study of Phase III IV RigosErtib, or INSPIRE, is based on guidance received from the U.S. Food and Drug Administration and European Medicines Agency and derives from the findings of the ONTIME Phase 3 trial. INSPIRE is a multi-center, randomized controlled study to assess the efficacy and safety of IV rigosertib in HR-MDS patients who had progressed on, failed to respond to, or relapsed after previous treatment with an HMA within the first nine months of initiation of HMA treatment. This time frame optimizes the opportunity to respond to treatment with an HMA prior to declaring treatment failure, as per NCCN Guidelines.1 The trial will enroll approximately 225 patients randomized at a 2:1 ratio into two treatment arms: IV rigosertib plus Best Supportive Care versus Physician’s Choice plus Best Supportive Care. The primary endpoint of INSPIRE is overall survival and an interim analysis is anticipated. Full details of the INSPIRE trial, such as inclusion and exclusion criteria, as well as secondary endpoints, can be found on clinicaltrials.gov (NCT02562443).
About Rigosertib
Rigosertib is a small molecule inhibitor of cellular signaling and acts as a Ras mimetic. These effects of rigosertib appear to be mediated by direct binding of the compound to the Ras-binding domain (RBD) found in many Ras effector proteins, including the Raf kinases and PI3K. The therapeutic focus for rigosertib is myelodysplastic syndromes (MDS), a group of bone marrow disorders characterized by ineffective formation of blood cells that often converts into acute myeloid leukemia (AML). Clinical trials for rigosertib are being conducted at leading institutions in the U.S., Europe, and the Asia-Pacific region. Both the Intravenous (IV) and oral formulations of rigosertib are being tested in multiple clinical trials. Rigosertib is protected by issued patents (earliest expiry in 2026) and has been awarded Orphan Designation for MDS in the U.S., Europe and Japan.