Conducted at the University of Texas MD Anderson Cancer Center, this single-site phase II, open label trial will evaluate the efficacy and safety of Fodosine as determined by response rate, time to disease progression, and patient tolerance. Patients will receive orally administered Fodosine at a dose of 200 mg for four weeks.
After this first full cycle of therapy, patients will be evaluated and responding patients, or patients with stable disease, will be allowed to receive further treatment cycles up to a maximum of six cycles. The study is scheduled to enroll up to 30 patients.
“Through data gathered in our multiple clinical and preclinical studies of Fodosine, we believe the drug may provide an important treatment option for patients suffering from both T-cell and B-cell mediated leukemias, including chronic lymphocytic leukemia,” stated Dr Charles Bugg, chairman and CEO of BioCryst. “Additionally, we believe providing an oral formulation of Fodosine will address some of the important quality of life issues faced by fludarabine-refractory CLL patients.”