GlycoMimetics Announces High Overall Response Rates, Low Induction Mortality, Promising Initial Survival Outcomes, and Supportive Biomarker Data from Phase 1/2 Trial of GMI-1271 in AML
- Company to provide update and host conference call today on clinical data to be presented at 2017 ASCO and EHA 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
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.
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
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.
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
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.
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.
Presenter:
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.
Presenter:
The ASCO Annual Meeting 2017 takes place from
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.
Presenter:
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.
Presenter:
The 22nd
About
GlycoMimetics is a clinical-stage biotechnology company focused on
cancer and sickle cell disease.
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
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