GlycoMimetics’ GMI-1271 Receives EU Orphan Drug Designation for Acute Myeloid Leukemia
May 25 2017 - 9:25AM
Business Wire
GlycoMimetics, Inc. (NASDAQ: GLYC) today announced that the
European Commission, based on a favorable recommendation from the
European Medicines Agency (EMA) Committee for Orphan Medicinal
Products, has granted orphan designation for the company’s drug
candidate GMI-1271 for the treatment of acute myeloid leukemia
(AML). The U.S. Food and Drug Administration (FDA) previously
granted orphan drug designation for GMI-1271 for the treatment of
AML in May of 2015.
GMI-1271, a specific E-selectin inhibitor is being evaluated in
the company’s ongoing Phase 1/2 clinical trial, in which clinicians
are evaluating the use of GMI-1271 along with chemotherapy in
patients with relapsed or refractory AML as well as those with
newly diagnosed AML. Earlier this month, the company announced that
GMI-1271 had been granted Breakthrough Therapy designation by the
FDA. The company also announced that abstracts had been published
by both the American Society of Clinical Oncology (ASCO) and the
European Hematology Association (EHA) highlighting new data from
the Phase 2 portion of the company’s ongoing Phase 1/2 trial that
will be presented at their upcoming annual meetings in June.
“The European orphan designation will provide incentives for the
commercialization and development of GMI-1271 in AML, where there
are limited therapies available to patients,” said Helen Thackray,
M.D., FAAP, Senior Vice President, Clinical Development and Chief
Medical Officer of GlycoMimetics. "We believe that GMI-1271, when
combined with standard chemotherapy, has the potential to address
an unmet therapeutic need for individuals living with AML, and we
are encouraged by both our clinical results to date and achieving
this designation from the European Commission."
The European Commission grants orphan designation to drugs
intended to treat, prevent or diagnose life-threatening or
chronically debilitating rare disorders, defined as diseases with
prevalence of no more than 5 in 10,000 in the EU, for which no
satisfactory method of diagnosis, prevention or treatment yet
exists. Orphan designation provides benefits including
commercialization incentives, protection of intellectual property,
including 10 years of market exclusivity and protocol assistance
through the EMA’s Scientific Advice program.
About AML
AML is a cancer of the blood and bone marrow. AML is the most
common type of acute leukemia in adults. The National Cancer
Institute estimates that there will be over 21,000 new cases of AML
diagnosed in 2017 in the United States, and over 10,000 people will
die from all forms of the disease in 2017. AML is more commonly
present in elderly patients. 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, a specific
E-selectin inhibitor, is being evaluated in an ongoing Phase 1/2
clinical trial as a potential treatment for AML and in a Phase 1
clinical trial for the treatment of 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 completion of ongoing clinical trials
and 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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GlycoMimetics, Inc.Investor Contact:Shari Annes,
650-888-0902sannes@annesassociates.comorMedia Contact:Jamie
Lacey-Moreira, 410-299-3310jamielacey@presscommpr.com
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