Gentium to Present at Angiogenesis in Cancer and Vascular Disease Congress; Defibrotide Has Anti-Angiogenic Properties In Vitro
02 Febrero 2006 - 7:00AM
Business Wire
Gentium S.p.A. (AMEX:GNT) (the "Company") today reported that on
February 7, 2006, Guenther Eisser, Chief of Biology Research for
Gentium, will present a poster entitled, "Defibrotide, an
endothelium stabilizing drug, has anti-angiogenic properties in
vitro and in vivo," at the Angiogenesis in Cancer and Vascular
Disease Congress being held in Miami, Fla. from February 4-8, 2006.
The anti-angiogenic potential of Defibrotide was tested in-vitro
using the sprouting of cells from the rat aortic ring in
Matrigel(TM) and a kit with human microvascular endothelial cells
forming vessel-like structures across a layer of dermal fibroblasts
(AngioKit(TM)). The in-vivo testing of Debrotide was performed in
mice injected with human gastric cancer. The results show that
daily application of Defibrotide almost quantitatively blocks
sprouting in the aortic ring assay at concentrations corresponding
to pharmacologic Defibrotide blood levels. Similarly, the second
in-vitro assay (AngioKit(TM)) demonstrates that Defibrotide reduces
vessel formation of human microvascular endothelial cells across a
barrier of dermal fibroblasts. In-vivo tumor angiogenesis in a
human gastric cancer grown in nude mice was attenuated on day 5 by
Defibrotide. Initial Western blotting results show that Defibrotide
reduces phosphorylation-activation of p70S6 kinase, which is a key
target in the P13K/Akt/mTOR signaling pathway linked to endothelial
cell and pericyte proliferation and activation. Dr. Eisser
concluded, "Our data suggest that while Defibrotide is known for
its endothelium-protecting function, it also inhibits tumor blood
vessel formation and thus should be considered for further testing
as an anti-cancer agent, either alone or in combination with other
drugs." Commenting on the presentation of this data, Dr. Laura
Ferro, chairman and chief executive officer of Gentium, stated, "We
are pleased to present the work of Dr. Eisser and his colleagues as
it expands our knowledge of Defibrotide's possible pharmacodynamic
actions, thereby elucidating the potential therapeutic benefits
that might be tested in a variety of cancer and vascular
indications. "These findings expand our understanding of the
possible utility of Defibrotide as an anti-tumor agent. Earlier
preclinical studies conducted at the Jerome Lipper Multiple Myeloma
Center at Harvard University's Dana Farber Cancer Institute which
were very promising and suggested that Defibrotide sensitizes
Multiple Myeloma (MM) cells to anti-MM agents in the bone marrow by
preventing the molecular cascade of events triggered by MM-bone
marrow stromal cells contact. This pre-clinical study provided the
framework for an independent, multi-center Phase I/II clinical
trial of Defibrotide in the treatment of Multiple Myeloma that is
currently underway in Italy." 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. Defibrotide to Treat Multiple Myeloma
Defibrotide is the subject of an independent Phase I/II study to
treat Multiple Myeloma (MM) in combination with Melphalan,
Prednisone, and Thalidomide (MPT) that is underway at ten centers
in Italy. This Phase I/II dose-escalating, multi-center,
non-comparative, open label study is designed to assess the safety
and the efficacy of Defibrotide with MPT regimen as a salvage
treatment in advanced refractory MM patients. The Company intends
to evaluate the results of this trial with its scientific advisors
to determine what its clinical development plans are for this
indication. 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 to 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)(5)
under the caption "Risk Factors."
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