On May 26, 2021 GlycoMimetics, Inc. (Nasdaq: GLYC) reported that that clinicians at Washington University School of Medicine in St. Louis have dosed the first patient in an investigator-sponsored trial (IST) evaluating uproleselan as a prophylactic agent to reduce gastrointestinal (GI) toxicities associated with high-dose melphalan in autologous hematopoietic cell transplantation (auto-HCT) for multiple myeloma (MM) (Press release, GlycoMimetics, MAY 26, 2021, View Source [SID1234580614]). Dr. Keith Stockerl-Goldstein, M.D., Professor of Medicine, Division of Oncology, Section of Bone Marrow Transplantation, Washington University School of Medicine, is the clinical trial’s principal investigator.
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"GI side effects are the dose-limiting toxicities of high-dose melphalan in autologous hematopoietic stem-cell transplantation. Preclinical data have demonstrated a protective effect of uproleselan against mucosal damage and, in the GlycoMimetics Phase 2 trial reported at the American Society of Hematology (ASH) (Free ASH Whitepaper) meeting in 2018, uproleselan demonstrated the potential to mitigate severe mucositis in relapsed and refractory acute myeloid leukemia (AML) patients undergoing intensive chemotherapy," said Eric J. Feldman, M.D., GlycoMimetics’ Chief Medical Officer. "With this background, Washington University clinicians at Siteman Cancer Center will be the first to look closely at the potential of uproleselan to attenuate GI toxicities in multiple myeloma patients undergoing transplant. If this placebo-controlled study demonstrates positive improvements, we believe it will underscore the unique properties of our compound and the potential safety benefits of adding uproleselan to a range of other standard blood cancer therapies where toxicity and durability of response are concerns."
About the Phase 2 Study
The study led by Washington University is a Phase 2, single-center, randomized, double-blind, and placebo-controlled IST designed to evaluate whether prophylactic uproleselan plus standard of care (SOC) compared to placebo plus SOC can reduce diarrhea severity in patients receiving high-dose melphalan conditioning in preparation for auto-HCT in MM. Clinicians will observe for oral mucositis severity and other GI toxicities as secondary endpoints. Exploratory endpoints will also assess minimal residual disease at 100 days post-HCT; soluble E-selectin levels at pre-dose and post-conditioning time points; progression free survival; and overall survival.
Eligible patients undergoing first auto-HCT with melphalan conditioning (200mg/m2) for MM will be randomized in a 1:1 allocation to receive either prophylactic uproleselan plus SOC or placebo plus SOC. Randomization will be stratified by age ≥65 years and <65 years, due to increased frequency of GI toxicity in elderly populations. GlycoMimetics anticipates a data readout from the trial in mid-2022.
Siteman Cancer Center, based at Barnes-Jewish Hospital and Washington University School of Medicine, is a top-ranked National Cancer Institute (NCI)-designated Comprehensive Cancer Center and recently received the NCI’s highest possible rating of "Exceptional" for its research programs.
About Uproleselan
Discovered and developed by GlycoMimetics, uproleselan is an investigational, first-in-class, targeted antagonist of E-selectin. Uproleselan (yoo’ pro le’ sel an), currently in a comprehensive Phase 3 development program in AML, has received Breakthrough Therapy designation from the U.S. Food and Drug Administration and the Chinese Health authority for the treatment of adult AML patients with relapsed or refractory disease. Uproleselan is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance