Telik Reports Prelim. Deal on Design of Phase 3 Trial of Telintra in Low to Intermediate Risk Myelodysplastic Syndrome
Telik, Inc. (Nasdaq: TELK) announced the completion of an End of Phase 2 meeting with the US Food and Drug Administration (FDA). Preliminary agreement was reached regarding the design of a Phase 3 placebo-controlled randomized registration trial of Telintra (ezatiostat) for the treatment of Low to Intermediate-1 risk myelodysplastic syndrome (MDS), using red-blood-cell transfusion independence as the endpoint. In accordance with the FDA's guidance, Telik plans to complete the design of the Phase 3 registration trial. In order to focus its resources on the registration program, Telik has decided to stop further enrollment in its ongoing Phase 2 exploratory trials.
Telintra is an investigational agent in development for the treatment of MDS and idiopathic chronic neutropenia. Telintra is a novel inhibitor of the enzyme glutathione S-transferase P1‑1, leading to activation of Jun kinase, a key regulator of cellular growth and differentiation of blood precursor cells. Telintra has been shown to cause clinically significant and sustained reduction in red blood cell transfusions, transfusion independence and multilineage responses in MDS patients. The results of four clinical trials of Telintra in MDS have been reported in peer-reviewed scientific journals.
Telintra has been granted orphan drug designation by the FDA for the treatment of myelodysplastic syndrome (MDS). Orphan designation grants potential US market exclusivity to a drug for the treatment of a specified condition for a period of seven years following FDA marketing approval.
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