- Clinical outcomes, including durability
of remission and median overall survival, in high-risk patients
plus safety and tolerability data presented in oral presentation at
American Society of Hematology Annual Meeting and Expo
- Second oral presentation highlights
underlying, differentiated mechanism of action for company’s lead
clinical candidate
GlycoMimetics, Inc. (NASDAQ: GLYC) today announced updated data
from the Phase 1/2 trial evaluating the safety, tolerability and
efficacy of GMI-1271 in patients with relapsed/refractory (R/R)
acute myeloid leukemia (AML) and in older adults with newly
diagnosed AML, including the following conclusions:
For patients with R/R AML treated at the Phase 2 dose (n = 54)
and for whom median follow up was 6.6 months:
- Clinical remission (CR+CRi) was
43%.
- Median overall survival was 9.4 months
(95% CI: 5.7 – 15.1 months; calculated by Kaplan Meier method).
This compares favorably to a median overall survival of up to 5.4
months reported for historical, matched controls treated with
mitoxantrone, etoposide and cytarabine (MEC) alone. 1,2
- Median duration of remission was 11.1
months (95% CI: 5.8-NA; calculated by Kaplan Meier method).
For older patients with newly diagnosed disease (n=25) and for
whom median follow up was 10.5 months:
- Clinical remission rate was 68%.
- Median overall survival was 15.8 months
(95% CI: 10.3 – NA; calculated by Kaplan Meier method). This
compares favorably to a historical median overall survival of
approximately 12 months in matched controls treated with 7+3
chemotherapy alone. 3,4
- Median duration of remission was 14.8
months (95% CI: 8.3 – NA; calculated by Kaplan Meier method).
- Median event free survival was 11.3
months.
The data were presented yesterday during an oral scientific
session at the 59th American Society of Hematology (ASH) Annual
Meeting and Expo in Atlanta.
Across both populations, GMI-1271 was well tolerated with no
obvious incremental toxicity observed and lower than expected rates
of severe, debilitating, grade 3-4 mucositis reported (e.g., 3%
incidence reported vs. historical 20-25% incidence with MEC
alone).
“These new data from our Phase 1/2 clinical trial demonstrate
that encouraging clinical outcomes are possible for both duration
of remission and survival endpoints when GMI-1271 is added to
chemotherapy in two distinct AML patient populations,” noted Helen
Thackray, M.D., FAAP, GlycoMimetics Senior Vice-President, Clinical
Development and Chief Medical Officer. “Beyond the high response
rates previously reported with GMI-1271, we can now point to
additional long-term endpoints that further support our plan to
move the drug candidate into a Phase 3 clinical trial scheduled to
begin in mid-2018. Importantly, with respect to safety, the low
mucositis rate in relapsed and refractory patients receiving MEC
induction chemotherapy -- where you would expect around 25% severe
mucositis -- is quite striking. This was predicted and explained by
preclinical models in which GMI-1271 blocked inflammatory
macrophages trafficking to the gut and thus prevented mucosal
injury.”
“These results continue to show that AML patients treated with
GMI-1271 consistently perform better than expected,” said Daniel J.
DeAngelo, M.D., Ph.D., the trial’s lead investigator and Director
of Clinical and Translational Research, Adult Leukemia Program, at
the Dana-Farber Cancer Institute and Brigham and Women’s
Hospital, who presented the data at the ASH Annual Meeting. “Our
Phase 2 population consists of very high-risk patients based on
age, disease status, and cytogenetic risk factors. The
updated data continue to support the concept that disrupting
the relationship between leukemic cells and the protective bone
marrow microenvironment, when combined with chemotherapy, could
improve the outlook and prognosis for these patients.”
The second oral presentation at the ASH meeting highlighted a
preclinical study in murine models of AML in which E-selectin was
shown to be upregulated, and AML cells binding to E-selectin
increased chemo-resistance by activating specific tumor cell
survival signaling pathways. This effect within the bone marrow
microenvironment is unique to E-selectin as compared to other
vascular adhesion molecules and can be blocked by GMI-1271. This
translational research provides important evidence that elucidates
how treatment with GMI-1271 appears to be improving sensitivity to
chemotherapy.
“Given response rates we’ve observed to date that suggest
clinical benefit in combination with chemotherapy in two AML
populations, this preclinical work provides important further
support for the mechanism of action of GMI-1271,” noted Dr.
Thackray. “Together, the clinical and preclinical data we have
shared at the ASH Annual Meeting demonstrate that GMI-1271 could
represent a novel and truly differentiated approach to treatment of
AML,” Dr. Thackray concluded.
Meeting abstracts are available on ASH’s website.
GlycoMimetics to Hold Post-ASH Meeting Briefing
in Boston on December 19
GlycoMimetics will hold a briefing for investors/analysts,
which will also be available via webcast, to review the GMI-1271
program with a focus on the AML clinical data presented at the ASH
Annual Meeting, at the Langham Hotel in Boston, December
19, at 7:30 a.m. EST. Dr. DeAngelo will present the
clinical data from the ASH oral presentation and respond to
questions from on-site participants.
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' first
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 antagonist, has been evaluated in a Phase 1/2
clinical trial as a potential treatment for AML and is currently
being evaluated in an ongoing Phase 1 clinical trial for the
treatment of multiple myeloma. The U.S. Food and Drug
Administration has granted GMI-1271 Breakthrough Therapy
designation for the treatment of adult AML patients with
relapsed/refractory disease. GlycoMimetics has also conducted
a Phase 1 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.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements regarding
the clinical development of GMI-1271, including the expected timing
of clinical trials 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 (SEC) on March 1, 2017, and other filings
GlycoMimetics 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.
References
1. Feldman EJ, Brandwein J, Stone R, et al. Phase III randomized
multicenter study of a humanized anti-CD33 monoclonal antibody,
lintuzumab, in combination with chemotherapy, versus chemotherapy
alone in patients with refractory or first-relapsed acute myeloid
leukemia. Journal of clinical oncology. 2005;23(18):4110-4116.
47.
2. Greenberg PL, Lee SJ, Advani R, et al. Mitoxantrone,
etoposide, and cytarabine with or without valspodar in patients
with relapsed or refractory acute myeloid leukemia and high-risk
myelodysplastic syndrome: a phase III trial (E2995). Journal of
clinical oncology. 2004;22(6):1078-1086
3. Foran JM, Sun Z, Claxton DF, et al. North American Leukemia,
Intergroup phase III randomized trial of single agent clofarabine
as induction and post-remission therapy, and decitabine as
maintenance therapy in newly-diagnosed acute myeloid leukemia in
older adults (age≥ 60 years): A trial of the ECOG-ACRIN Cancer
Research Group (E2906). Blood. 2015;126(23):217-217. 45.
4. Lancet JE, Cortes JE, Hogge DE, et al. Phase 2 trial of
CPX-351, a fixed 5:1 molar ratio of cytarabine/daunorubicin, vs
cytarabine/daunorubicin in older adults with untreated AML. Blood.
2014;123(21):3239-3246.
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version on businesswire.com: http://www.businesswire.com/news/home/20171212005492/en/
GlycoMimetics, Inc.Investor Contact:Shari Annes,
650-888-0902sannes@annesassociates.comorMedia Contact:Jamie
Lacey-Moreira, 410-299-3310jamielacey@presscommpr.com
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