FerroKin BioSciences today announced the initiation of an international Phase 2 study of FBS0701, a novel once-daily iron chelator in development for the treatment of transfusional iron overload. The Phase 2 study will assess the safety, tolerability, and pharmacodynamics of FBS0701.
"We are excited about the potential of FBS0701 in treating iron overloaded patients and the high level of enthusiasm among investigators and patients for this new drug," said Hugh Young Rienhoff, Jr., MD, founder and chief executive officer of FerroKin BioSciences. "Data from this important study will help us further establish the relative safety and efficacy of FBS0701 in this patient population and we are pleased to have begun dosing patients."
The Phase 2 open-label, 24-week study will evaluate two dose levels of FBS0701 administered orally once daily. Patients in this study will have transfusion-dependent anemias which include: hereditary anemias such as sickle cell disease, B-thalassemia, and Diamond-Blackfan anemia and acquired anemias such as myelodysplastic syndrome and other forms of bone marrow failure.
"There remains a significant clinical need for an iron chelator that is safe and well tolerated by all patients," said Ellis Neufeld, M.D., Professor of Pediatrics at Children's Hospital Boston and lead clinical investigator of the Phase 2 study.
Currently, the study is being conducted at multiple sites in the US, Middle East, Asia, and Europe. For a more detailed description of the clinical trial protocol, inclusion and exclusion criteria, and a list of participating sites, please visit clinicaltrials.gov and enter the study identifier -- NCT01186419.
Additional studies including a study of FBS0701 in the pediatric population and a Phase 3 study are being planned.