Kiadis Pharma receives two orphan drug designations for Reviroc
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Kiadis Pharma has announced that the U.S. Food and Drug Administration (FDA) has granted its product Reviroc Orphan Drug Designations (ODD) for the treatment of two types of Non-Hodgkin Lymphoma (NHL).
One ODD has been granted for diffuse large B-cell lymphoma and the other one for the treatment of follicular lymphoma. Reviroc(TM) is under development for the elimination of cancer cells from an autologous graft in bone marrow transplantations for end-stage blood cancer patients.
“This is an important strategic milestone in the development of Reviroc(TM) and we are very pleased with the orphan drug designations received from the FDA,” says Dr. Manja Bouman, Chief Executive Officer of Kiadis Pharma.
The FDA’s orphan drug designation is reserved for new therapies being developed to treat diseases or conditions that affect fewer than 200,000 people in the United States. The orphan drug designation provides for an accelerated review process, tax benefits, exemption from user fees and a seven-year period of market exclusivity in the US after product approval.
Reviroc(TM) is being developed as a treatment that eliminates blood cancer cells from autologous transplants for patients with end stage blood cancer. An autologous transplant uses the patient’s own bone marrow to serve as a graft. Bone marrow transplants are broadly recognized as a treatment option for patients suffering from blood cancers, such as leukemia and lymphoma. One of the limitations of autologous bone marrow transplantations is the high relapse rate associated with this treatment. This is often caused by the presence of cancer cells in the transplant. Reviroc(TM) has been developed to remove tumor cells from the graft.
Biopharmaceutical company Kiadis Pharma announces that it has successfully completed treatment of the last patient on its ATIR phase I/II clinical trial. ATIR, a donor lymphocyte cell based product, is under development to prevent acute Graft versus Host Disease (GvHD) and allow early immune reconstitution following a mismatched bone marrow transplantation. Nineteen end stage
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A unique approach to bone marrow transplantation pioneered in part by a Children’s Hospital of Pittsburgh of UPMC physician has proven to be the only safe and effective cure for sickle cell disease, according to a new study. Lakshmanan Krishnamurti, MD, a pediatric hematologist/oncologist at Children’s Hospital, helped pioneer a form of bone marrow transplantation
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Reata Pharmaceuticals, Inc. has announced that RTA 402 has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer. RTA 402 is currently being studied in a Phase 1/2 trial in patients with pancreatic cancer, and is also in Phase 2 development for chronic kidney disease.
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The U.S. Food and Drug Administration has approved Mozobil (plerixafor), a drug that helps increase the number of blood stem cells for bone marrow transplantation in patients with certain forms of blood cancer. Mozobil is intended to be used in combination with the growth factor granulocyte-colony stimulating factor (G-CSF), for treatment of adults with multiple
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Two studies examining the effects of stem cell source and patient age on stem cell transplantation outcomes were explored at a press conference on Sunday, December 7 during the 50th Annual Meeting of the American Society of Hematology in San Francisco, CA. Preliminary results from a study examining a specialized technique for increasing the presence
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