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Results From Gentium's Treatment IND For Defibrotide Presented At The American Society Of Hematology Annual Meeting

VILLA GUARDIA (COMO), Italy, Dec. 13, 2012 (GLOBE NEWSWIRE) -- Gentium S.p.A. (Nasdaq:GENT) (the "Company") today announced that additional data from ongoing trials of Defibrotide were presented this week at the 54 th Annual Meeting and Exposition of the American Society of Hematology (ASH) held at the Georgia World Congress Center in Atlanta, Georgia.

Dr. Paul Richardson, Clinical Director of the Dana-Farber Cancer Institute, Boston, MA (USA), reported in an oral presentation the updated results of a large prospective study on the use of Defibrotide in the treatment of Hepatic Veno-Occlusive Disease (VOD) in hematopoietic stem cell transplant patients, from the ongoing Treatment IND Expanded Access Protocol (abstract #738). The interim analysis was based on 333 patients with severe veno-occlusive disease (sVOD) and multi-organ failure (MOF), enrolled between December 2007 and September 2011 at 68 centers across the United States. 305 patients had undergone hematopoietic stem cell transplant (HSCT) and of those patients, 30% of patients achieved a complete response (CR) and 50% survived to day 100 (D+100). Additional findings were as follows:
  • In the subgroup of HSCT patients with sVOD, 26% achieved a CR and 45% survived to day 100. In patients with non-severe VOD, 39% achieved a CR and 65 % survived to D+100.
  • In the Treatment IND, 155 patients matched the entry criteria for the original Phase 3 trial and comparison to the Phase 3 historical controls showed a statistically improved outcome in CR (29% vs 9%, p=0.0019) and D+100 survival (49% vs 25%, p=0.0016)
  • Delayed initiation of Defibrotide treatment (>2 days, versus a delay of <2 days) following VOD diagnosis resulted in reduced CR (20% versus 34%, p=0.0195) and survival (37% versus 56%, p=0.0118). CR rate and D+100 survival for the 69 patients with non-severe VOD were 42% and 62%, respectively.
  • Children younger than 16 years old had higher CR rates than adults (33% vs 26%, p=0.187) and survival (56% vs 44%, p=0.277). 

Dr. Richardson also presented a poster outlining the results from the treatment of chemotherapy-induced VOD in non-stem cell transplant (non-SCT) patients enrolled in the Treatment IND Expanded Access Protocol and the Compassionate Use Program (abstract #3041). The analysis of 89 patients from the Treatment IND showed that overall 53% of patients achieved CR (53% of patients with non-severe VOD and 52% of patients with sVOD). Additionally, 68% of patients in the Compassionate Use Program were alive at D+100, and 67% were alive at D+100 in the Treatment IND. When VOD outcomes were compared to the stem cell transplant population of the Treatment IND program, 43% non-SCT patients achieved CR vs 30% in SCT patients, and survival in these patient populations was 68% and 50%, respectively.

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