- Company to provide update and host
conference call today on clinical data to be presented at 2017 ASCO
and EHA Meetings
GlycoMimetics, Inc. (NASDAQ: GLYC) today announced the release
of abstracts containing new data from the ongoing Phase 2 clinical
trial of its product candidate GMI-1271, an E-selectin antagonist,
in patients with acute myeloid leukemia (AML). The data will be
presented at the June annual meetings of the American Society of
Clinical Oncology (ASCO) and the European Hematology Association
(EHA). The data released by ASCO and EHA, which reflect a
late-January analysis, will be updated in posters presented at both
meetings.
In the ongoing Phase 2 trial, AML patients treated with
GMI-1271, combined with chemotherapy, continue to experience
higher-than-expected remission rates and lower-than-expected
induction-related mortality rates in both arms of the trial. In
addition, researchers have observed that baseline expression of the
E-selectin ligand biomarker on leukemia cells was predictive of
clinical response and tied to greater likelihood of achieving
remission in the cohort of AML patients with relapsed/refractory
disease, which supports the mechanism of action of GMI-1271.
Treatment with GMI-1271 continues to be well tolerated, with no
obvious incremental toxicity observed when GMI-1271 is added to
chemotherapy.
According to Helen Thackray, MD, Chief Medical Officer, “The
data has consistently shown good tolerability and high remission
rates as well as lower than expected 30- and 60-day mortality rates
in early evaluations of patients. We are increasingly confident
that our investigational drug, GMI-1271, may play a role in
addressing unmet needs in this cancer. It is particularly
noteworthy to see in the relapsed/refractory cohort that patients
who have higher levels of the E-selectin ligand biomarker on their
leukemic blasts appear to be more likely to achieve remission of
their disease. This observation builds directly on what we and
others have reported in the preclinical and clinical settings about
the key role E-selectin plays in many forms of cancer, including
AML. Importantly, this provides what we believe is the first direct
clinical evidence of the potential benefit of targeting of
E-selectin in this difficult-to-treat population of AML
patients.”
Relapsed or Refractory Disease Arm:
Abstract Data
Consistent with GlycoMimetics’ prior published research, the
addition of GMI-1271 to mitoxantrone, etoposide and cytarabine
(MEC) chemotherapy has been well-tolerated, with patients achieving
a high overall response rate (ORR), low induction mortality, and
promising initial survival outcomes. The data show that baseline
expression of the E-selectin ligand biomarker was predictive of
response. GlycoMimetics believes these results are better than what
would be expected in this population, based on published historical
controls in similar patients.
Highlights of the data reported in the published abstract
include:
- 47 patients were enrolled.
- 30- and 60-day mortality were 0 and 7%,
respectively.
- ORR was 21/42 evaluable (50%).
- Median Overall Survival in the Phase 1
portion was 7.6 months.
- The median E-selectin ligand binding at
baseline was 35% of blasts (range, 1-75%) and, importantly, was
higher in those achieving remission.
The data from the ongoing Phase 2 trial were submitted to the
U.S. Food and Drug Administration (FDA). As announced yesterday,
GMI-1271 was granted Breakthrough Therapy designation from the FDA
for the treatment of adult AML patients with relapsed/refractory
disease. The FDA had previously granted Orphan Drug designation and
Fast Track Status for GMI-1271 for the treatment of AML.
Newly Diagnosed, Treatment-Naïve, Elderly
Arm: Abstract Data
In the published abstract, data reflects 17 of 24 enrolled and
evaluable elderly patients. Highlights from the abstract
include:
- The remission rate (CR/CRi) was 12/17
(71%).
- CR/CRi rate was 75% for patients with
de novo disease and 67% for patients with secondary AML.
GlycoMimetics noted that the safety profile of the
investigational drug, GMI-1271, in combination with chemotherapy is
encouraging. Outcomes for elderly patients with AML remain poor,
and tolerability of treatments is a key concern.
Conference Call Today
Company management will host a conference call today, Thursday,
May 18, 2017 at 8:30 a.m. Eastern time to provide a
clinical data update from the abstracts for the upcoming ASCO
conference. A question and answer session with the GlycoMimetics
team will follow the company's remarks. The call can be accessed by
dialing (844) 413-7154 (U.S. and Canada) or (216)
562-0466 (international) and entering passcode 4110139. To access
the live audio webcast, or the subsequent archived recording, visit
the "Investors - Events & Presentations" section of the
GlycoMimetics website at www.glycomimetics.com. The webcast will be
recorded and available for replay on the GlycoMimetics website for
30 days following the call.
About the Phase 1/2 Trial
The trial is comprised of two arms, one treating newly diagnosed
AML patients 60 years of age and older and the other, treating
adult patients with relapsed or refractory disease. The enrollment
of the cohort of newly diagnosed patients is complete; enrollment
of the cohort with relapsed/refractory disease is expected to
complete by mid-year. GlycoMimetics intends to enroll a total of
approximately 90 patients in the trial, of which approximately 25
have newly diagnosed disease and approximately 65 have relapsed or
refractory disease. Initial results of this study were first
reported at the EHA 2016 meeting in Copenhagen, and GlycoMimetics
provided an update at the December 2016 American Society of
Hematology (ASH) meeting.
Details of the ASCO
Presentations
Abstract #2520
Poster with discussion. DeAngelo, D.J., et al. "GMI-1271, a
Novel E-Selectin Antagonist, in Combination with Chemotherapy in
Relapsed/Refractory AML." Poster Session: Developmental
Therapeutics—Clinical Pharmacology and Experimental Therapeutics.
Monday, June 5, 8:00-11:30 a.m. CT. Poster Discussion Session:
Developmental Therapeutics—Clinical Pharmacology and Experimental
Therapeutics, Monday, June 5, 11:30 a.m.-12:45 p.m. CT.
Presenter: Daniel J. DeAngelo, MD, PhD, Dana-Farber Cancer
Institute Director of Clinical and Translational Research, Adult
Leukemia; Harvard Medical School Associate Professor of
Medicine
Abstract #2560
Poster. DeAngelo, D.J. et al. "GMI-1271, a Novel E-Selectin
Antagonist, Combined with Induction Chemotherapy in Elderly
Patients with Untreated AML." Session Title: Poster Session:
Developmental Therapeutics—Clinical Pharmacology and Experimental
Therapeutics. Monday, June 5, 8:00-11:30 a.m. CT.
Presenter: Dr. DeAngelo
The ASCO Annual Meeting 2017 takes place from June 2 to 5, at
McCormick Place in Chicago. Meeting abstracts are available at
ASCO’s website.
Details of the EHA
presentations
Abstract Code: P547
Poster. DeAngelo, D.J., et al. “GMI-1271, A Potent E-Selectin
Antagonist, In Combination With Chemotherapy In Relapsed/Refractory
AML: A Novel, Well-Tolerated Regimen With A High Remission Rate.”
Session Title: Acute myeloid leukemia – Clinical 4. Saturday, June
24, 17:30 – 19:00. Poster area (Hall 7).
Presenter: Dr. DeAngelo
Abstract Code: P203
Poster. DeAngelo, D.J., et al. “GMI-1271, A Potent E-Selectin
Antagonist, Combined With Induction Chemotherapy In Elderly
Patients with Untreated AML: A Novel, Well-Tolerated Regimen With A
High Remission Rate.” Session Title: Acute myeloid leukemia –
Clinical 2. Friday, June 23, 17:15 – 18:45. Poster area (Hall
7).
Presenter: Dr. DeAngelo
The 22nd Congress of EHA (European Hematology Association) takes
place from June 22 to 25, 2017 in Madrid, Spain. Meeting abstracts
will be available at EHA's website.
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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GlycoMimeticsInvestor Contact:Shari Annes,
650-888-0902sannes@annesassociates.comorMedia Contact:Jamie
Lacey-Moreira, 410-299-3310jamielacey@presscommpr.com
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