GMI-1359 is a rationally-designed small molecule that antagonizes both E-selectin and a chemokine receptor known as CXCR4. Since E-selectin and CXCR4 are implicated in the retention of cancer cells in the bone and bone marrow, we believe that targeting both E-selectin and CXCR4 with a single compound could improve efficacy in the treatment of cancers that involve the bone.
We completed a Phase 1 randomized, double-blind, placebo-controlled, single-dose escalation trial of GMI-1359 in healthy volunteers. In this trial, volunteer participants received a single injection of either GMI-1359 or placebo, after which they were evaluated for safety, tolerability and PK. This trial was conducted at a single site in the United States. GMI-1359 was generally well tolerated in this trial, with no participants experiencing serious adverse events. A Phase 1b trial of GMI-1359 in HR+ breast cancer patients whose tumors have spread to bone is currently ongoing (NCT04197999). The trial, being conducted at Duke University, is evaluating safety, pharmacokinetics and pharmacodynamic markers of biologic activity in these patients. Interim results from this trial were reported at the AACR meeting in April 2021 showing clear evidence of on-target biological effects. This Phase 1b trial is expected to close by end of year 2021.
Additionally, the FDA awarded GMI-1359 a Rare Pediatric Disease designation and Orphan Drug review designation for the treatment of osteosarcoma.
GMI-1359 has not been approved for use by any health authority anywhere in the world.
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