GlycoMimetics’ GMI-1271 Receives FDA Breakthrough Therapy Designation for Adult Relapsed/Refractory Acute Myeloid Leukemia
May 17 2017 - 4:10PM
Business Wire
GlycoMimetics, Inc. (NASDAQ: GLYC) today announced that the U.S.
Food and Drug Administration (FDA) has granted Breakthrough Therapy
designation for treatment of adult relapsed/refractory acute
myeloid leukemia (AML) to the company’s drug candidate GMI-1271, an
E-selectin antagonist currently being evaluated in the Phase 2
portion of a Phase 1/2 clinical trial in patients with AML. The
U.S. Food and Drug Administration (FDA) had previously granted
Orphan Drug designation and Fast Track Status for GMI-1271 in
AML.
In the ongoing clinical trial, GMI-1271 is being administered,
along with chemotherapy, to patients with relapsed or refractory
AML as well as those 60 years of age and older with newly diagnosed
disease. Data from this trial were presented in 2016 at meetings of
the European Hematology Association (EHA) and
the American Society of Hematology (ASH). In the trial,
patients treated with GMI-1271 achieved higher than expected
remission rates and lower than expected 30- and 60-day mortality
rates in early evaluations of patients with relapsed/refractory AML
as well as in newly diagnosed patients. In March 2017, the Company
announced that the first of two patient cohorts in the Phase 2
portion of the trial of GMI-1271 had completed enrollment. In
April 2017, the Company announced plans to present further data
updates on both patient populations in the ongoing AML trial at the
2017 American Society of Clinical Oncology (ASCO) Annual Meeting in
June.
The FDA grants Breakthrough Therapy designation to companies to
help accelerate development and review of drug candidates when
preliminary clinical evidence indicates that the drug may
demonstrate substantial improvement over existing therapies. The
designation is designed to expedite the development and review of
designated therapies, without changing FDA standards for new drug
approval.
“The FDA’s granting to GMI-1271 of Breakthrough Therapy
designation will further help GlycoMimetics to accelerate the
development of GMI-1271 as a treatment for this very
difficult-to-treat patient population," said Helen Thackray, MD,
Chief Medical Officer of GlycoMimetics. “We believe GMI-1271 when
combined with chemotherapy has the potential to address an unmet
therapeutic need for individuals living with AML. We are encouraged
by our clinical results to date, and look forward to working
closely with the FDA to bring this novel therapy to patients as
quickly as possible.”
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 March 1, 2017
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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version on businesswire.com: http://www.businesswire.com/news/home/20170517006262/en/
GlycoMimetics, Inc.Investor Contact:Shari Annes,
650-888-0902sannes@annesassociates.comorMedia Contact:Jamie
Lacey-Moreira, 410-299-3310jamielacey@presscommpr.com
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