Telik, Inc. 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.
Market News and Data brought to you by Benzinga APIs© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Comments
Loading...
Benzinga simplifies the market for smarter investing
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.
Join Now: Free!
Already a member?Sign in