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 November, 2008.
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 □
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 □ 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 which
provides an update on the Phase 3 treatment trial of Defibrotide for Severe
Veno-Occlusive Disease 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.
|
Exhibit
|
Description
|
|
1
|
Press
release, dated November 19,
2008.
|
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.
| |
GENTIUM
S.P.A.
|
| |
|
|
|
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|
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By:
|
/s/
Gary G. Gemignani
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Name:
|
Gary
G. Gemignani
|
| |
|
Title:
|
Executive
Vice President and Chief Financial
Officer
|
Date:
November 19, 2008
INDEX
TO EXHIBITS
|
Exhibit
|
Description
|
|
1
|
Press
release, dated November 19, 2008.
|
Exhibit
1
PRESS
RELEASE
Gentium
Provides an Update on the Phase 3 Treatment Trial of Defibrotide for Severe
Veno-Occlusive Disease
Results
from Data Safety Monitoring Board Review
Assessment
of Historical Control Arm by Independent Medical Review
Committee
VILLA
GUARDIA (Como), Italy, November 19, 2008 (BUSINESS WIRE) -- Gentium S.p.A.
(NASDAQ: GENT) announced today interim results from an independent Data Safety
Monitoring Board (DSMB) review of the Company's Phase 3 treatment trial of
Defibrotide for Severe Veno-Occlusive Disease (VOD). The DSMB reported that
in
order for the study to be 80% powered to detect a p-value of .01, the necessary
statistical hurdle under the current protocol for FDA approval, the sample
size
should be increased to 160 patients in the treatment arm and 80 patients in
the
historical control arm. The DSMB also noted that a sample size of 102 patients
in the treatment arm and 51 patients in the historical control arm would be
needed to achieve a p-value of .05. Furthermore, the DSMB indicated that the
data presented thus far do not raise any safety concerns and did not recommend
that the trial be stopped for futility.
Gentium
also announced today the preliminary results of an independent Medical Review
Committee’s (MRC) selection of historical control patients in the trial.
Following the results of a prior DSMB meeting announced on June 5, 2008 in
which
the DSMB expressed concerns regarding the practical application of the criteria
used to enroll historical control patients, the MRC met to re-review the
criteria and eligibility of all historical control cases. After reviewing the
available information, the MRC was only able to conclude that 32 out of the
86
patients initially included in the historical control arm definitively met
the
eligibility criteria and had a confirmed diagnosis of severe VOD. There are
currently 102 patients enrolled in the treatment arm of the study.
“While
we
were hoping to be in a better position following the reviews of the DSMB and
MRC
concerning our Phase 3 trial, we remain committed to the development of
Defibrotide,” said Dr. Laura Ferro, CEO of Gentium. “We do not intend to enroll
the additional number of patients required to achieve a p-value of .01; however,
we are evaluating the possible enrollment of additional patients in the
historical control arm, which would allow us greater potential to achieve a
p-value that could be used as supportive data in favor of an approval of
Defibrotide.”
“We
are
currently in discussions with our corporate partner regarding the future
development of Defibrotide and are also evaluating our strategic options for
the
Company,” said Gary Gemignani, CFO of Gentium. “We continue to make progress in
our European Pediatric Phase 2/3 prevention trial. To date, 345 out of 360
patients have been enrolled and we look forward to reporting results in
2009.”
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.”
###
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