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Evaluating previously untreated newly diagnosed adults with acute
myeloid leukemia (AML) who are fit for intensive chemotherapy - Second initiation among three late-stage uproleselan clinical trials
ROCKVILLE, Md.–(BUSINESS WIRE)–GlycoMimetics, Inc. (NASDAQ: GLYC) announced today dosing of the first
patient in a Phase 3 clinical trial being conducted under the auspices
of a Cooperative Research and Development Agreement (CRADA) between
GlycoMimetics and the National Cancer Institute (NCI), part of the
National Institutes of Health. The second in a series of trials designed
to evaluate uproleselan across the continuum of care in AML, this
NCI-sponsored study is evaluating the addition of uproleselan to a
standard cytarabine/daunorubicin regimen (7&3) in older adults with
previously untreated AML who are suitable for intensive chemotherapy. A
third trial, to be conducted by the European HOVON consortium, is
expected to initiate later this year.
“The initiation of the NCI-sponsored trial is an important milestone for
our uproleselan program, a drug candidate with the potential to address
significant unmet treatment needs across the spectrum of AML,” noted
Helen Thackray, M.D., FAAP, GlycoMimetics Senior Vice President,
Clinical Development, and Chief Medical Officer. “Along with our global
pivotal Phase 3 clinical trial testing the investigational drug in
patients with relapsed/refractory acute myeloid leukemia, this trial
will facilitate our growing understanding of how uproleselan may fit
into the continuum of care for individuals living with AML.”
GlycoMimetics is collaborating with both the NCI and the Alliance for
Clinical Trials in Oncology to conduct the trial, which is led by
Geoffrey Uy, M.D., Associate Professor of Medicine, Bone Marrow
Transplantation and Leukemia, Washington University School of Medicine
in St. Louis. 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. More information on
this clinical trial can be found at www.clinicaltrials.gov.
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 in December 2018. 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 survival relative to matched,
historical controls.
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
implementing a comprehensive development program across the clinical
spectrum of AML.
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 being evaluated
across a range of patient populations including a company-sponsored
Phase 3 trial in relapsed/refractory AML. 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 regarding the
clinical development and regulatory pathway of the Company’s drug
candidates, including the expected enrollment in and conduct of clinical
trials, expected timelines related to the announcement of top-line
rivipansel data, the potential for rivipansel and the Company’s other
drug candidates to be attractive therapies if approved and the expected
safety and efficacy of the Company’s drug candidates based on data from
completed clinical trials. 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, 2019, 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.
Contacts
Investor Contact:
Shari Annes
Phone: 650-888-0902
Email:
sannes@annesassociates.com
Media Contact:
Jamie Lacey-Moreira
Phone: 410-299-3310
Email:
jamielacey@presscommpr.com