GlycoMimetics Announces NCI-Sponsored Pivotal Trial of GMI-1271 in Older, Newly Diagnosed AML Patients Fit for Intensive Ch...
May 30 2018 - 9:15AM
Business Wire
- Third of three planned trials positions
GlycoMimetics to address unmet needs across the AML spectrum
GlycoMimetics, Inc. (NASDAQ: GLYC), a biopharmaceutical company
focused on discovering and developing novel small-molecule drug
candidates to treat rare diseases, announced today it had signed a
Cooperative Research and Development Agreement (CRADA) with the
National Cancer Institute (NCI), part of the National Institutes of
Health (NIH). Under the terms of the CRADA, GlycoMimetics will
collaborate with both the NCI and the Alliance for Clinical Trials
in Oncology to conduct a randomized, controlled clinical trial
testing the addition of GMI-1271 to a standard
cytarabine/daunorubicin regimen (7&3) in older adults with
previously untreated acute myelogenous leukemia (AML) who are
suitable for intensive chemotherapy. This Phase 3 trial will be led
by Geoffrey Uy, M.D., Associate Professor of Medicine, Bone Marrow
Transplantation and Leukemia, Washington University School of
Medicine in St. Louis, and the primary endpoint will be overall
survival, with a planned interim analysis based on event-free
survival (EFS) after the first 250 patients have been enrolled in
the study.
“The NCI’s support of this clinical development program in AML
reflects a high-level of interest from the U.S.’s leading clinical
investigators and oncology thought leaders,” noted Helen Thackray,
M.D., FAAP, GlycoMimetics Senior Vice President, Clinical
Development, and Chief Medical Officer. “Based on our Phase 2 data,
we believe GMI-1271 has the ideal profile to become the possible
foundation of treatment across the continuum of care in AML. This
is an important collaboration for us as we seek to realize the full
potential of this novel therapeutic.”
Under the terms of the CRADA, the NCI may also fund additional
research, including clinical trials involving pediatric patients
with AML as well as preclinical experiments and clinical trials
evaluating alternative chemotherapy regimens. GlycoMimetics will
supply GMI-1271 as well as provide financial support to augment
data analysis and monitoring for the Phase 3 program.
In addition, GlycoMimetics announced that the generic name for
GMI-1271 will be uproleselan, and the drug candidate will be
referred to by this name going forward.
About GMI-1271 (Uproleselan)
GMI-1271 is designed to block E-selectin (an adhesion molecule
on cells in the bone marrow) from binding with blood cancer cells
as a targeted approach to disrupting well-established mechanisms of
leukemic cell chemoresistance within the bone marrow
microenvironment. In a Phase 1/2 clinical trial, GMI-1271 was
evaluated in both newly diagnosed elderly and relapsed/refractory
patients with acute myeloid leukemia (AML). In both populations,
patients treated with GMI-1271 together with standard chemotherapy
achieved better than expected remission rates and overall survival
compared to historical controls, which have been derived from
results from third party clinical trials evaluating standard
chemotherapy, as well as lower than expected induction-related
mortality rates. Treatment in these patient populations was
generally well tolerated, with fewer than expected adverse effects.
The FDA has granted GMI-1271 Breakthrough Therapy designation
for the treatment of adult AML patients with
relapsed/refractory disease.
About GlycoMimetics, Inc.
GlycoMimetics is a clinical-stage biotechnology company
focused on the discovery and development of novel glycomimetic
drugs to address unmet medical needs resulting from diseases in
which carbohydrate biology plays a key role. GlycoMimetics' most
advanced drug candidate, rivipansel, a pan-selectin antagonist, is
being developed for the treatment of vaso-occlusive crisis in
sickle cell disease and is being evaluated in a Phase 3 clinical
trial being conducted by its strategic collaborator, Pfizer.
GlycoMimetics' wholly-owned drug candidate, GMI-1271
(uproleselan), an E-selectin antagonist, was evaluated in a Phase
1/2 clinical trial as a potential treatment for AML and is
currently being evaluated in a Phase 1 clinical trial for the
treatment of multiple myeloma. The FDA granted GMI-1271
Breakthrough Therapy designation for the treatment of adult
AML patients with relapsed/refractory disease.
GlycoMimetics is also conducting a Phase 1 clinical trial with
a third drug candidate, GMI-1359, a combined CXCR4 and E-selectin
antagonist. GlycoMimetics is located in Rockville,
MD in the BioHealth Capital Region. Learn more
at www.glycomimetics.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements regarding
the clinical development of the company’s drug candidates,
including the expected timing of completion of clinical trials and
the presentation of clinical data. Actual results may differ
materially from those in these forward-looking statements. For a
further description of the risks associated with these statements,
as well as other risks facing GlycoMimetics, please see the risk
factors described in the company’s annual report on Form 10-K filed
with the U.S. Securities and Exchange Commission (SEC) on March 6,
2018, and other filings GlycoMimetics makes with the SEC from time
to time. Forward-looking statements speak only as of the date of
this release, and GlycoMimetics undertakes no obligation to update
or revise these statements, except as may be required by law.
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version on businesswire.com: https://www.businesswire.com/news/home/20180530005852/en/
GlycoMimetics, Inc.Investor Contact:Shari Annes,
650-888-0902sannes@annesassociates.comorMedia Contact:Jamie
Lacey-Moreira, 410-299-3310jamielacey@presscommpr.com
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