ROCKVILLE, Md.--(BUSINESS WIRE)--
(NASDAQ:GLYC) today announced that it received Fast
Track designation from the U.S. Food and Drug Administration
its novel E-selectin antagonist GMI-1271 for treatment of adult patients
with relapsed or refractory acute myeloid leukemia (AML) and elderly
patients aged 60 years or older with AML.
"We believe GMI-1271 has the potential to address important unmet needs
for individuals with relapsed or refractory AML, as well as for older
AML patients, for whom the standard of care often fails to provide
outcomes as positive as those seen in other patient groups," said Helen
Thackray, M.D., Chief Medical Officer of GlycoMimetics. "The FDA's
granting of a Fast Track designation for GMI-1271 to treat AML is an
important step in advancing this drug candidate through the regulatory
process, and if successful, in bringing a novel drug to patients in an
expedited time frame."
The Fast Track Designation is designed to facilitate development and
expedite review of experimental therapies that address the unmet medical
needs of patients with serious conditions.
AML is a cancer of immature white blood cells that starts in the bone
marrow but can quickly spread into the blood, lymph nodes, liver,
spleen, central nervous system, and testicles. 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. Chemotherapeutic methods among
patients with refractory and relapsed AML have low remission rates,
between 25 and 30 percent.
GlycoMimetics announced on Friday, June 10, presentation of data from
the Phase 1 portion of its on-going Phase 1/ 2 clinical trial testing
GMI-1271 combined with induction chemotherapy, in patients with
relapsed/refractory acute myeloid leukemia (AML). Data was reported at
the European Hematology Association 21st
Congress in Copenhagen, Denmark in a poster entitled "Results of a
Phase 1 study of GMI-1271, a potent E-selectin antagonist in combination
with induction chemotherapy in relapsed/refractory AML: a novel,
well-tolerated regimen with a high remission rate."
In addition, GlycoMimetics recently announced that the first patient
with relapsed or refractory AML has been dosed in the company's Phase 2
portion of the ongoing Phase 1/2 clinical trial of GMI-1271. This
clinical trial is a multinational open-label study evaluating endpoints
for safety, pharmacokinetics (PK) and efficacy of GMI-1271 in
combination with induction chemotherapy in patients with high-risk AML.
This trial is being conducted at a number of academic medical
institutions in the United States, Ireland, and Australia. While the
primary objective is to assess safety, additional endpoints include
overall response rate, biomarkers of activity, durability of response
and overall survival. The Phase 2 portion of the study is expected to
include approximately 25 participants with relapsed or refractory AML
and approximately 25 participants who are newly diagnosed.
GMI-1271 is designed to block E-selectin (an adhesion molecule on cells
in the bone marrow) from binding with AML 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 expects to file an IND with the FDA for a third drug
candidate, GMI-1359, a combined CXCR4 and E-selectin antagonist, in the
third quarter of 2016. GlycoMimetics is located in Rockville, MD in the
BioHealth Capital Region. Learn more at www.glycomimetics.com.
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