GlycoMimetics Presents New AML Data with Uproleselan at 60th ASH Annual Meeting
December 03 2018 - 7:00AM
Business Wire
- Data in relapsed/refractory and newly
diagnosed acute myeloid leukemia (AML) patients underscore clinical
opportunities across multiple outcomes measures and subgroups
- Selective disruption of bone marrow
microenvironment with uproleselan resulting in high remission
rates; majority of evaluable patients achieving stringent level of
measurable residual disease (MRD) negativity; promising survival
outcomes across all AML subgroups assessed
- Correlative studies further strengthen
scientific rationale for inhibiting E-selectin in patients with
AML, particularly those individuals with high-risk disease
GlycoMimetics, Inc. (NASDAQ:GLYC) announced today that new data
on uproleselan-treated high risk patients with both
relapsed/refractory and newly diagnosed AML were presented at an
oral session during the 60th American Society of Hematology
(ASH) Annual Meeting and Exposition. An analysis of clinical
outcomes from the Phase 1/2 clinical study showed that uproleselan
(GMI-1271) resulted in the majority of evaluable patients achieving
a stringent level of measurable residual disease (MRD) negativity,
an effect which translated into extended overall survival relative
to matched, historical controls.1-4
Additionally, an analysis of E-selectin ligand expression on
leukemic cells demonstrated that detectable levels are present in
every patient tested, providing strong clinical evidence of
biological relevance in this disease setting. In bone marrow
blasts, leukemic stem cell expression of E-selectin ligand
correlated with leukemic blast E-selectin ligand expression
(p<0.0001), consistent with the hypothesis that
E-selectin-mediated interactions are a mechanism of
chemoresistance. Additionally, investigators assessed the
association between baseline E-selectin ligand expression and
clinical outcomes using a log-rank test. In the R/R cohort of
patients (n=22), this analysis demonstrated that ≥10% E-selectin
ligand expression at baseline is correlated with prolonged survival
(p<0.01) for patients treated with uproleselan. This observation
is important since separately Chien et al. (Abstract 1513) report
that high levels of E-selectin ligand in patients not treated with
uproleselan correlate with worse clinical prognosis.
“The new MRD and correlative efficacy data in difficult-to-treat
patients, when combined with the already encouraging response rate
and survival results from this trial, further demonstrate the
potential of uproleselan to be an important new treatment option in
AML,” said Daniel J. DeAngelo, M.D., Ph.D., Chief of the
Division of Leukemia at the Dana-Farber Cancer Institute and
Brigham and Women’s Hospital, and the trial’s lead investigator.
“The fact that more than half of the evaluable patients achieved a
stringent level of MRD negativity is particularly noteworthy as
uproleselan’s mechanism of action is to selectively disrupt the
relationship between leukemic cells and the bone marrow
microenvironment.”
“It is now clearly established that patients with AML who
express E-selectin ligands on their leukemic cells have more
infiltrative, aggressive disease and significantly worse clinical
outcomes when not treated with uproleselan,” said Helen Thackray,
M.D., FAAP, GlycoMimetics Senior Vice President, Clinical
Development and Chief Medical Officer. “While we would expect
patients with R/R AML and >10% E-selectin ligand expression on
their leukemic blasts to do very poorly, it is extremely exciting
to see that the addition of uproleselan is resulting in
statistically significant improvements in clinical outcomes in
these high-risk patients. This is completely counterintuitive to
what you would expect and provides robust scientific evidence
suggesting that uproleselan is exerting biologic activity.”
The ASH presentations referenced above include:
Publication Number: 331TITLE: Uproleselan
(GMI-1271), an E-Selectin Antagonist, Improves the Efficacy and
Safety of Chemotherapy in Relapsed/Refractory (R/R) and Newly
Diagnosed Older Patients with Acute Myeloid Leukemia: Final,
Correlative and Subgroup Analyses
Publication Number: 1513TITLE: E-Selectin
Ligand Expression by Leukemic Blasts Is Associated with Prognosis
in Patients with AML
References1 Feldman et al, J Clin Oncol. 2005 Jun
20;23(18):4110-6.2 Greenberg et al, J Clin Oncol. 2004
Mar 15;22(6):1078-86.3 Lowenberg et al, N Engl J
Med. 2009 Sep 24;361(13).4 Lancet et al, Blood. 2014
May 22;123(21):3239-46.
About Uproleselan (GMI-1271)
Uproleselan (yoo’ pro le’sel an) 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 resistance within the
bone marrow microenvironment. In a Phase 1/2 clinical trial,
uproleselan was evaluated in both newly diagnosed elderly and
relapsed/refractory patients with AML. In both populations,
patients treated with uproleselan 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 U.S. Food and Drug Administration (FDA) has
granted uproleselan Breakthrough Therapy Designation for the
treatment of adult AML patients with relapsed/refractory (R/R)
disease. GlycoMimetics is currently implementing a comprehensive
development program across the clinical spectrum of AML. This
includes a company sponsored Phase 3 trial in R/R AML and two
consortia-sponsored trials in newly diagnosed patients. One
consortium trial is being sponsored by the NCI and will enroll
newly diagnosed patients fit for intensive chemotherapy. The other
trial is sponsored by the HOVON group in Europe and will enroll
newly diagnosed patients unfit for intensive chemotherapy.
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, 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 company-sponsored Phase 3 trial in relapsed/refractory
AML. The U.S. Food and Drug Administration granted uproleselan
Breakthrough Therapy designation for the treatment of adult
AML patients with relapsed/refractory disease.
GlycoMimetics has also completed 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.
Forward-Looking Statements
This press release contains forward-looking statements,
including statements regarding the clinical development and
potential utility of the company’s drug candidates. 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20181203005276/en/
Investors:Shari AnnesPhone: 650-888-0902Email:
sannes@annesassociates.com
Media:Jamie Lacey-MoreiraPhone: 410-299-3310Email:
jamielacey@presscommpr.com
GlycoMimetics (NASDAQ:GLYC)
Historical Stock Chart
From Aug 2024 to Sep 2024
GlycoMimetics (NASDAQ:GLYC)
Historical Stock Chart
From Sep 2023 to Sep 2024