Remission rates continue to be higher than historical controls and
induction-related mortality continues to be lower than historical
GMI-1271 continues to be well tolerated in combination with
Only one case of severe (Grade 3/4) mucositis reported among 79
patients receiving high-intensity induction chemotherapy
Relapsed/refractory patients with more blasts expressing the
E-Selectin ligand were more likely to achieve complete response (p
Initial duration of response data is encouraging
ROCKVILLE, Md.--(BUSINESS WIRE)--
GlycoMimetics, Inc. (NASDAQ:GLYC) today announced new and updated data
from the Phase 2 portion of its ongoing Phase 1/2 clinical trial that
showed high remission and low mortality rates of its drug candidate
GMI-1271, an E-selectin antagonist being developed as a treatment for
patients with acute myeloid leukemia (AML). Clinical investigators are
presenting the data today from 79 patients in the trial via posters and
discussion at the 2017 annual meeting of the American
Society for Clinical Oncology (ASCO) in Chicago. In this trial,
patients treated with GMI-1271 together with standard chemotherapy
continue to achieve higher than expected remission rates based on
historical controls, as well as lower than expected induction-related
mortality rates. Treatment also continues to be well tolerated in this
"We are excited to share this promising new data for GMI-1271, which
continue to support the potential for this new drug candidate to treat
AML, a disease that has often eluded medical interventions thus far,"
said Rachel King, Chief Executive Officer of GlycoMimetics. "We are
increasingly optimistic that GMI-1271 may help address unmet needs in
this and other cancers."
Among the 54 relapsed/refractory AML patients participating in the trial
for whom data is available:
The overall response rate (complete remission/complete remission with
incomplete marrow recovery, or CR/CRi) was 41 percent, which is higher
than historical controls, and the 60-day induction related mortality
rate was 7 percent, which is lower than historical controls.
Oral mucositis, or inflammation with mouth ulcers that is a sign of
adverse effects of chemotherapy, was seen at low rates and severity
with only one Grade 3/4 event observed.
The median overall survival time for Phase 1 trial patients was 7.6
Remissions were durable enough to allow 9 patients to receive stem
For patients in the Phase 1 portion of the trial who responded with a
remission, more than half survived for at least a year after treatment.
Among the 25 newly diagnosed elderly patients (age 60 and older)
participating in the trial for whom data is available:
The overall response (CR/CRi) rate was 68 percent, with 73 percent in
patients with de novo AML and 64 percent in patients with secondary
The 60-day mortality rate was 8 percent.
There were no cases of grade 3 or 4 mucositis.
For the 9 evaluable patients achieving CR/CRi, disease-free survival
was 100% at 6 months after treatment.
"These results are very encouraging, indicating that the E-selectin
antagonist may enhance our ability to improve the
complete remission rate and potentially to improve the tolerability of
intensive chemotherapy for patients with acute myeloid leukemia," said
Daniel J. DeAngelo, MD, PhD, the trial's Lead Investigator, who serves
as Dana-Farber Cancer Institute Director of Clinical and Translational
Research, Adult Leukemia, and Institute Physician, and Associate
Professor of Medicine at Harvard Medical School. "We look forward to
continuing our clinical testing of GMI-1271 and further examining its
potential for improving outcomes for patients with AML."
The ASCO Annual Meeting is taking place from June 2-5, 2017 at McCormick
Place in Chicago. More detail and the meeting abstracts are available at ASCO's
Data from the Phase 1/2 trial were submitted to the U.S. Food and Drug
Administration (FDA). In May 2017, the FDA granted GMI-1271 Breakthrough
Therapy designation for treatment of adult patients with
relapsed/refractory AML. In addition, GMI-1271 has been granted Orphan
Drug designation and Fast Track status by the FDA and Orphan Drug
designation by the European Commission.
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. The U.S. FDA recently
granted GMI-1271 Breakthrough Therapy designation for treatment of adult
AML patients with relapsed/refractory disease. 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.
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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170605005304/en/
Shari Annes, 650-888-0902
Source: GlycoMimetics, Inc.
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