GlycoMimetics is developing GMI-1271, a small molecule E-Selectin antagonist, as an adjunct treatment to standard of care chemotherapy for hematologic malignancies, initially targeting AML. GlycoMimetics is also studying GMI-1271 in patients with multiple myeloma. By blocking E-selectin, GMI-1271 also may protect normal blood-producing cells, and reduce the toxic side effects of chemotherapy such as low white blood cell counts that make some patients more prone to infections.
GMI-1271 has been tested in healthy volunteers and is now being tested in individuals with AML via a Phase 1/2 clinical trial. Results of preclinical studies were presented at annual meetings of the American Society of Hematology (ASH) and at the American Association for Cancer Researchers (AACR) Annual Meeting. GMI-1271 has not been approved for use by any worldwide health authority.
GMI-1271 has received Fast Track designation from the U.S. Food and Drug Administration (FDA), which may lead to speedier delivery to people living with AML if the treatment is found to be effective. The FDA has also granted a Breakthrough Therapy designation for GMI-1271 for adults with relapsed/refractory AML. The European Union granted Orphan Drug Designation for GMI-1271 in AML, a designation the FDA granted the drug candidate in 2015. GMI-1271 has not been approved for use by any worldwide health authority.
Interim data reports on the on-going Phase 1/2 trial were presented at EHA in June 2016 and at ASH in December 2016, showing high remission rates and a good safety profile in the study at that point. Further results were also presented at the meetings of the American Society of Clinical Oncology and EHA in June 2017, and at the ASH Meeting in December 2017:
“These 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.”
About the Phase 1/2 Trial in AML
The study is a multicenter, open-label Phase 1/2 trial using GMI-1271 in combination with standard chemotherapy in individuals with AML. The investigational agent was given throughout the chemotherapy treatment period. Some additional bone marrow and blood samples were obtained during routine bone marrow assessments, to further inform study doctors about drug activity.
About the Current Trial in Multiple Myeloma
The newly initiated multi-center, open-label dose escalation trial, which has begun in Ireland, will measure the efficacy, safety and pharmacokinetics of GMI-1271 in combination with chemotherapy among patients who have been diagnosed with multiple myeloma and have not responded well to standard chemotherapy. The company anticipates enrolling 24 participants in the trial.
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