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 March, 2006.
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-_______________.
Description
of events affecting the Registrant are set forth in the Registrant's press
release, dated March 28, 2006, attached hereto as Exhibit Number 1 and
incorporated by reference herein in its entirety.
Exhibit Description
1 Press
release, dated March 28, 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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By: |
/s/
Cary
Grossman
|
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Name: Cary
Grossman |
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Title:
Executive Vice President and Chief Financial
Officer
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Date:
March
28,
2006
INDEX
TO EXHIBITS
Exhibit Description
1 Press
release, dated March 28, 2006.
Exhibit
1
PRESS
RELEASE
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
RECEIVES FIRST IRB APPROVALTO BEGIN U.S. PHASE III
TRIAL WITH DEFIBROTIDE TO
TREAT VENO-OCCLUSIVE DISEASE
WITH MULTIPLE-ORGAN FAILURE
Dana-Farber/Harvard
Cancer Center, Massachusetts General Hospital, Beth Israel
Deaconess Medical
Center and The Children’s Hospital Receive IRB Approval to Commence
Study
Villa
Guardia (Como), Italy (March 28, 2006) - Gentium S.p.A. (AMEX: GNT)
(the
Company) has received its first Institutional Review Board (IRB) approvals
to
initiate a U.S. Phase III clinical trial with Defibrotide for the treatment
of
Veno-Occlusive Disease (VOD) with Multiple Organ Failure (Severe VOD) as a
complication of stem cell transplantation (SCT). Data from this 80-patient,
multi-center trial will be compared to an historical control group of 80
patients, with survival at day 100 as the primary endpoint. The Company believes
that approximately 80% of patients with Severe VOD die within 100 days of SCT
without treatment. The Company believes that there are no approved treatments
for Severe VOD.
The
IRB
of the Dana-Farber/Harvard Cancer Center of Boston, Mass., which is also the
IRB
for Dana-Farber Cancer Institute, Massachusetts General Hospital, Beth Israel
Deaconess Medical Center and The Children’s Hospital, is the first to give its
approval to commence the study. All four of these institutions are expected
to
participate in the trial. Work to compile historical control data will begin
immediately, and the first patients are expected to be treated by early
May,
2006.
The
multi-center trial will be conducted at approximately 20 U.S. cancer centers
pending the IRB approval at each institution. In addition to the institutions
mentioned above, the Company expects the trial to include M.D. Anderson Cancer
Center, Fred Hutchinson Cancer Research Center, Memorial Sloan-Kettering Cancer
Center, Johns Hopkins Hospital and Health System, Duke University Hospital,
City
of Hope Cancer Center, The Children’s Hospital of Philadelphia, University of
Minnesota Medical Center and The St. Jude Children’s Research Hospital, among
others.
Paul
Richardson, M.D., Clinical Director of Dana-Farber Cancer Institute’s Jerome
Lipper Multiple Myeloma Center and Assistant Professor of Medicine at Harvard
Medical School, is the principal investigator of this Phase III trial. He
recently
presented Phase II data of Defibrotide as a treatment for Severe VOD at the
2005
American Society of Hematology (ASH) Annual Scientific Meeting. Commenting
on
the140-patient,
multi-center, randomized, dose-finding Phase II study, Dr. Richardson said,
“Treatment of Severe VOD with Defibrotide resulted in a survival rate at 100
days post SCT of approximately 40%, which compares favorably with the 100-day
survival rate of approximately 20% or less reported in published studies of
Severe VOD. These results are encouraging, with response and long-term survival
seen even in patients who either were on dialysis or were ventilator-dependent
at the start of Defibrotide therapy. In addition, the side effect profile of
Defibrotide was favorable in this extremely sick patient
population.”
“As
we
continue to advance the development of Defibrotide, we are increasingly
impressed by the consistency of the clinical findings and I am optimistic that
we will soon be able to offer an effective treatment option for patients
suffering from this otherwise often fatal disease,” commented Laura Ferro, M.D.,
president and chief executive officer of Gentium. “We are pleased to initiate
this U.S. Phase III study and hope to see compelling clinical
results.”
The
U.S.
Food and Drug Administration (FDA) has granted Defibrotide Orphan Drug Status
and Fast Track designation for the treatment of Severe VOD. In addition,
previous clinical trials with Defibrotide for the treatment of Severe VOD have
been supported by grants from FDA’s Office of Orphan Products Development.
About
VOD
VOD
is a
potentially life-threatening condition. 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
that
can lead to liver failure and the failure of other organs (Severe VOD). SCT
is a
frequently used treatment following high dose chemotherapy and radiation
therapy. The International Bone Marrow Transplant Registry estimated that
approximately 45,000 people received blood and bone marrow transplants, which
are types of SCT, in 2002. Based on the Company’s review of more than 200
published papers, it believes that 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. The Company believes that there are
no
approved therapies to treat or prevent VOD in the U.S or the EU.
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)(5) under the caption “Risk Factors.”
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