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Onconova announces FDA agreement of a SPA for a pivotal phase 3 trial of Estybon in MDS
Date:10/4/2010

innovative therapy for cancer patients," said Michael Hoffman, Chairman, Board of Directors of Onconova. "We are optimistic that the strikingly positive results from ongoing trials, combined with the anticipated data from this registration trial, will help establish the utility of Estybon in this patient population, presently facing limited treatment options. We are also pursuing solid tumor indications for Estybon which is broadly active in a variety of tumor types."

Dr. Francois Wilhelm, Chief Medical Officer of Onconova added, "The Phase 1 and 2 Estybon data which were presented at the Best of ASH session of the 2009 ASH conference, demonstrated promising activity and outcomes for MDS patients treated with Estybon and provided heightened awareness of the potential therapeutic role of a Cyclin D targeted therapy for these patients."

"The Leukemia & Lymphoma Society (LLS) is committed to the rapid advancement of therapies that have strong potential for the treatment of patients with MDS" said Louis J. DeGennaro, LLS Chief Mission Officer. "LLS continues its support for the development of Estybon through our collaboration with Onconova announced in June 2010. We see this SPA as a significant step toward making this drug available to patients. "


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