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 August, 2009.
Commission
File Number 000-51341
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Gentium S.p.A.
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(Translation
of registrant’s name into English)
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Piazza XX Settembre 2, 22079 Villa Guardia (Como),
Italy
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(Address
of principal executive office)
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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): o
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): o
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 results from its Phase III treatment 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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Exhibit
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Description
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1
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Press
release, dated August 19, 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:
August 19, 2009
INDEX
TO EXHIBITS
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Exhibit
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Description
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1
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Press
release, dated August 19, 2009.
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Gentium
Reports Top Line Results from the Phase III Treatment Trial of
Defibrotide
for Severe Veno-Occlusive Disease
VILLA
GUARDIA (Como), Italy, August 19, 2009 (BUSINESS WIRE) -- Gentium S.p.A.
(NASDAQ: GENT) today announced top-line results from a historically controlled,
multicenter, open label, Phase III trial designed to evaluate the safety and
efficacy of 25 mg/kg/day of Defibrotide for the treatment of severe
veno-occlusive disease (sVOD) in hematopoietic stem cell transplant (SCT)
patients. The results demonstrate strong trends in favor of the
Defibrotide-treated patients for complete response and survival, but did not
reach the protocol-specified levels of significance for the primary and
secondary endpoints at 100 days. With regard to safety, adverse events
were well balanced between the historical control and treatment arms. The
Company plans to present full results from this trial at the American Society of
Hematology Conference in New Orleans, LA, December 5-8, 2009.
The
primary endpoint of the trial was complete response at 100 days following SCT
and utilized historical controls (patients who in the past received the best
therapy and supportive care available at the time, but not Defibrotide) as a
comparator. Secondary endpoints included survival rate at 100 days and six
months post SCT. The historical control database was generated through a
sequential, retrospective medical chart review, with final selection of the
control group performed by an independent medical review committee (MRC).
The MRC remained blinded to patient outcome data throughout the duration of the
trial. Per the study protocol, data in the primary efficacy analysis were
adjusted by quintiles of propensity score based on four stratification variables
(allogeneic/autologous SCT, adult/pediatric, one/two+ SCTs, and
ventilator/dialysis dependence) to aid in obtaining balance between the
treatment and historical control arms in a non-randomized trial. As a
stand-alone trial utilizing a historical control arm, the study protocol
specified a p-value of less than or equal to 0.01 for the primary endpoint to
achieve statistical significance, while the secondary endpoints required a
p-value of less than or equal to 0.05, the more common threshold for statistical
significance.
123
patients with symptoms consistent with VOD were identified and then reviewed for
eligibility in the historical control arm by the MRC, with 32 cases selected as
having an unequivocal diagnosis of sVOD (graft versus host disease was ruled
out) and met all protocol-required entry criteria. 102 patients were enrolled in
the Defibrotide treatment group and baseline characteristics were balanced
between the two arms.
For the
primary efficacy analysis on an intent to treat basis, 24% of patients in the
Defibrotide arm compared to 9% of patients in the historical control arm
achieved complete response at 100 days (p-value = 0.015). For the
secondary efficacy analysis on an intent to treat basis, 38% of patients in the
Defibrotide arm compared to 25% of patients in the historical control arm
demonstrated survival at 100 days (p-value = 0.051). Thus, while the primary
endpoint achieved a p-value less than 0.05 and the secondary endpoint showed a
strong trend towards statistical significance, neither reached the level of
significance required in the protocol for proof of efficacy with a single
study.
“I am
encouraged by the results of this trial, especially given the extremely sick
patient population that was enrolled,” said Dr. Paul Richardson, Clinical
Director of the Dana-Farber Cancer Institute’s Jerome Lipper Multiple Myeloma
Center and principal investigator of the trial. “The data generated from
this trial confirms the activity of Defibrotide seen in earlier studies, and
supports the benefit of Defibrotide for the treatment of sVOD in improving
complete response rates and survival, as well as its potential in less advanced
stages of the disease.”
“Given
the outcome of the data safety monitoring board’s interim review announced in
November of last year, we expected that reaching the required statistical
threshold for a single trial would be difficult,” said Gary Gemignani, Executive
Vice-President and Chief Financial Officer. “We are pleased that the data
are compelling and believe the results place us in a strong position to continue
discussions with the FDA and others regarding next steps toward a regulatory
filing. Additionally, we plan on announcing final results from our
randomized, pediatric prevention study in the upcoming weeks.”
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., located in Como, Italy, is a biopharmaceutical company focused on the
research, discovery and development of drugs 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 and Fast Track Designation by the U.S.
FDA to treat Severe VOD and Orphan Medicinal Product Designation by the European
Commission both to treat and to prevent VOD.
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.”
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Contacts:
Gentium
S.p.A.
Gary
Gemignani, +1 212-332-1666
Chief
Financial Officer
ggemignani@gentium.com
The Trout
Group
Christine
Labaree, +1 617 583 1307
clabaree@troutgroup.com
Lifonti
& Company
Luca
Ricci Maccarini, +39 02 7788871
luca.maccarini@lifonti.it