Gentium S.p.A. Announces Initiation of Independent Phase I/II Study of Defibrotide to treat Multiple Myeloma
21 September 2005 - 8:00PM
Business Wire
Gentium S.p.A. (AMEX:GNT) (the "Company") announced today that its
lead product, Defibrotide, will be the subject of an independent
Phase I/II study to treat Multiple Myeloma (MM) in combination with
Melphalan, Prednisone, and Thalidomide (MPT) at approximately 10
cancer centers in Italy. The principal investigator for this study
is Dr. Mario Boccadoro, M.D., Division of Hematology, University of
Turin, Italy. The study is a Phase I/II dose-escalating,
multi-center, non-comparative, open label study designed to assess
the safety and the efficacy of Defibrotide with MPT regimen as a
salvage treatment in advanced refractory MM patients. The Phase I
component of the study will combine oral MPT with escalating doses
of Defibrotide to determine the maximum tolerated dosage (MTD) of
Defibrotide combined with MPT in 24 patients (three cohorts of
eight patients). In the Phase II component of the study, the oral
MPT regimen will be combined with the MTD of Defibrotide and
administered to 20 consecutive patients to assess response rate and
clinical efficacy. Dr. Laura Ferro, Chairman and Chief Executive
Officer of the Company, said, "We are encouraged by the continued
interest from world leading clinicians to independently test
Defibrotide to treat Multiple Myeloma. Preclinical studies
conducted at the Jerome Lipper Multiple Myeloma Center at Harvard
University's Dana Farber Cancer Institute were very promising and
suggest that Defibrotide sensitizes 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 this Phase I/II
clinical trial of oral MPT in combination with Defibrotide in the
treatment of Multiple Myeloma." "Independent studies such as this
one offer Gentium the opportunity to advance our clinical pipeline
in important indications like Multiple Myeloma," Dr. Ferro added.
About Multiple Myeloma Multiple Myeloma is a cancer of the plasma
cell. The American Cancer Society estimates that about 15,980 new
cases of Multiple Myeloma will be diagnosed in the U.S. during
2005. Approximately 11,300 Americans are expected to die of
Multiple Myeloma in 2005. The 5-year survival rate for patients
with Multiple Myeloma is approximately 32%. 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 extensive beneficial pharmacological
effects owe to its anti-thrombotic, anti-inflammatory and
anti-ischemic properties. Defibrotide is the subject of U.S. Phase
III study that is about to begin as a treatment for veno-occlusive
disease with multiple organ failure (Severe VOD), and in EU Phase
II/III studies for the prevention of VOD. Defibrotide has been on
the market in Italy since 1986, initially as a treatment for deep
vein thrombosis and currently as a preventive for vascular disease
with risk of thrombosis. About the Company The Company, located in
Como, Italy, is a biopharmaceutical company focused on the
research, discovery and development of drugs derived from DNA
extracted from natural sources and drugs which are synthetic
derivatives (molecules chemically similar to natural DNA) to treat
and prevent a variety of vascular diseases and conditions related
to cancer and cancer treatments. 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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