Gamida Cell to Present Full Data from Phase 3 Study of Omidubicel at TCT, the Combined Transplantation & Cellular Therapy Mee...
January 11 2021 - 3:00PM
Business Wire
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
About Omidubicel
Omidubicel 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). In both Phase 1/2 and Phase 3
clinical studies (NCT01816230, NCT02730299), omidubicel
demonstrated rapid and durable time to engraftment and was
generally well tolerated. The company expects to submit a full
biologics licensing application to the U.S. FDA in the second half
of 2021. Omidubicel is also being evaluated in a Phase 1/2 clinical
study in patients with severe aplastic anemia (NCT03173937). The
aplastic anemia investigational new drug application is currently
filed with the FDA under the brand name CordIn®, which is the same
investigational development candidate as omidubicel. For more
information on clinical trials of omidubicel, please visit
www.clinicaltrials.gov.
Omidubicel is an investigational therapy, and its safety and
efficacy have not been established by the U.S. Food and Drug
Administration or any other health authority.
About Gamida Cell
Gamida Cell is an advanced cell therapy company committed to
cures for patients with blood cancers and serious blood diseases.
We harness our cell expansion platform to create therapies with the
potential to redefine standards of care in areas of serious medical
need. For additional information, please visit www.gamida-cell.com
or follow Gamida Cell on LinkedIn or Twitter at @GamidaCellTx.
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 timing of initiation and progress
of and data reported from the clinical trials of Gamida Cell’s
product candidates, anticipated regulatory filings, launch
readiness and FDA approval, commercialization efforts and Gamida
Cell’s expectations regarding its projected ongoing operating
activities, which statements are subject to a number of risks,
uncertainties and assumptions, including, but not limited to the
scope, progress and expansion of Gamida Cell’s clinical trials and
ramifications for the cost thereof; and clinical, scientific,
regulatory and technical developments. In light of these risks and
uncertainties, and other risks and uncertainties that are described
in the Risk Factors section and other sections of Gamida Cell’s
Annual Report on Form 20-F, filed with the Securities and Exchange
Commission (SEC) on February 26, 2020 and its Report on Form 6-K
furnished to the SEC on August 12, 2020, and other filings that
Gamida Cell makes with the SEC from time to time (which are
available at http://www.sec.gov), the events and circumstances
discussed in such forward-looking statements may not occur, and
Gamida Cell’s actual results could differ materially and adversely
from those anticipated or implied thereby. Any forward-looking
statements speak only as of the date of this press release and are
based on information available to Gamida Cell as of the date of
this release.
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version on businesswire.com: https://www.businesswire.com/news/home/20210111005371/en/
For investors: Stephanie Ascher Stern Investor Relations,
Inc. stephanie.ascher@sternir.com 1-212-362-1200
For media: Matthew Corcoran Ten Bridge Communications
mcorcoran@tenbridgecommunications.com 1-617-866-7350
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