Gamida Cell to Present Full Data from Phase 3 Study of Omidubicel at TCT, the Combined Transplantation and Cellular Therapy Meetings of ASTCT and CIBMTR https://finance.yahoo.com/news/gamida-cell-present-full-data-200000742.html
Mon, January 11, 2021, 10:00 PM GMT+2
Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious hematologic diseases, today announced that the full results of the Phase 3 clinical trial of omidubicel will be presented for the first time at the TCT Meetings, the Transplantation & Cellular Therapy Meetings of the American Society of Transplantation and Cellular Therapy (ASTCT) and Center for International Blood & Marrow Transplant Research (CIBMTR), which is being held virtually from February 8–12, 2021.
The international, multi-center, randomized Phase 3 study for omidubicel evaluated the safety and efficacy of omidubicel in patients with hematologic malignancies undergoing allogeneic bone marrow transplant compared to a comparator group of patients who received a standard umbilical cord blood transplant.
This will be the first presentation of the full efficacy and safety results of this study. Gamida Cell previously reported in 2020 top-line data for omidubicel, an advanced cell therapy under development as a potentially life-saving allogeneic hematopoietic stem cell transplant solution for patients with hematologic malignancies. Last May, Gamida Cell reported that the study achieved its primary endpoint, demonstrating a highly statistically significant reduction in time to neutrophil engraftment, a key milestone in a patient’s recovery from a bone marrow transplant. Last October, the company reported that the omidubicel phase 3 study achieved its secondary endpoints of platelet engraftment, infections, and hospitalizations.
Details about the presentation are as follows:
Title: Improved Clinical Outcomes with Omidubicel Versus Standard Myeloablative Umbilical Cord Blood Transplantation: Results of a Phase III Randomized, Multicenter Study
Lead Author: Mitchell E. Horwitz, M.D. Time: Tuesday, February 9, 2021, 4:45-5:00 p.m. EST