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Proof-of-concept trial to evaluate safety and biomarkers of cancer
cell mobilization in patients with hormone receptor positive
metastatic breast cancer -
Novel GlycoMimetics drug candidate targets tumor and bone marrow
microenvironments
ROCKVILLE, Md.–(BUSINESS WIRE)–GlycoMimetics, Inc. (NASDAQ: GLYC) today announced plans to initiate a
clinical trial of GMI-1359 in breast cancer patients whose tumors have
spread to bone. GMI-1359 is a dual function antagonist that targets both
E-selectin and CXCR4, both of which are involved in tumor trafficking
and metastatic spread. The trial will evaluate dose escalation as well
as safety and pharmacodynamic markers in these patients.
The trial’s Co-Principal Investigators are Kelly Marcom, M.D., and
Dorothy Sipkins, M.D., Ph.D., both of the Duke Cancer Institute. Dr.
Sipkins has previously published on the key roles of both E-selectin and
CXCR4 in the trafficking of metastatic cancer cells and of their
establishment as micro-metastases in bone.1
“Dr. Sipkins’ work suggests that both E-selectin and CXCR4 mediate key
mechanisms that promote progression and migration of circulating cancer
cells to protective niches. Importantly, her work reveals a potentially
exciting approach to molecularly excise disseminated breast cancer cells
with GMI-1359, which was rationally designed to inhibit both of these
targets,” said John Magnani, Ph.D., Senior Vice President and Chief
Scientific Officer at GlycoMimetics.
“Our preclinical research in mice suggests that targeting E-selectin and
CXCR4 with a single agent may potentially improve treatment of patients
at risk of metastasis to bone, or whose tumors might have already
spread,” said Dr. Sipkins.
“If ultimately shown safe and effective in clinical trials, this agent
could represent a potentially novel approach to treating metastatic
cancer, and we’re pleased to begin exploring the use of this
investigational therapy in individuals with metastatic cancer,” added
Dr. Marcom.
GlycoMimetics expects to initiate this trial in 2H 2019.
About GMI-1359
GMI-1359 is designed to simultaneously inhibit both E-selectin and
CXCR4. E-selectin and CXCR4 are both adhesion molecules involved in
tumor trafficking and metastatic spread. Preclinical studies indicate
that targeting both E-selectin and CXCR4 with a single compound could
improve efficacy in the treatment of cancers that involve the bone
marrow such as AML and multiple myeloma or in solid tumors that
metastasize to the bone, such as prostate cancer and breast cancer.
GMI-1359 has completed a Phase 1 clinical trial in healthy volunteers.
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 and potential benefits and
impact 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 to be filed with the U.S.
Securities and Exchange Commission (SEC) on or about 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.
1 Price et. al. Science Translational Medicine,
(2016) 8:340.
Contacts
Investor Contact:
Shari Annes, 650-888-0902
sannes@annesassociates.com
Media
Contact:
Jamie Lacey-Moreira, 410-299-3310
jamielacey@presscommpr.com