Gentium S.p.A. Announces Intention to Commence Phase III Trial Following Discussions with FDA
September 07 2005 - 4:00AM
Business Wire
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.
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