Gamida Cell and the CIBMTR Announce Collaboration to Advance Research for Life-Saving Cellular Therapy
– Multi-Year Observational Study Designed to Evaluate Outcomes of Patients with Hematologic Malignancies Who Undergo Allogeneic Bone Marrow Transplantation –
The newly launched observational study by the CIBMTR and
“We are pleased to announce this collaboration with
“This agreement marks the beginning of Gamida Cell’s health outcomes research initiatives, and we are excited to partner with the CIBMTR, an organization with deep expertise in bone marrow transplantation and cellular therapy,” stated
Randomized clinical trials comparing different donor types suggest that clinical outcomes may vary significantly depending on the donor type. The goal of this real-world, observational study is to better understand the variables that influence the health outcomes of patients receiving a transplant from a source other than a fully matched family donor. As part of the research agreement, the CIBMTR will use its registry, which consists of clinical outcomes data on more than 500,000 stem cell transplants, to analyze long‐term safety and efficacy data for patients with hematologic malignancies who underwent a bone marrow transplant with an alternative donor source following myeloablative conditioning. The criteria for inclusion of patients and the endpoints evaluated in the analysis will be consistent with the design of the Phase 3 study of omidubicel.
About Omidubicel
Omidubicel (formerly known as NiCord®), the company’s lead clinical program, is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies (blood cancers). Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the
Omidubicel is an investigational therapy, and its safety and efficacy has not been evaluated by the
About
About CIBMTR
The CIBMTR® (
solutions for cell and gene therapy developers, including cell sourcing and collection, clinical trial services, supply chain and logistics, manufacturing and commercialization support, and outcomes management. The CIBMTR collaborates with the global scientific community to advance hematopoietic cell transplantation (HCT) and cellular therapy worldwide to increase survival and enrich quality of life for patients. The CIBMTR facilitates critical observational and interventional research through scientific and statistical expertise, a large network of transplant centers, and a unique and extensive clinical outcomes database.
Cautionary Note Regarding Forward Looking Statements
This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including with respect to Gamida Cell’s collaboration with the CIBMTR and Gamida Cell’s Phase 3 study, which statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to the timing and outcome of such collaboration and Phase 3 study. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section of Gamida Cell’s public filing on Form 20-F, filed with the
References
1Horwitz M.E., Wease S., Blackwell B., Valcarcel D. et al. Phase I/II study of stem-cell transplantation using a single cord blood unit expanded ex vivo with nicotinamide. J Clin Oncol. 2019 Feb 10;37(5):367-374.
2ClinicalTrials.gov identifier NCT02730299.
3ClinicalTrials.gov identifier NCT03173937.
4ClinicalTrials.gov identifier NCT03019666.
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Source:
Gamida Cell Contacts:
Jaren Irene Madden
jaren@gamida-cell.com
617-892-9084
Krystle Gibbs (media)
krystle@tenbridgecommunications.com
508-479-6358
CIBMTR Contact:
Liz Siepmann
Communications Specialist
esiepmann@mcw.edu
(414) 805-0665