CTN Accepted for SymBio’s Japan Phase 1 Trial of Rigosertib (SyB L-1101)
News Sep 27, 2012
SymBio Pharmaceuticals Limited has announced that clinical trial notification (CTN) has been accepted for its Phase 1 clinical trial using rigosertib (SyB L-1101) in refractory and relapsed myelodysplastic syndrome (MDS) patients.
Onconova Therapeutics, Inc., a U.S.-based biopharmaceutical company which has licensed rigosertib to SymBio, is conducting late-stage clinical trials with rigosertib (ON 01910.Na) in the U.S., Europe and India in hematological cancers and solid tumors.
A pivotal Phase III trial in refractory/relapsed MDS patients was initiated under a Special Protocol Assessment from the U.S. FDA and is underway at more than 50 centers in the U.S. and Europe.
The U.S. FDA has granted orphan drug designation for the use of rigosertib in MDS and pancreatic cancer.
In addition to the intravenous product in advanced-stage development and with the successful completion of two Phase I trials, an oral formulation of rigosertib is being developed for frontline MDS in Phase II trials and other indications.
To date, more than 500 cancer patients have been treated with rigosertib in Phase I, II and III clinical trials conducted in the U.S., EU and India.
As well as this first trial for the treatment of refractory and relapsed MDS patients, SymBio is planning to initiate a Phase I clinical trial for the treatment of frontline MDS using the oral form of rigosertib (SyB C-1101) based on promising results generated in U.S. Phase II clinical trials.
Patients with MDS often require frequent blood transfusions due to the development of severe anemia (decrease in number of red blood cells), with approximately one third of patients progressing to acute myelogenous leukemia (AML).
MDS remains an underserved therapeutic area with few available treatment options for patients, hence SymBio is moving rigosertib through clinical development as nimbly as possible.