GlycoMimetics Initiates Dosing in Phase 1 Clinical Trial of GMI-1359

ROCKVILLE, Md.–(BUSINESS WIRE)–GlycoMimetics, Inc. (NASDAQ: GLYC) today announced dosing of the first
healthy volunteers in a new Phase 1 clinical trial evaluating its novel
combined E-selectin and CXCR4 antagonist GMI-1359. In this
first-in-humans trial, volunteer participants will receive a single
injection of GMI-1359, which will be evaluated for safety, tolerability,
pharmacokinetics and pharmacodynamics. GlycoMimetics intends to develop
GMI-1359 as a potential treatment for hematologic malignancies.
“Our preclinical data points to the potential of GMI-1359 to inhibit the
growth and metastasis of a variety of cancers. We believe this is due to
a novel mechanism of action provided by inhibiting both E-selectin and
CXCR4 simultaneously,” said Helen
Thackray, M.D., Chief Medical Officer of GlycoMimetics. “This first
clinical trial will position the program for further development in
hematologic malignancies and other cancers.”
The randomized, double-blind escalating dose study is being conducted at
a single site in the United States. Each volunteer will receive a single
dose of GMI-1359, and participate for 16 days of evaluation during the
trial.
Previous preclinical research has been shared via oral and poster
presentations at the annual meetings of both the American Association
for Cancer Research Annual and the American Society of Hematology. Data
presented have demonstrated activity in models of acute myelogenous
leukemia (AML), prostate cancer and pancreatic cancer.
About GlycoMimetics, Inc.
GlycoMimetics is a clinical-stage biotechnology company focused on
cancer and sickle cell disease. 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, an E-selectin antagonist, is being evaluated in an
ongoing Phase 1/2 clinical trial as a potential treatment for AML .
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
GlycoMimetics’ planned activities with respect to the clinical
development of its drug candidate GMI-1359. Actual results may differ
materially from those indicated by such forward-looking statements as a
result of various important factors, including the availability and
timing of data from ongoing clinical trials, the uncertainties inherent
in the initiation of future clinical trials, whether interim results
from a clinical trial will be predictive of the final results of the
trial or results of early clinical trials will be indicative of the
results of future trials, expectations for regulatory approvals,
availability of funding sufficient for GlycoMimetics’ foreseeable and
unforeseeable operating expenses and capital expenditure requirements,
other matters that could affect the availability or commercial potential
of GlycoMimetics’ drug candidates and other factors discussed in the
“Risk Factors” section of GlycoMimetics’ Annual Report on Form 10-K that
was filed with the U.S. Securities and Exchange Commission on February
29, 2016, and other filings GlycoMimetics makes with the Securities and
Exchange Commission from time to time. In addition, the forward-looking
statements included in this press release represent GlycoMimetics’ views
as of the date hereof. GlycoMimetics anticipates that subsequent events
and developments may cause its views to change. However, while
GlycoMimetics may elect to update these forward-looking statements at
some point in the future, GlycoMimetics specifically disclaims any
obligation to do so, except as may be required by law. These
forward-looking statements should not be relied upon as representing
GlycoMimetics’ views as of any date subsequent to the date hereof.