Unassociated Document
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Form
6-K
REPORT
OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES
EXCHANGE ACT OF 1934
For the
month of January, 2009.
Commission
File Number 000-51341
Gentium
S.p.A.
(Translation
of registrant’s name into English)
Piazza XX
Settembre 2, 22079 Villa Guardia (Como), Italy
(Address
of principal executive office)
Indicate
by check mark whether the registrant files or will file annual reports under
cover of Form 20-F or Form 40-F.
Form 20-F
S Form
40-F o
Indicate
by check mark if the registrant is submitting the Form 6-K in paper as permitted
by Regulation S-T Rule 101(b)(1): ____
Note: Regulation S-T Rule
101(b)(1) only permits the submission in paper of a Form 6-K if submitted solely
to provide an attached annual report to security holders.
Indicate
by check mark if the registrant is submitting the Form 6-K in paper as permitted
by Regulation S-T Rule 101(b)(7): ____
Note: Regulation S-T Rule
101(b)(7) only permits the submission in paper of a Form 6-K if submitted to
furnish a report or other document that the registrant foreign private issuer
must furnish and make public under the laws of the jurisdiction in which the
registrant is incorporated, domiciled or legally organized (the registrant’s
“home country”), or under the rules of the home country exchange on which the
registrant’s securities are traded, as long as the report or other document is
not a press release, is not required to be and has not been distributed to the
registrant’s security holders, and, if discussing a material event, has already
been the subject of a Form 6-K submission or other Commission filing on
EDGAR.
Indicate
by check mark whether the registrant by furnishing the information contained in
this Form is also thereby furnishing the information to the Commission pursuant
to Rule 12g3-2(b) under the Securities Exchange Act of 1934. Yes o No S
If “Yes”
is marked, indicate below the file number assigned to the registrant in
connection with Rule 12g3-2(b):
82-_______________.
The
Registrant's press release regarding completed enrollment of the Phase II/III
European Pediatric Prevention Trial is attached hereto as Exhibit 1 and
incorporated by reference herein in its entirety. This report and the
exhibit attached thereto are incorporated by reference into the registration
statements of Gentium S.p.A. on Forms F-3: File No. 333-135622, File
No. 333-137551, File No. 333-138202, File No. 333-139422 and File No. 333-141198
and on Forms S-8: File No. 333-137534 and File No. 333-146534.
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1
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Press
release, dated January 22,
2009.
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SIGNATURE
Pursuant to the requirements of the
Securities Exchange Act of 1934, the registrant has duly caused this report to
be signed on its behalf by the undersigned thereunto duly
authorized.
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GENTIUM S.P.A.
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By:
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/s/ Gary G. Gemignani
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Name:
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Gary
G. Gemignani
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Title:
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Executive
Vice President and Chief Financial
Officer
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Date:
January 27, 2009
INDEX
TO EXHIBITS
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1
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Press
release, dated January 22, 2009.
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Gentium
Announces Completion of Enrollment for the Phase II/III European Pediatric
Prevention Trial of Defibrotide
VILLA
GUARDIA (Como), Italy, January 22, 2009 (BUSINESS WIRE) -- Gentium S.p.A.
(Nasdaq: GENT) announced today the completion of patient enrollment in a Phase
II/III European, multi-center, open label, randomized trial to evaluate the
prophylactic use of Defibrotide in pediatric patients undergoing stem cell
transplantation who are at high risk for hepatic veno-occlusive disease
(VOD).
In the
Phase II/III trial, patients are randomly assigned to one of two treatment arms.
Those allocated to the Defibrotide prophylaxis arm receive 25mg/kg/day in four
divided doses beginning at the time of conditioning and finishing 30 days after
stem cell transplantation (SCT) or upon discharge from inpatient
care. Patients allocated to the control arm do not receive VOD
prophylactic measures. The primary efficacy endpoint for the trial is
the incidence of VOD within 30 days after SCT. The secondary safety endpoints
include the occurrence of multi-system organ failure and survival at 100 days
after SCT. Additional information on this trial can be found at
www.clinicaltrials.gov.
Gentium
plans to release initial results of this trial at the Annual Meeting of the
European Group for Blood and Marrow Transplantation, March 29 to April 1, 2009
in Göteborg, Sweden. As was previously announced, following
discussions with the European Medicines Agency, Gentium has been notified of the
potential for an accelerated review of Defibrotide in the pediatric prevention
indication.
“We are
excited to have completed enrollment in our European Phase II/III prophylaxis
trial for Defibrotide in pediatric patients,” stated Dr. Laura Ferro, CEO of
Gentium S.p.A. “Prior investigator sponsored trials for Defibrotide in the
prevention setting have shown promising results, and we are hopeful that this
trial will fall in line with what we have previously seen.”
About
VOD
Veno-occlusive
disease is a potentially life-threatening condition, which typically occurs as
an important complication of stem cell transplantation. Certain high-dose
chemo-radiation therapy regimens used as part of SCT can damage the lining cells
of 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). 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, including clinical trial results and regulatory
reviews, may differ 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 20F filed with the
Securities and Exchange Commission under the caption “Risk
Factors.”
###
Contacts:
Gentium
S.p.A.
Gary
Gemignani, +1 212-332-1666
Chief
Financial Officer
ggemignani@gentium.com
The Trout
Group
Marcy
Strickler, +1 646-378-2927
mstrickler@troutgroup.com
Lifonti
& Company
Luca
Ricci Maccarini, +39 02 7788871
luca.maccarini@lifonti.it