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, 2006.
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
x
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 x
If
“Yes”
is marked, indicate below the file number assigned to the registrant in
connection with Rule 12g3-2(b):
82-_______________.
Descriptions
of events affecting the Registrant are set forth in the Registrant's press
releases, dated January 20, 2006 and January 30, 2006, attached hereto as
Exhibits Number 1 and Number 2, respectively, both of which are incorporated
by
reference herein in their entirety.
Exhibit Description
1 Press
release, dated January 20, 2006.
2 Press
release, dated January 30, 2006.
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: January
30,
2006 |
By: |
/s/ Cary
Grossman |
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Cary
Grossman |
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Executive
Vice President and Chief Financial
Officer
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INDEX
TO EXHIBITS
Exhibit Description
1 Press
release, dated January 20, 2006.
2 Press
release, dated January 30, 2006.
Exhibit
1
FOR
IMMEDIATE RELEASE
Company
Contact:
Cary
Grossman
Chief
Financial Officer
713-827-2104
cgrossman@gentium.it
Investor
Relations Contacts:
U.S.
Lippert/Heilshorn
& Assoc.
Kim
Sutton Golodetz
Kgolodetz@lhai.com
Anne
Marie Fields
afields@lhai.com
212-838-3777
Italy:
Burson-Marsteller
Luca
Ricci Maccarini
luca_maccarini@it.bm.com
+39
02.721431
GENTIUM
INITIATES PHASE II/III PEDIATRIC TRIAL WITH
DEFIBROTIDE
TO PREVENT VENO-OCCLUSIVE DISEASE
European
Group for Blood and Marrow Transplantation to Co-Sponsor Study at
30
European and Israeli Clinical Sites
Villa
Guardia (Como), Italy (January 20, 2006) - Gentium S.p.A. (AMEX: GNT)
(the
“Company”) today announced the initiation of a Phase II/III trial with
Defibrotide to prevent Veno-Occlusive Disease (“VOD”), a complication of bone
marrow and stem cell transplantation (SCT), in pediatric patients. The
randomized study will include 270 pediatric patients undergoing SCT at 30
clinical sites in Europe and Israel and will evaluate the ability of Defibrotide
to prevent VOD. Secondary endpoints are measuring the severity of VOD and the
occurrence of transplant-associated microangiopathy in each group. The European
Group for Blood and Marrow Transplantation (EBMT) is co-sponsoring the study
with additional support from the Deutsche Krebshilfe (German Cancer Aid). The
principal investigator is Selim Corbacioglu, M.D., Dept of Pediatrics -
University of Ulm, Germany.
Certain
chemotherapy and radiation therapies such as those used in stem cell
transplantation can damage cells of the blood vessels and produce VOD, a
blockage of the small veins of the liver which leads to damage of the liver
cells. Approximately 20% of patients who undergo SCT develop VOD and
approximately one-third of these patients progress to multiple organ failure
(Severe VOD). Nearly 80% of Severe VOD patients die within three months. There
are currently no approved therapies to treat or prevention VOD.
Laura
Ferro, M.D., president and chief executive officer of Gentium, said, “Preventing
VOD in stem cell transplant patients is critically important, especially for
pediatric patients who are particularly susceptible to developing VOD due to
the
nature of their treatment regimen. We look forward to also beginning our
European trial for the prevention of VOD and transplant-associated
microangiopathy in adults in the second quarter of this year.”
“Earlier
clinical trials of Defibrotide to treat and prevent VOD have shown encouraging
results. We are pleased to begin this prevention trial in children and hope
it
will provide evidence of Defibrotide’s potential efficacy to prevent VOD. “
“We
are
delighted that the EBMT and the Deutsche Krebshilfe have agreed to support
our
efforts to develop a preventative drug for patients at risk of developing VOD,
a
potentially fatal disease, for which there are no currently approved therapies,”
concluded Dr. Ferro.
Defibrotide
is a single-stranded DNA that protects the vascular endothelial cells,
particularly those of small vessels, from damage and activation. After binding
to endothelial cells, Defibrotide decreases cell adhesion and pro-coagulant
activity of activated endothelial cells, and increases the fibrinolytic
potential of endothelial cells. Defibrotide’s effects are predominately local
within the vascular bed, and there is no significant effect on systemic
coagulation. Its beneficial pharmacological effects are due to its
anti-thrombotic, anti-inflammatory and anti-ischemic properties.
Defibrotide
is expected to be the subject of a U.S. Phase III study as a treatment for
Severe VOD in the coming weeks. The Company also intends to initiate studies
of
Defibrotide to prevent VOD in the U.S. by early 2007.
About
VOD
VOD
is a
potentially life-threatening condition. The International Bone Marrow Transplant
Registry estimated that approximately 45,000 people received blood and bone
marrow transplants in 2002. Based on the Company’s review of more than 200
published papers it is estimated that up to 20% of patients who receive blood
and bone marrow transplants contract VOD. When Severe VOD occurs, blood vessels
in the liver become blocked, liver failure follows and kidneys cease to function
as a result of the toxic effects of cancer treatments such as high dose
chemotherapy and radiation, used during SCT. Approximately 80% of patients
who
contract Severe VOD die within 100 days of SCT without treatment. VOD is
considered one of the most important and challenging complications of SCT.
There
currently are no approved therapies to treat or prevent VOD.
About
Gentium
Gentium
S.p.A. is a biopharmaceutical company located in Villa Guardia (Como), Italy
that is 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
in the U.S., is an investigational drug that has been granted Orphan Drug status
by the U.S. FDA to treat Severe VOD and Fast Track designation 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 Prospectus filed with the Securities and Exchange Commission under Rule
424(b)(4) under the caption “Risk Factors.”
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Exhibit
2
FOR
IMMEDIATE RELEASE
Company
Contact:
Cary
Grossman
Chief
Financial Officer
713-827-2104
cgrossman@gentium.it
Investor
Relations Contacts:
U.S.
Lippert/Heilshorn
& Assoc.
Kim
Sutton Golodetz
Kgolodetz@lhai.com
Anne
Marie Fields
afields@lhai.com
212-838-3777
Italy:
Burson-Marsteller
Luca
Ricci Maccarini
luca_maccarini@it.bm.com
+39
02.721431
GENTIUM’S
DEFIBROTIDE SUBJECT OF INDEPENDENT
STUDY
IN
JAPAN
First
Japanese Study Reports That Defibrotide Shows Success Treating Severe
Veno-Occlusive
Disease
Villa
Guardia (Como), Italy (January 30, 2006) - Gentium S.p.A. (AMEX: GNT)
(the
“Company”) today reported that an independent study of Defibrotide was the
subject of a published paper entitled, “Successful
Treatment with Defibrotide for Sinusoidal Obstruction Syndrome (also
known as Veno-Occlusive Disease or “VOD”) after
Hematopoietic Stem Cell Transplantation (SCT),”
which
appeared in the December 2005 issue of Kobe Journal
of Medical Science.
The
lead author of the paper was Kimikazu Yakushijin, Division of
Endocrinology/Metabolism, Neurology and Hematology/Oncology, Department of
Clinical Molecular Medicine, Kobe University Graduate School of Medicine, Japan.
Certain
high dose chemotherapy and radiation therapies and stem cell transplantation
(SCT) can damage cells of the blood vessels and result in VOD, a blockage of
the
small veins of the liver which can lead to liver failure and the failure of
the
kidneys and other organs. SCT is a frequently used treatment following high
dose
chemotherapy and radiation therapy. Based on the Company’s review of more than
200 published papers, approximately 20% of patients who undergo SCT develop
VOD,
approximately one-third of those who develop VOD progress to multiple organ
failure (Severe VOD), and approximately 80% of Severe VOD patients die within
100 days of the SCT. There
are
currently no approved therapies to treat or prevent VOD in the U.S. or the
E.U.
According
to the published study, all patients showed evidence of multiple organ failure
at the start of treatment, four patients were treated with Defibrotide for
14 to
27 days, three patients (75%) responded to the therapy, two patients survived
at
100 days post SCT (50%), and none of the patients suffered from significant
adverse effects.
The
paper
concluded that this is the first report dealing with the use of of Defibrotide
to treat Japanese patients with VOD and because Defibrotide is considered to
be
promising for the treatment of VOD, it is important that further studies be
initiated as soon as possible in Japan.
Commenting
on the publication, Dr. Laura Ferro, chairman and chief executive officer of
Gentium, stated, “We were pleased with Dr. Yakushijin’s independent study as it
builds on our body of clinical evidence that supports the use of Defibrotide
to
treat Severe VOD. Data from Harvard University’s Dana Farber Cancer Institute’s
U.S. Phase II study showed an increase in survival rate at 100 days post SCT
of
approximately 39%, compared with the historical 100-day survival rate of
approximately 20%.“
Defibrotide
to Treat Severe VOD
The
Company is awaiting Institutional Review Board approval for its pivotal U.S.
Phase III trial of Defibrotide to treat Severe VOD and expects to initiate
that
trial in the coming weeks.
Defibrotide
to Prevent VOD
The
Company recently initiated a Phase II/III trial with Defibrotide to prevent
VOD
in pediatric patients. The randomized study will include 270 pediatric patients
undergoing SCT at 30 clinical sites in Europe and Israel and will evaluate
the
ability of Defibrotide to prevent VOD.
The
Company plans to initiate a Phase II/III trial with Defibrotide to prevent
VOD
in adult patients in Europe during the second quarter of 2006 and in the U.S.
by
early 2007.
About
Defibrotide
Defibrotide
is a single-stranded DNA that protects the vascular endothelial cells,
particularly those of small vessels, from damage and activation. After binding
to endothelial cells, Defibrotide decreases cell adhesion and pro-coagulant
activity of activated endothelial cells, and increases the fibrinolytic
potential of endothelial cells. Defibrotide’s effects are predominately local
within the vascular bed, and there is no significant effect on systemic
coagulation. Its beneficial pharmacological effects are due to its
anti-thrombotic, anti-inflammatory and anti-ischemic properties.
About
VOD
VOD
is a
potentially life-threatening condition. The International Bone Marrow Transplant
Registry estimated that approximately 45,000 people received blood and bone
marrow transplants in 2002. Certain high dose chemotherapy and radiation
therapies and stem cell transplantation (SCT) can damage cells of the blood
vessels and result in VOD, a blockage of the small veins of the liver which
can
lead liver failure and the failure of other organs (Severe VOD). SCT is a
frequently used treatment following high dose chemotherapy and radiation
therapy. Based on the Company’s review of more than 200 published papers, it is
estimated that approximately 20% of patients who receive SCT contract VOD.
Approximately 80% of patients who contract Severe VOD die within 100 days of
SCT. VOD is considered one of the most important and challenging complications
of SCT. There currently are no approved therapies to treat or prevent VOD in
the
U.S or the E.U.
About
Gentium
Gentium
S.p.A. is a biopharmaceutical company located in Villa Guardia (Como), Italy
that is 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
in the U.S., is an investigational drug that has been granted Orphan Drug status
by the U.S. FDA to treat VOD, Fast Track designation by the U.S. FDA for the
treatment of Severe VOD in recipients of stem cell transplants, and Orphan
Drug
designation by European Union regulators to treat and 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 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 Prospectus filed with the Securities and Exchange Commission under Rule
424(b)(4) under the caption “Risk Factors.”
#
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