BioCryst agrees SPA for pivotal oral Fodosine trial

Alabama, USA-based BioCryst Pharmaceuticals says that it has reached an agreement with the Food and Drug Administration under its Special Protocol Assessment process for the design of its planned pivotal clinical trial of the oral formulation of the company's lead oncology compound, Fodosine (forodesine HCl) in patients with cutaneous T-cell lymphoma. BioCryst requested the formal SPA late in the first quarter of 2this year, because the pivotal trial is intended to form the primary basis of an efficacy claim in the planned New Drug Application for oral Fodosine.

The multicenter, multinational, open-label, single-arm, repeat-dose pivotal trial is expected to initiate enrollment during the third quarter of 2007. The trial will enroll patients with CTCL of Stage IB through Stage IVA who have disease that is persistent, progressive or recurrent during or after treatment with at least three systemic therapies. The study's primary endpoint is to determine the objective response rate, defined as either complete response or partial cutaneous response, achieved with a once-daily oral regimen of Fodosine. Secondary endpoints include assessing the safety and tolerability of extended daily treatment with oral Fodosine, assessment of the time to objective response and the duration of objective response.