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Gentium to Present Data Showing Defibrotide Modulates Immune Functions

Posted on: Tuesday, 5 September 2006, 09:00 CDT

Gentium S.p.A. (NASDAQ:GENT) (the Company) today announced that Gunther Eissner, Ph.D., Department of Hematology, Regensburg University Medical Center, Regensburg, Germany, and Massimo Iacobelli, M.D., Senior Vice President, Scientific Director, Gentium, S.p.A., will make an oral presentation entitled, "Defibrotide Modulates Immune Functions Of Endothelial Cells - Impact For Transplantation And Cancer Therapy," at the 16th European Congress of Immunology. The Congress is being held from September 6-9, 2006 in Paris, France. The presentation will take place on Thursday afternoon, September 7, 2006 in the Immune Interventions Workshop--Immunohematology Track D section in Room 251 at 3:00 p.m. local time.

In their presentation, Drs. Eissner and Iacobelli will show evidence that Defibrotide can protect endothelial cells from conditioning-mediated apoptosis, which suggests that the drug may be used as a prophylactic in patients at risk for endothelial complications. The evidence demonstrates that Defibrotide has anti-inflammatory activity because it prevents transendothelial migration of immune effector cells, and it can reduce the chemotherapy-induced antigenicity of endothelial cells towards allogeneic cytotoxic T lymphocytes.

In addition to these endothelium stabilizing functions, recent pre-clinical evidence suggests that Defibrotide has anti-neoplastic properties, which may be due to its ability to prevent tumor angiogenesis. The anti-angiogenic potential of Defibrotide was tested in vitro using a novel angiogenesis kit (AngioKit(TM)) and in vivo using the dorsal skin fold chamber model in mice. The results demonstrated that Defibrotide at concentrations corresponding to pharmacologic Defibrotide blood levels (100 ug/mL) reduces blood vessel formation significantly (p=0.022), when administered on a daily basis. Furthermore, Defibrotide significantly reduced tumor angiogenesis in the murine dorsal skin fold chamber after inoculation of cells from the human gastric cancer TMK. Regarding the mechanism of action of Defibrotide, initial Western blotting results show that Defibrotide reduces phosphorylation-activation of p70S6 kinase, which is a key target in the PI3K/Akt/mTOR signaling pathway linked to angiogenesis. Additional in vitro data suggest that Defibrotide's action is independent of a blockade of vascular endothelial growth factor (VEGF).

Dr. Laura Ferro, Chairman and Chief Executive Officer of Gentium, commented on the presentation, "The pre-clinical data demonstrate Defibrotide's activity in multiple pathways. Taken together, the data suggest that while Defibrotide is known for its endothelium-protecting function, it also can inhibit blood vessel formation. These data support our clinical strategy to pursue further testing of Defibrotide as an anticancer agent, either as a monotherapy or in combination with other drugs, especially as it appears that it can work synergistically with other VEGF-dependent, anti-angiogenic substances."

About VOD

Veno-occlusive disease (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 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 Form 20F filed with the Securities and Exchange Commission under the caption "Risk Factors."

Source: Business Wire

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