Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.BioCryst Pharmaceuticals has received a special protocol assessment letter from the FDA for the initiation of a pivotal clinical trial of the company's lead anticancer compound Fodosine in patients who have failed two or more previous induction therapies for acute lymphoblastic T-cell leukemia/lymphoma.
Subscribe to our email newsletter
The special protocol assessment (SPA) letter documents the agreement between FDA and BioCryst regarding the trial design’s suitability to support regulatory approval.
The multicenter, open-label, nonrandomized, repeat-dose pivotal trial is expected to commence by the end of 2006. The trial is expected to enroll approximately 100 patients with relapsed or refractory precursor T- lymphoblastic leukemia/lymphoma who have failed two or more prior treatment regimens.
The study is designed to determine the rate of complete remission achieved with this regimen of Fodosine as the primary endpoint. Secondary endpoints include assessing the safety and tolerability of extended daily treatment with this regimen, determining the effects of this regimen on survival endpoints and, evaluating the maintenance of response with this regimen.
“We would like to thank the FDA for their input and guidance during the SPA process and are pleased that the Agency has indicated agreement to proceed with this protocol,” said Dr Charles Bugg, chairman and CEO of BioCryst. “We believe Fodosine may provide a potentially important treatment option for patients suffering from T-cell and B-cell mediated cancers.”