Unassociated Document
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 March, 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 □
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 regarding preliminary results to the phase 2/3
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.
Exhibit Description
1
Press release, dated March 29,
2009.
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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Date:
March 30, 2009
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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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INDEX
TO EXHIBITS
Exhibit Description
1
Press release, dated March 29,
2009.
Gentium
Announces Preliminary Results from a Phase 2/3 European
Pediatric Prevention
Trial for Veno-Occlusive Disease at the European
Group for Blood and Marrow
Transplantation Annual Meeting
VILLA
GUARDIA (Como), Italy, March 29, 2009 (BUSINESS WIRE) -- Gentium S.p.A. (Nasdaq:
GENT) today presented preliminary unaudited top-line results from the Phase 2/3
European pediatric prevention clinical trial of Defibrotide. The
results were presented by Selim Corbacioglu, Department of Pediatrics,
University of Ulm, Germany, principal investigator of the clinical trial, at the
Annual Meeting of the European Group for Blood and Marrow Transplantation (EBMT)
in Göteborg, Sweden.
The Phase
2/3 European pediatric prevention trial is a multi-center, open label,
randomized clinical 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 this two-armed trial,
patients were randomly assigned to receive Defibrotide. Patients in
the prophylaxis arm received 25 mg/kg/day of Defibrotide in four divided doses
beginning at the time of conditioning. Patients in the control arm,
however, did not receive Defibrotide for VOD prophylactic
measures. The primary endpoint of the study was development of VOD
within 30 days post stem cell transplantation (SCT) based on the modified
Seattle criteria.
The
results from this clinical trial demonstrated a 40% reduction in incidence of
VOD within 30 days after SCT and achieved a statistical P-value of 0.0539, with
a hazard ratio of 1.68 (95% confidence interval of 0.98-2.86), in the
intent-to-treat analysis of 180 patients in the prophylaxis arm and 176 patients
in the control arm. In addition, the analysis of data pursuant to the
protocol (patients who completed 30 days in the study), which included 164
patients in the prophylaxis arm and 169 patients in the control arm, showed a
40% reduction rate of the incidence of VOD within 30 days and achieved a
statistical P-value of 0.0366, with a hazard ratio of 1.78 (95% confidence
interval of 1.03-3.08). The data also demonstrated the excellent safety profile
of Defibrotide showing no difference in adverse events between the prophylaxis
and control arms.
“We are
encouraged by the preliminary results from the Phase 2/3 trial of Defibrotide to
prevent VOD in children and anticipate announcing the final results in the
second half of 2009,” commented Dr. Laura Ferro, CEO of Gentium
S.p.A. “We look forward to sharing the final results with the
European Medicines Agency in order to determine the necessary steps for
potential approval. In addition, we are hopeful that the progress
indicated by the preliminary data will provide us with potential opportunities
to allow us to complete the clinical and regulatory process so that we can
provide patients with Defibrotide for this critical and unmet
need.”
“The
results seen in this study provide a compelling case for a novel, safe,
effective, therapeutic option for preventing VOD in pediatric patients
undergoing SCT who have multiple unfavorable prognostic factors,” said Professor
Dietger Niederwieser, Department of Hematology and Oncology, University of
Leipzig and President of the European Group for Blood and Marrow
Transplantation.
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 chemotherapy or radiation
treatments 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
Nanus, +1 646-378-2927
mnanus@troutgroup.com
Lifonti
& Company
Luca
Ricci Maccarini, +39 02 7788871
luca.maccarini@lifonti.it