GlycoMimetics Enrolls First Patient in Global Phase 3 Clinical Trial of Uproleselan in Relapsed/Refractory Acute Myeloid Leuk...
November 19 2018 - 9:00AM
Business Wire
- Pivotal Trial to Evaluate Efficacy
and Safety of Uproleselan in Patients with Advanced Acute Myeloid
Leukemia (AML); Trial to Enroll 380 Patients at US and
International Sites
- Broad Late-stage Development Program in
Place to Evaluate Uproleselan Across the Continuum of Care in
AML
GlycoMimetics, Inc. (NASDAQ: GLYC) announced today dosing of the
first patient in the company’s Phase 3 clinical trial of
uproleselan (GMI-1271) in relapsed/refractory AML. The trial’s
protocol provides for administration of the investigational drug in
combination with MEC (mitoxantrone, etoposide and ara-C) or in
combination with FAI (fludarabine, ara-C and idarubicin), both of
which are standard of care for this indication in the United
States. In 2017, the U.S. Food and Drug Administration (FDA)
granted Breakthrough Therapy Designation to GlycoMimetics for
uproleselan in this patient population. The company anticipates the
initiation of two complementary Phase 2/3 trials from two leading
clinical consortia in early 2019.
“The dosing of the first patient in our pivotal Phase 3 trial
for uproleselan is an important milestone for GlycoMimetics,”
said Helen Thackray, M.D., FAAP, Senior Vice President,
Clinical Development, and Chief Medical Officer of GlycoMimetics.
“This is a rigorously designed Phase 3 trial that has the potential
to bring us one step closer to meeting the significant unmet needs
of individuals living with relapsed/refractory AML. The trial is an
important component of our comprehensive late-stage development
program for uproleselan that positions us to evaluate the use of
our product candidate across the spectrum of AML. It is the first
of three randomized, controlled trials for uproleselan in AML,
which we believe should provide clear efficacy and safety outcome
measures in each of the settings being assessed.”
“Our clinical development pipeline sets us up for multiple,
value-creating clinical data readouts,” added Rachel K. King,
GlycoMimetics Chief Executive Officer. “During 2019, we anticipate
topline data from the Phase 3 study of rivipansel being conducted
by Pfizer in patients with sickle cell disease. Then, beginning at
the end of 2020, we expect to generate topline data from the
several trials that we will have underway in AML.”
GlycoMimetics plans to enroll approximately 380 adult patients
worldwide in the single pivotal randomized, double-blind,
placebo-controlled Phase 3 AML trial, which is designed to align
with guidance received from regulatory agencies. The primary
endpoint is overall survival, and censoring for transplant in the
primary efficacy analysis will not be required. Key secondary
endpoints include incidence of severe mucositis and remission rate,
which will be assessed in a hierarchical fashion for potential
inclusion in the product labeling. The majority of the study sites
will be in the United States, with meaningful participation from
leading clinical centers in other strategic countries to support
regulatory filings in major markets.
More information on the clinical trial can be found at
www.clinicaltrials.gov.
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, as well as lower than expected induction-related
mortality rates, as compared to historical controls which have been
derived from results from third party clinical trials evaluating
standard chemotherapy 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 FDA granted uproleselan Breakthrough Therapy
Designation for the treatment of adult acute myeloid leukemia
(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.
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 enrollment in and conduct of clinical
trials, the presentation of clinical data, and expiration of issued
patents. 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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