Trial to test candidate for second blood cancer type among
patients responding poorly to standard therapy
ROCKVILLE, Md.--(BUSINESS WIRE)--
GlycoMimetics, Inc. (NASDAQ: GLYC) today announced it has dosed its
first patient in a Phase 1 clinical trial of its novel E-selectin
antagonist, GMI-1271, combined with bortezomib-based chemotherapy, for
multiple myeloma. The trial marks a second application for GMI-1271,
which already is undergoing clinical study as a potential treatment for
acute myeloid leukemia (AML).
The newly initiated multi-center, open-label dose escalation trial,
which has begun in Ireland, will measure the efficacy, safety and
pharmacokinetics of GMI-1271 in combination with chemotherapy among
patients who have been diagnosed with multiple myeloma and have not
responded well to standard chemotherapy. The company anticipates
enrolling 24 participants in the trial.
"This new clinical trial provides an opportunity to evaluate GMI-1271's
ability to treat hematological cancers beyond AML," said Dr. John Quinn,
Consultant Haematologist, Beaumont Hospital, Dublin,
Ireland. "Preclinical studies showed promise for E-selectin antagonists
against other types of cancers, so this pilot study in multiple myeloma
may determine if GMI-1271 may become part of a bortezomib rescue
treatment for patients not responding to standard regimens." Beaumont
Hospital is one of a number of Blood Cancer Network Ireland (BCNI)
sites participating in this study.
In preclinical studies, mice with multiple myeloma that were treated
with GMI-1271 and bortezomib showed improvement in survival compared to
those treated with bortezomib alone. Furthermore, in mice with myeloma
resistant to treatment with bortezomib, addition of GMI-1271 restored
bortezomib sensitivity. In addition, blood samples from individuals with
multiple myeloma showed increases in cell surface expression of
E-selectin carbohydrate ligands when cancer had relapsed, indicating
E-selectin as a promising target for reducing drug resistance in certain
groups of patients who have the disease.
Multiple myeloma is a neoplastic proliferation of plasma cells derived
from bone marrow. The cells ultimately infiltrate a number of organs and
lead to bone marrow destruction and failure. It is the most common tumor
in the bone and the second most-common blood cancer in the US and
Europe. According to EU data from 2012, 39,000 new diagnoses were made
for multiple myeloma, and 24,000 people died from the disease there.
Most patients currently ultimately relapse from chemotherapy, and the
disease is not considered curable using current approaches.
In the Phase 1 study, participants will include individuals who have
been diagnosed with multiple myeloma and undergone bortezomib-based
therapy with inadequate responses. The patients will receive one of four
doses of GMI-1271 in combination with bortezomib, intravenously
concurrently with bortezomib treatment. They will be followed after
treatment to measure safety endpoints and efficacy.
GMI-1271 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. Preclinical research
points to the drug's potential role in moving cancerous cells out of the
protective environment of the bone marrow where they hide and escape the
effects of chemotherapy. In preclinical studies using animal models of
AML, the results of which were presented at meetings of the American
Society of Hematology (ASH), GMI-1271 was also associated with a
reduction of chemotherapy-induced neutropenia and chemotherapy-induced
About GlycoMimetics, Inc.
GlycoMimetics is a clinical-stage biotechnology company focused on
sickle cell disease and cancer. 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 has also recently initiated a 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.
This press release contains forward-looking statements regarding
GlycoMimetics' planned activities with respect to the clinical
development of its drug candidate GMI-1271. 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.
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Source: GlycoMimetics, Inc.
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