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Gentium's Defibrotide Seen as Active in Multiple Myeloma

NEW YORK--(BUSINESS WIRE)--Jun 27, 2007 - Gentium S.p.A. (Nasdaq: GENT) announced the presentation of both clinical and preclinical data that support the safety, activity, synergy and potential mechanism of action of Defibrotide in combination with anticancer therapy in multiple myeloma. Investigators presented both an update from the Company's ongoing Phase I/II clinical trial for patients with refractory or relapsed multiple myeloma with Defibrotide in combination with chemotherapy, as well as a pre-clinical study demonstrating the downregulation of a key regulatory enzyme supporting a novel mechanism of action for Defibrotide in myeloma. Data from both studies was presented at the XI International Myeloma Workshop in Kos, Greece, 25-30 June, 2007.

In the first study, investigators led by Dr Antonio Palumbo of The Italian Multiple Myeloma Study Group, presented data from an ongoing multi-center, phase I/II clinical trial for relapsed or refractory multiple myeloma patients. This study is being conducted in an effort to define the maximum tolerated dose (MTD), safety and potential efficacy of the combination of melphalan, prednisone, thalidomide and Defibrotide (MPTD). Nineteen patients, who received at least three cycles of MPTD were evaluable for toxicity and response. Three escalating dose levels of Defibrotide were evaluated in combination with standard doses of melphalan, prednisone and thalidomide. No other thromboprophylaxis was administered. After a median of 3 cycles, the major response rate, including complete and partial remission was 53% (1CR, 1nCR and 7PR). Responses were seen in all three Defibrotide dose levels. Follow up remains limited and the durability of response appears favorable. MTD was not reached in any cohort. Hematological toxicities (greater than/equal to Grade 3) included neutropenia (47%), thrombocytopenia (10%), anemia (21%), non-hematological toxicities greater than/equal to grade 3 were observed in less than 5% of patients. Impor
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