Gentium S.p.A. Announces Intention to Commence Phase III Trial Following Discussions with FDA

Gentium S.p.A. (AMEX:GNT) (the "Company") announced
today that on September 6, 2005, representatives of the Company,
including members of management and the scientific advisory board, met
with officials at the U.S. Food and Drug Administration (FDA) to
discuss the Company's proposed Phase III clinical trial for the use of
Defibrotide for the treatment of hepatic veno-occlusive disease
("VOD") with multi-organ failure ("Severe VOD"). At that meeting, the
FDA encouraged the Company to conduct further studies of Defibrotide
to treat VOD, including Severe VOD. The FDA also provided the Company
with constructive comments regarding certain aspects of the trial
protocol. Following these discussions with the FDA, the Company, with
input from its expert consultants, plans to finalize the trial
protocol and, during the fourth quarter of 2005, commence the Phase
III clinical trial for this indication using an historical control
group.
   Defibrotide, which has been granted orphan drug status for the
treatment of Severe VOD and fast track designation for the treatment
of Severe VOD in recipients of stem cell transplants, is the Company's
lead product candidate in the U.S.
   Dr. Laura Ferro, Chairman and Chief Executive Officer of the
Company, said: "The Company appreciates the FDA's comments and intends
to proceed with initiation of the Phase III trial by the end of the
year. With no currently approved treatment options available, we
believe there is an urgent need for a therapy for Severe VOD, and
Defibrotide has shown promise in treating this devastating condition."

   About Severe VOD

   Severe VOD is a potentially life-threatening condition in which
some of the veins in the liver are blocked as a result of toxic cancer
treatments such as chemotherapy, radiation, hormone therapy, and bone
marrow and stem cell transplants. Based on the Company's review of
more than 200 published papers in the medical literature, it is
estimated that approximately 80% of patients with Severe VOD die
within 100 days without treatment. There are no currently approved
treatments for Severe VOD.

   About the Company

   The Company, located in Como, is a biopharmaceutical company
focused on the research, discovery and development of drugs derived
from DNA extracted from natural sources and drugs which are synthetic
derivatives (molecules chemically similar to natural DNA) to treat and
prevent a variety of vascular diseases and conditions related to
cancer and cancer treatments.

   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 Prospectus filed with
the Securities and Exchange Commission under Rule 424(b)(4) under the
caption "Risk Factors."
   Submission and filing of a New Drug Application ("NDA") for the
use of Defibrotide to treat Severe VOD is subject to the Company
obtaining positive results from its Phase III trial. There can be no
assurance that the Company will obtain approval of an NDA to use
Defibrotide for this or any other use regardless of the outcome of the
trial.