7:04AM Gentium: Interim results from Gentium's treatment IND for Defibrotide -- 35% of patients achieved a complete response (CR) and 55% survived to day 100 (D+100) (GENT) 56.79 : Co announced that additional data on Defibrotide were presented this week at the 55th Annual Meeting and Exposition of the American Society of Hematology at the Ernst N. Morial Convention Center in New Orleans, LA, Dec 7-10, 2013.
Professor Paul G. Richardson, RJ Corman Professor of Medicine, Clinical Director Jerome Lipper Multiple Myeloma Center, Dana-Farber Cancer Institute Harvard Medical School, Boston, MA (USA) reported, in an oral presentation, the updated results from the ongoing Treatment IND Expanded Access Protocol, a large prospective study on the use of Defibrotide in the treatment of Hepatic Veno-Occlusive Disease in hematopoietic stem cell transplant patients, (abstract # 700). This updated interim analysis was based on 470 patients with VOD, enrolled between Dec 2007 and Dec 2012 at 75 centers across the United States. 425 patients had undergone hematopoietic stem cell transplant and of those patients, 35% of patients achieved a complete response (CR) and 55% survived to day 100 (D+100).
Additional findings were as follows: In the subgroup of 284 HSCT patients with severe VOD, 29% achieved a CR and 48% survived to day 100. In the sub-group of 141 HSCT patients with non-severe VOD, 47% achieved a CR and 69 % survived to D+100. In the subgroup of 45 patients who had VOD following chemotherapy but no HSCT, 40% achieved a CR and 62% survived to D+100. Delayed initiation of Defibrotide treatment (more than 2 days after VOD diagnosis) resulted in reduced CR (25% versus 39%, p=0.0052) and survival (38% versus 61%, p=0.0001) compared to early administration (within 2 days from VOD diagnosis).
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