GlycoMimetics Completes Enrollment of Newly Diagnosed AML Patient Cohort in Phase 2 Clinical Trial of
GMI-1271
GlycoMimetics, Inc. (NASDAQ:GLYC) today announced that the first of two patient cohorts in its Phase 2 acute myeloid leukemia
(AML) trial of GMI-1271 has completed enrollment. This cohort is comprised of 25 patients 60 years of age or older with newly
diagnosed AML. The study is designed to evaluate the potential of GMI-1271, GlycoMimetics’ E-selectin antagonist drug candidate, in
combination with chemotherapy, as a treatment for patients with both newly diagnosed and relapsed/refractory AML. Enrollment in the
study’s second arm is expected to complete in the middle of this year. The two arms combined will enroll a total of about 90
patients.
“At the ASH meeting in December, we showed that GMI-1271 was well-tolerated and demonstrated a high remission rate among the
patient volunteers who were enrolled early in the study,” said Helen Thackray, M.D., Chief Medical Officer of GlycoMimetics. “We are enthusiastic about that data, and as such,
we look forward to opportunities later in the year to report initial treatment outcomes for this study.”
GMI-1271 data were presented in 2016 at meetings of the European Hematology Association (EHA) and the American Society of
Hematology (ASH), showing high remission rates and lower than expected 30- and 60-day mortality rates in early evaluations of
patients with relapsed/refractory AML.
In addition to the ongoing Phase 1/2 trial, clinical investigators are currently evaluating GMI-1271 in an ongoing Phase 1
clinical trial in multiple myeloma. Preclinical data supporting the multiple myeloma study is scheduled to be shared in an oral
presentation at the American Association of Cancer Research (AACR) Annual Meeting 2017 in April. Specifically, the newly
announced preclinical results show a strong effect on cancer cells in combination with chemotherapy and are supportive of the
ongoing Phase 1 clinical studies of GMI-1271 in multiple myeloma.
About AML
Acute myeloid leukemia (AML) is a cancer of the blood and bone marrow. AML is the most common type of acute leukemia in adults.
Each year in the United States, about 19,900 people (usually older than 45 years of age) are diagnosed, and about 10,400 people die
from all forms of the disease, according to the American Cancer Society. Unlike other cancers that start in an organ and spread to
the bone marrow, AML is known for rapid growth of abnormal white blood cells that gather in the bone marrow, getting in the way of
normal blood cell production. The lack of normal blood cells can cause some of the symptoms of AML, including anemia (shortage of
red blood cells resulting in tiredness and weakness), neutropenia (shortage of white blood cells that may lead to increased
infections), and thrombocytopenia (shortage of platelets in the blood that may lead to excessive bleeding). Current treatment
options for AML consist of reducing and eliminating cancer cells mainly through chemotherapy, radiation therapy, and stem cell
transplantation.
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 and in a Phase 1 clinical trial in multiple myeloma. 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.
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-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.
For GlycoMimetics, Inc.
Investors:
Shari Annes, 650-888-0902
sannes@annesassociates.com
or
Media:
Jamie Lacey-Moreira, 410-299-3310
jamielacey@presscommpr.com
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