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 June, 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 releases are attached hereto as Exhibits 1 and 2 and
incorporated by reference herein in their entirety. This report and the exhibits
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 June 5,
2008. |
| 2 |
Press release, dated June 5,
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. |
|
|
|
| |
By: |
/s/ Gary
G.
Gemignani |
| |
Name: Gary
G. Gemignani |
| |
Title:
Chief
Financial Officer |
Date:
June 5, 2008
INDEX
TO EXHIBITS
| Exhibit |
Description |
| 1 |
Press release, dated June 5,
2008. |
| 2 |
Press release, dated June 5,
2008. |
FOR
IMMEDIATE RELEASE
Company
Contact:
Gary
G.
Gemignani
Chief
Financial Officer
212-332-1666
ggemignani@gentium.com
Investor
Relations Contacts:
U.S.
The
Trout
Group
Laura
Okpala, 617-583-1306
lokpala@troutgroup.com
Marcy
Strickler, 646-378-2927
mstrickler@troutgroup.com
Italy:
Lifonti
& Company
Luca
Ricci Maccarini
luca.maccarini@lifonti.it
+39
027788871
Gentium
Announces Update from Data Safety Monitoring Board Review of the Phase III
Treatment Trial of Defibrotide for Severe Veno-Occlusive
Disease
VILLA
GUARDIA (Como), Italy, June 5, 2008 (BUSINESS WIRE) -- Gentium S.p.A (NASDAQ:
GENT)
announced today that an independent Data Safety Monitoring Board (DSMB) has
provided an update on the planned interim analysis for the Company's Phase
III,
historically controlled, multi-center study of Defibrotide for the treatment
of
severe veno-occlusive disease in hematopoietic stem cell transplant patients.
The DSMB meeting was conducted after
data relating to the primary and secondary efficacy endpoints (achievement
of
complete response and survival by day 100, respectively) had been collected
on
46 patients in the Defibrotide treatment arm and 86 patients in the historical
control group.
In
January, the Company previously announced the initiation of the DSMB’s interim
analysis. At that stage, the DSMB concluded that there were no safety concerns
and that the prospective treatment and historical control arms appeared to
be
well-balanced as to the stratification factors in the protocol. In order to
complete the interim analysis, the DSMB requested that the Company provide
supplemental trial data. The Company has since provided the DSMB with additional
information.
In
its
latest report, the DSMB reconfirmed its findings regarding safety and balance
of
the trial arms based on the data presented to date. However, the DSMB did have
concerns and questions about the data assembled and, accordingly, the DSMB
“did
not regard it proper to make a recommendation concerning the further conduct
of
the study at this time.” The DSMB did make one recommendation that the Company
obtains confirmation of “the criteria used to select historical controls and the
practical application of those criteria to guarantee that the historical
patients match the patients in the prospective study arm.” The Company is
evaluating the comments made by the DSMB and will respond
accordingly.
At
present, the Company has already enrolled more patients than required under
the
protocol, with 86 patients in the historical control group and 101 patients
in
the treatment arm, and does not anticipate enrolling further patients in the
trial.
“Due
to
the life threatening nature of severe VOD and the absence of any effective
alternative therapy, it was necessary to use a historical control arm in the
trial rather than a placebo control arm in order to meet ethical standards
and
attract the participation from key clinical transplant centers. Collecting
high
quality data from historical patient records is by its nature a challenging
process,” said Dr. Laura Ferro, Chairman and Chief Executive Officer of Gentium.
“We will continue treatment and follow up of the last patients enrolled in our
treatment arm and expect to have top-line data from this trial during Q4
2008.”
Gentium
will host a conference call today, June 5, 2008 at 5:00 p.m. (ET) to discuss
this press release and the other press release issued today by the Company
regarding clinical trial matters for Defibrotide.
Dial-in
Information:
US/Canada
Toll-Free callers: 877-407-8031
US/Canada
Toll or International Toll callers: 201-689-8031
Live
audio of the conference call will be simultaneously broadcast over the internet
via a webcast. To access the live webcast, log on to the Gentium's corporate
website at http://www.gentium.com.
A
replay
of the call also will be available until 11:59 PM US Eastern Time on June 12,
2008. To access the replay, dial 1-877-660-6853 from the US or Canada
(toll-free) or 1-201-612-7415 from other locations, and enter account #286
and
conference ID#287992. Additionally, an archived replay of the conference web
cast will be available on the Gentium website for 30 days.
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.”
Source:
Gentium
FOR
IMMEDIATE RELEASE
Company
Contact:
Gary
G.
Gemignani
Chief
Financial Officer
212-332-1666
ggemignani@gentium.com
Investor
Relations Contacts:
U.S.
The
Trout
Group
Laura
Okpala, 617-583-1306
lokpala@troutgroup.com
Marcy
Strickler, 646-378-2927
mstrickler@troutgroup.com
Italy:
Lifonti
& Company
Luca
Ricci Maccarini
luca.maccarini@lifonti.it
+39
027788871
Gentium
Announces Completion of Data Safety Monitoring Board Review and Continuation
of
the Phase II/III European Pediatric Prevention Trial of
Defibrotide
VILLA
GUARDIA (Como), Italy, June 5, 2008 (BUSINESS WIRE) -- Gentium S.p.A (NASDAQ:
GENT)
announced today that an independent Data Safety Monitoring Board (DSMB) has
completed the planned interim analysis for the Company's Phase II/III
multi-center, open label, randomized trial in Europe to evaluate prophylactic
use of Defibrotide in pediatric patients undergoing stem cell transplantation
at
high risk for hepatic veno-occlusive disease (VOD). The interim analysis was
performed subsequent to the enrollment of 240 patients.
The
DSMB
concluded that there are no significant safety concerns, the prophylactic
treatment arm (Defibrotide) and the control arm (no drug) are well balanced,
and
there is no evidence of clinical futility in the trial. Further, the DSMB
indicated that the results to date were satisfactory and recommended that the
trial continue to accrue patients. The DSMB also recommended increasing total
patient enrollment to 180 patients per arm from 135 patients per arm to achieve
a more statistically significant benefit of Defibrotide over the control. There
are no further planned interim analyses for this trial.
“The
DSMB’s recommendation is very encouraging and we await the final outcome of this
key trial with great interest,” said Dr. Dietger Niederwieser, Department of
Hematology and Oncology, University of Leipzig and President of the European
Group for Blood and Marrow Transplantation, the co-sponsor of the trial. “I am
hopeful that the results will be consistent with the promising data from earlier
published studies in prophylaxis and support the efficacy of Defibrotide in
preventing VOD.”
“We
are
pleased with the DSMB’s review and are following their recommendation to accrue
180 patients in each arm of the study,” said Dr. Laura Ferro, Chairman and Chief
Executive Officer of Gentium. “There are currently 276 patients enrolled in the
trial and we plan to complete enrollment around year-end and report
top-line results during the first half of 2009. We have also been advised
recently by EMEA that our planned filing in this indication could be eligible
for an accelerated review, which could reduce the review cycle from seven months
to five.”
Gentium
will host a conference call today, June 5, 2008 at 5:00 p.m. (ET) to discuss
this press release and the other press release issued today by the Company
regarding clinical trial matters for Defibrotide.
Dial-in
Information:
US/Canada
Toll-Free callers: 877-407-8031
US/Canada
Toll or International Toll callers: 201-689-8031
Live
audio of the conference call will be simultaneously broadcast over the internet
via a webcast. To access the live webcast, log on to the Gentium's corporate
website at http://www.gentium.com.
A
replay
of the call also will be available until 11:59 PM US Eastern Time on June 12,
2008. To access the replay, dial 1-877-660-6853 from the US or Canada
(toll-free) or 1-201-612-7415 from other locations, and enter account #286
and
conference ID#287992. Additionally, an archived replay of the conference web
cast will be available on the Gentium website for 30 days.
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.”
Source:
Gentium