Fodosine (forodesine hydrochloride) is a transition state purine nucleoside phosphorylase (PNP) inhibitor, which functions by blocking the DNA synthesis machinery of the body’s T-cells.
The small molecule drug is being developed for treatment of T-cell mediated cancers, and has been designated an orphan drug for several indications, including T-cell leukemia, cutaneous T-cell lymphoma (CTCL), chronic lymphocytic leukemia (CLL) and acute lymphoblastic leukemia (ALL).
The single-center, randomized phase I study is scheduled to enroll up to 18 healthy subjects and is expected to last approximately 21 days. The trial is being conducted under fed and fast conditions, to evaluate and compare the safety, tolerability, and bioavailability of orally administered Fodosine versus intravenously administered Fodosine.
The trial is a single dose, three-period crossover study. Each subject will receive three study treatments with one treatment administered on day one of each of the three consecutive dosing periods. The treatments to be used are: oral, 300mg (three 100mg capsules) of Fodosine, fasting; oral, 300mg (three 100mg capsules) of Fodosine, fed and intravenous infusion, 40mg/m2 of Fodosine (100mL), fasting.
Results of the phase I trial will assist in facilitating design of a proposed phase IIb pivotal clinical program in patients with T-cell leukemia, using a combination of intravenous and oral formulations of Fodosine.