GlycoMimetics Presents Updated Data from Ongoing Phase 1/2 Clinical Trial of GMI-1271 in Patients with Acute Myeloid Leukemia at ASCO 2017 Annual Meeting
- Remission rates continue to be higher than historical controls and induction-related mortality continues to be lower than historical controls
- GMI-1271 continues to be well tolerated in combination with induction chemotherapy
- 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 value=.004)
- Initial duration of response data is encouraging
"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,"
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 months.
- Remissions were durable enough to allow 9 patients to receive stem cell transplants.
- 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 AML.
- 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
The ASCO Annual Meeting is taking place from
Data from the Phase 1/2 trial were submitted to the
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
This press release contains forward-looking statements regarding
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