Prophylactic Treatment with Defibrotide in Post Transplant Patients May Reduce Incidence of Death in VOD

Gentium S.p.A. (Nasdaq: GENT) announced the publication of the
results of an independent clinical study supporting the prophylactic
treatment of patients post allogeneic stem cell transplant with
Defibrotide as a preventative therapy for veno-occlusive disease, a
deadly complication frequent in patients who receive stem cell
transplants. Results of the study demonstrated the effectiveness of
treatment with Defibrotide in reducing both the incidence of VOD, as
well as potentially severe hemorrhagic complications. The data from
the Royal Marsden Hospital in the UK were published in the May 14th
issue of the journal Bone Marrow Transplantation.

In this study, patients received Defibrotide twice a day for
twenty-one days. Patients did not receive concurrent heparin therapy.
Fifty-eight patients, all of whom had received allogeneic stem cell
transplant, were treated with Defibrotide. No patients met the
Baltimore criteria for VOD and no patients died of suspected VOD
within 100 days of transplantation. The transplant related mortality
(TRM) within 100 days was 5/58 (8.6%) of patients. VOD was not felt to
have contributed to the deaths of any of these patients. Patients
tolerated Defibrotide well and the drug did not have to be
discontinued in any patient. There were no cases of hemorrhagic
complications attributable to Defibrotide.

"We are pleased with the results of this study and believe that
they are supportive of the ongoing Phase 2/3 pivotal trial evaluating
the incidence and outcome of VOD with the prophylactic use of
Defibrotide in pediatric stem cell transplantation patients,"
commented Laura Ferro, M.D., President and CEO of Gentium. "We hope
that the results published will translate into a positive outcome for
patients in our ongoing trial."

For review of the abstract of this publication please see:
http://www.nature.com/bmt/journal/vaop/ncurrent/abs/1705696a.html

Defibrotide is an investigational drug that has been granted
Orphan Drug status by the U.S. Food and Drug Administration to prevent
and to treat severe veno-occlusive disease (VOD) and Fast Track
designation for the treatment of severe VOD in recipients of stem cell
transplants. Defibrotide is currently in a U.S. Phase III trial to
treat severe VOD and a European Phase II/III trial to prevent VOD in
pediatric patients.

About VOD

Veno-occlusive disease (VOD) is a potentially life-threatening
condition. Certain high-dose chemotherapy and radiation therapies and
stem cell transplantation (SCT) can damage cells of the blood vessels
and result in VOD, a blockage of the small veins of the liver that can
lead to liver failure and the failure of other organs (severe VOD).
SCT is a frequently used treatment following high-dose chemotherapy
and radiation therapy. The International Bone Marrow Transplant
Registry estimated that in 2002 approximately 45,000 people received
blood and bone marrow transplants, which are types of SCT. Based on
the Company's review of more than 200 published papers, it believes
that approximately 20% of patients who undergo SCT develop VOD,
approximately one-third of those who develop VOD progress to severe
VOD and approximately 80% of severe VOD patients die within 100 days
of the SCT. The Company believes that there are no approved therapies
to treat or prevent VOD in the U.S. or the EU.

About Gentium

Gentium S.p.A. is a biopharmaceutical company focused on the
research, discovery and development of drugs derived from DNA
extracted from natural sources, and drugs that are synthetic
derivatives, to treat and prevent a variety of vascular diseases and
conditions related to cancer and cancer treatments. Defibrotide, the
Company's lead product candidate in the U.S., is an investigational
drug that has been granted Orphan Drug status by the U.S. Food and
Drug Administration to prevent and to treat VOD and Fast Track
designation for the treatment of severe VOD in recipients of stem cell
transplants.

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