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www.fdanews.com/articles/81502-telik-receives-clearance-from-fda-to-conduct-telintra-studies

TELIK RECEIVES CLEARANCE FROM FDA TO CONDUCT TELINTRA STUDIES

October 7, 2005

Telik has received permission to proceed, under an investigational new drug application filed with the FDA, with the clinical study of an oral formulation of Telintra. The initial clinical trial will be conducted in patients with myelodysplastic syndrome (MDS) and is in addition to the ongoing clinical trial using the parenteral formulation of Telintra. The oral formulation of Telintra, if successfully developed, may permit evaluation in additional clinical indications.

Telintra is a novel small molecule that has been shown in preclinical testing to have myelorestorative activity when administered orally or by infusion.

Myelodysplastic syndromes are a group of bone marrow disorders characterized by the abnormal formation, development and maturation of blood elements. In some cases, MDS progresses to acute leukemia. There are an estimated 10,000 to 15,000 new cases of MDS diagnosed annually in the U.S., according to the American Cancer Society.