- Encouraging Anti-Leukemic Activity Observed in Patients with
Advanced AML; Overall Response Rate of 62% in Initial Cohort of 13
Patients
GlycoMimetics, Inc. (NASDAQ: GLYC) today announced that of the first 13
evaluable patients in its clinical trial of GMI-1271 in combination with
chemotherapy in patients with relapsed/refractory acute myeloid leukemia
(AML), investigators have observed clinical responses in eight patients,
for an overall response rate of 62%. Of the eight objective responses,
seven patients achieved a complete response (CR), with the eighth
patient achieving complete response but with an incomplete blood count
recovery (CRi). GMI-1271 was also well tolerated in this group of 13
patients. The detailed findings have been submitted to a major
scientific meeting.
“We are encouraged by the responses seen so far in patients in this
trial,” said Daniel J. DeAngelo, M.D., Ph.D., Director of Clinical and
Translational Research of the Adult Leukemia Program at the Dana-Farber
Cancer Institute and the Principal Investigator on the trial. “Patients
with AML have such unsatisfactory treatment options that it is important
to continue enrolling patients into this trial to characterize the full
potential of GMI-1271.”
“I am pleased to see the favorable safety profile and early clinical
activity of GMI-1271 in these patients,” said Helen Thackray, M.D.,
Chief Medical Officer of GlycoMimetics. “We believe that by selectively
disrupting cell-adhesion-mediated drug resistance mechanisms within the
bone marrow, GMI-1271 may significantly enhance the efficacy of
chemotherapy, without adding incremental toxicity. We look forward to
presenting the complete safety, pharmacokinetics, pharmacodynamics and
anti-tumor activity, including durability of CRs, at an upcoming
scientific meeting.”
About the Phase 1/2 Clinical Trial
Following the completion of a Phase 1 trial in 2014, GlycoMimetics has
initiated a multinational, Phase 1/2, open-label trial in which
researchers are evaluating the safety, pharmacokinetics (PK) and
efficacy of GMI-1271 as an adjunct to standard chemotherapy in patients
with advanced AML. This trial is being conducted at a number of academic
institutions in the United States, Ireland and Australia. While the
primary objective is to assess safety, additional endpoints include
overall response rate, PK, biomarkers of activity, time to response,
durability of response and overall survival at six and 12 months.
The trial consists of two parts. In the Phase 1 portion, dose escalation
testing is being performed to determine a recommended GMI-1271 dose in
combination with standard chemotherapy. The Phase 1 dose-escalation
portion of the trial is continuing. In the Phase 2 portion,
dose-expansion testing will be conducted to obtain additional safety and
efficacy data in defined sub-populations of AML. GlycoMimetics plans to
enroll a total of approximately 75 patients in the trial.
About GMI-1271
GlycoMimetics is evaluating GMI-1271, a selective, potent, inhibitor of
E-selectin, as an adjunct to standard-of-care chemotherapy, such as
anthracycline and cytarabine-based combinations, in adults with AML as a
targeted approach to disrupting well-established mechanisms of leukemic
cell resistance within the bone marrow microenvironment.
In preclinical studies using animal models of AML, the results of which
were presented at meetings of the American Society of Hematology (ASH),
administration of GMI-1271 in combination with chemotherapy resulted in
improved survival when compared to treatment with chemotherapy alone. In
additional preclinical studies also presented at meetings of ASH,
GMI-1271 was also associated with a reduction of chemotherapy-induced
neutropenia and chemotherapy induced mucositis.
In other preclinical studies from which data was presented at the 2015
ASH annual meeting, GMI-1271 was observed to reverse molecular
mechanisms of chemotherapy resistance seen in multiple myeloma.
GlycoMimetics has initiated preparations for a Phase 1 multiple
dose-escalation clinical trial in defined populations of patients with
multiple myeloma and plans to initiate the trial in the second half of
2016.
GlycoMimetics owns all of the development and commercialization rights
to GMI-1271.
About AML
AML is a cancer of the blood and bone marrow. AML is the most common
type of acute leukemia in adults and the five-year survival rate is
approximately 24 percent. According to the Surveillance, Epidemiology,
and End Results Program managed by the National Cancer Institute, there
were an estimated 20,830 new cases of AML diagnosed in 2015 in the
United States and AML caused an estimated 10,460 deaths in 2015 in the
United States. 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 and as a result, impede normal
blood cell production. While leukemic cells move into the blood, 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 include chemotherapy and stem cell transplantation, both
of which can destroy cancer cells, but remission rates remain low and
relapsed disease remains a significant problem.
About GlycoMimetics, Inc.
GlycoMimetics is a clinical stage biotechnology company focused on the
discovery and development of novel glycomimetic drugs to address unmet
medical needs resulting from diseases in which carbohydrate biology
plays a key role. Glycomimetics are molecules that mimic the structure
of carbohydrates involved in important biological processes. Using its
expertise in carbohydrate chemistry and knowledge of carbohydrate
biology, GlycoMimetics is developing a pipeline of glycomimetic drug
candidates that inhibit disease-related functions of carbohydrates, such
as the roles they play in inflammation, cancer and infection. Learn more
at www.glycomimetics.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements regarding the
clinical development of GMI-1271 and the presentation of clinical data.
Actual results may differ materially from those in these forward-looking
statements. For a further description of the risks associated with these
statements, as well as other risks facing GlycoMimetics, please see the
risk factors described in the company’s annual report on Form 10-K that
was filed with the U.S. Securities and Exchange Commission on February
29, 2016, and other filings the company makes with the SEC from time to
time. Forward-looking statements speak only as of the date of this
release, and GlycoMimetics undertakes no obligation to update or revise
these statements, except as may be required by law.
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