Gamida Cell Announces Results from Phase 3 Study of Omidubicel to be Presented at the 47th Annual Meeting of the European Soc...
March 01 2021 - 7:00AM
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 results from the Phase 3
clinical trial of omidubicel will be presented in an oral session
at the Presidential Symposium of the 47th Annual Meeting of the
European Society for Blood and Marrow Transplantation (EBMT 2021),
which is being held virtually March 14–17, 2021.
Details about the presentation are as follows:
Time: Monday, March 15, 2021, at 3:24 p.m. CET (10:24
a.m. EST) Abstract Number: GS2-7 Title: Results of a
Phase III Randomized, Multicenter Study Comparing Omidubicel with
Standard Umbilical Cord Blood Transplantation (UCBT) in Patients
with High-Risk Hematologic Malignancies Following Myeloablation
Lead Author: Professor Guillermo F. Sanz, M.D., Ph.D.
The abstract will also be featured in a live panel discussion,
“EBMT Talks: Live with Best Abstracts,” on March 15 at 6:10 p.m.
CET (1:10 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), for which it has been granted
Breakthrough Status by the US Food and Drug Administration. 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.1,2 Based on the recently reported
Phase 3 clinical study, in which omidubicel achieved statistically
significant and clinical meaningful results in the prespecified
primary and secondary endpoints, Gamida Cell plans to submit the
full Biologics License Application (BLA) to the 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 the anticipated submission of a BLA
for omidubicel, which statements are subject to a number of risks,
uncertainties and assumptions, including, but not limited to Gamida
Cell’s ability to prepare regulatory filings and the review process
therefor; complications in Gamida Cell’s plans to manufacture its
products for commercial distribution; 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.
_________________ 1 Gamida Cell press release, “Gamida Cell
Announces Positive Topline Data from Phase 3 Clinical Study of
Omidubicel in Patients with High-Risk Hematologic Malignancies,”
issued May 12, 2020. Last accessed August 31, 2020. 2 Horwitz 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.
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For investors: Stephanie Ascher Stern Investor Relations,
Inc. stephanie.ascher@sternir.com 1-212-362-1200
For media: Rhiannon Jeselonis Ten Bridge Communications
rhiannon@tenbridgecommunications.com 1-978-417-1946
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