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New Phase I Study Announcement Of Interleukin-7 As Immunotherapy In Treatment Of Bone Marrow Or Peripheral Blood Stem Cell Transplant Patients

November 13th, 2008 · No Comments
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Cytheris SA, a clinical chapter biopharmaceutical people granted by research and step up of different analysis in bracket of immune modulation, today announced the introduction of a Phase I clinical examination of its head investigational tablets claimant, Interleukin-7 (IL-7), also specified close vehicle of CYT107. This new trial will exploration the use up of IL-7 / CYT107 contained by the behaviour of post-transplant patients with T-cell depleted wipe down marrow or lateral blood vine cell transplant. The pilot study station will be at Memorial Sloan-Kettering Cancer Center (MSKCC) in New York City, where on earth Marcel R.M. van den Brink, M.D., Ph.D., Head, Division of Hematologic Oncology, and Miguel-Angel Perales, M.D., Assistant Attending Physician in the Bone Marrow Transplant Service, will ladle as Principal Investigator and co-Principal Investigator, respectively. Additional study site be looked-for to spread out in the United States during the coming months.

Recombinant human Interleukin-7 (r-hIL-7) be a stern disease factor for immune T-cell retrieval and upturn. Clinical trial conduct on greater than 75 patients in Europe, the United States and Canada clutch suggested the almost of r-hIL-7 to extend and safeguard CD4+ and CD8+ T-cells. Cytheris is well-matched instantly conduct multiple global clinical study of IL-7 in HIV, HCV and cancer.

“We allotment a commitment with MSKCC to address the unmet medical necessitate that exist for cancer patients who are commonly in a profoundly immunodeficient feel at one with behind the bone marrow transplant set of rules, departing them in danger to a verdict of bacterial, viral, and fungal infection,” said Michel Morre, DVM, President and CEO of Cytheris. “MSKCC have for bounteous years be in the font of stem cell transplantation therapy in the U.S. and we are consequently thoroughly over and done with the moon that Drs van den Brink and Perales have agreed to romp a part of the pack here study which we optimism will ultimately lead to the development of therapies to avert post-transplant infections which so commonly sliver in to the flop of hematopoietic stem cell allografts.” About the Study Delayed and not good ample reconstitution of T-cell populations and their tough grind constitute a crucial stumbling block to the glory of a hematopoietic stem cell allograft. Experimental studies give you an notion about that IL-7 can wheeze recovery of thymopoiesis, peripheral lymphoid populations and their functions in murine addressee of allogeneic hematopoietic stem cell transplantation (HSCT) in need huddle Graft versus Host Disease (GVHD). Patients admit to the study must have histologically confirmed non-lymphoid hematological malignancy such as acute myeloid leukemia (AML), incorrigible myelogenous leukemia (CML), myelodysplastic syndrome (MDS), a precedent of an opportunistic pollution (including but not constrained to CMV viremia require anti-viral therapy), PCP pneumonia, mycobacterial infection, herpes zoster, or viral respiratory infection (influenza, RSV, para-influenza), and have a CD4+ T-cell put a figure on < 100 at 2 months post-transplant.

The foremost target of the exploration is to learn the safekeeping and a recommended dose of CYT107 in recipients of an HLA-matched connected or unrelated ex vivo T-cell-depleted bone marrow or peripheral blood stem cell transplant after initial engraftment and hematopoietic reconstitution. If toxicities are encounter, the study will also hope to initiate the maximum tolerate dose (MTD) and dose limiting toxicities (DLT).

About Cytheris Cytheris SA is a privately held clinical-stage biopharmaceutical company focused on research and development of new therapies for immune modulation. These drugs aim at reconstituting and enhancing the immune set of communications of patients misery from cancer, chronic viral or bacterial infections such as HIV and HCV, or lympho-depleting treatment such as chemotherapy, radiotherapy, bone marrow transplantation (BMT) and hematopoietic cell transplantation (HCT).

The company’s lead merged, recombinant human Interleukin-7 (r-hIL-7), is a critical growth factor for immune T-cell recovery and enhancement. Clinical trials conducted on more than 75 patients in Europe and North America have suggested the potential of r-hIL-7 to expand and protect CD4+ and CD8+ T-cells. The Company is currently conducting multiple clinical studies of IL-7 in HIV, HCV and cancer.

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