Gentium Announces Completion of Data Safety Monitoring Board Review and Continuation...

Gentium Announces Completion of Data Safety Monitoring Board Review and Continuation of the Phase II/III European Pediatric Prevention Trial of Defibrotide

VILLA GUARDIA, Italy--(Business Wire)--
Gentium S.p.A (NASDAQ: GENT) announced today that an independent
Data Safety Monitoring Board (DSMB) has completed the planned interim
analysis for the Company's Phase II/III multi-center, open label,
randomized trial in Europe to evaluate prophylactic use of Defibrotide
in pediatric patients undergoing stem cell transplantation at high
risk for hepatic veno-occlusive disease (VOD). The interim analysis
was performed subsequent to the enrollment of 240 patients.

The DSMB concluded that there are no significant safety concerns,
the prophylactic treatment arm (Defibrotide) and the control arm (no
drug) are well balanced, and there is no evidence of clinical futility
in the trial. Further, the DSMB indicated that the results to date
were satisfactory and recommended that the trial continue to accrue
patients. The DSMB also recommended increasing total patient
enrollment to 180 patients per arm from 135 patients per arm to
achieve a more statistically significant benefit of Defibrotide over
the control. There are no further planned interim analyses for this
trial.

"The DSMB's recommendation is very encouraging and we await the
final outcome of this key trial with great interest," said Dr. Dietger
Niederwieser, Department of Hematology and Oncology, University of
Leipzig and President of the European Group for Blood and Marrow
Transplantation, the co-sponsor of the trial. "I am hopeful that the
results will be consistent with the promising data from earlier
published studies in prophylaxis and support the efficacy of
Defibrotide in preventing VOD."

"We are pleased with the DSMB's review and are following their
recommendation to accrue 180 patients in each arm of the study," said
Dr. Laura Ferro, Chairman and Chief Executive Officer of Gentium.
"There are currently 276 patients enrolled in the trial and we plan to
complete enrollment around year-end and report top-line results during
the first half of 2009. We have also been advised recently by EMEA
that our planned filing in this indication could be eligible for an
accelerated review, which could reduce the review cycle from seven
months to five."

Gentium will host a conference call today, June 5, 2008 at 5:00
p.m. (ET) to discuss this press release and the other press release
issued today by the Company regarding clinical trial matters for
Defibrotide.

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Dial-in Information:
US/Canada Toll-Free callers: 877-407-8031
US/Canada Toll or International Toll callers: 201-689-8031
*T

Live audio of the conference call will be simultaneously broadcast
over the internet via a webcast. To access the live webcast, log on to
the Gentium's corporate website at http://www.gentium.com

A replay of the call also will be available until 11:59 PM US
Eastern Time on June 12, 2008. To access the replay, dial
1-877-660-6853 from the US or Canada (toll-free) or 1-201-612-7415
from other locations, and enter account #286 and conference ID#287992.
Additionally, an archived replay of the conference web cast will be
available on the Gentium website for 30 days.

About VOD

Veno-occlusive disease (VOD) is a potentially life-threatening
condition, which typically occurs as an important complication of stem
cell transplantation (SCT). Certain high-dose chemo-radiation therapy
regimens used as part of SCT can damage the cells lining the hepatic
blood vessels and so result in VOD, a blockage of the small veins of
the liver that leads to liver failure and can result in significant
dysfunction in other organs such as the kidneys and lungs (so called
severe VOD with multiple organ failure). SCT is a frequently used
treatment modality following high-dose chemotherapy and radiation
therapy for hematologic cancers and other conditions in both adults
and children. There is currently no approved agent for the treatment
or prevention of 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, is an investigational drug that has
been granted Orphan Drug status by the U.S. Food and Drug
Administration and EMEA to prevent and to treat VOD and Fast Track
designation by the U.S. FDA for the treatment of severe VOD in
recipients of stem cell transplants.

Cautionary Note Regarding Forward-Looking Statements

This press release contains "forward-looking statements." In some
cases, you can identify these statements by forward-looking words such
as "may," "might," "will," "should," "expect," "plan," "anticipate,"
"believe," "estimate," "predict," "potential" or "continue," the
negative of these terms and other comparable terminology. These
statements are not historical facts but instead represent the
Company's belief regarding future results, many of which, by their
nature, are inherently uncertain and outside the Company's control. It
is possible that actual results may differ, possibly materially, from
those anticipated in these forward-looking statements. For a
discussion of some of the risks and important factors that could
affect future results, see the discussion in our Form 20-F filed with
the Securities and Exchange Commission under the caption "Risk
Factors."

Gentium S.p.A.
Gary Gemignani, +1 212-332-1666
Chief Financial Officer
ggemignani@gentium.com
or
The Trout Group
Marcy Strickler, +1 646-378-2927
mstrickler@troutgroup.com
or
Lifonti & Company
Luca Ricci Maccarini, +39 02 7788871
luca.maccarini@lifonti.it

Copyright Business Wire 2008