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'The second quarter was quite productive as we noted strong enrollment in our company-sponsored pivotal trial of uproleselan in relapsed/refractory AML. Though we did see a slow down early in the COVID crisis, we were pleased to see enrollment pick back up later in the quarter. This was an important achievement in the face of the COVID-19 pandemic, and we are able to maintain prior guidance that we expect to complete enrollment in the second half of 2021. Also important were new data from a post hoc analysis of the rivipansel Phase 3 study that showed that patients treated with rivipansel within approximately 26 hours of the onset of pain in their crisis experienced statistically significant improvements in the primary efficacy endpoint of time to readiness for discharge compared to placebo. These data provide a foundation, we believe, for us to discuss with the
About Uproleselan (GMI-1271)
Discovered and developed by
About GMI-1687
GMI-1687 is a rationally designed, innovative antagonist of E-selectin that is potentially suitable for subcutaneous (SC) administration. When given by SC injection in preclinical models, GMI-1687 has been observed to have equivalent activity to uproleselan, but at an approximately 1,000-fold lower dose.
About Rivipansel
Rivipansel, a glycomimetic drug candidate that binds to all three members of the selectin family (E-, P- and L-selectin), was
About GMI-1359
GMI-1359 is designed to simultaneously inhibit both E-selectin and CXCR4. E-selectin and CXCR4 are both adhesion molecules involved in tumor trafficking and metastatic spread. Preclinical studies indicate that targeting both E-selectin and CXCR4 with a single compound could improve efficacy in the treatment of cancers that involve the bone marrow such as AML and multiple myeloma or in solid tumors that metastasize to the bone, such as prostate cancer and breast cancer, as well as in osteosarcoma, a rare pediatric tumor. GMI-1359 has completed a Phase 1 clinical trial in healthy volunteers. The Duke University Phase 1b clinical study in breast cancer patients is designed to enable investigators to identify an effective dose of the drug candidate and to generate initial biomarker data around the drug's activity. GMI-1359 has received Orphan Drug Designation and Rare Pediatric Disease Designation from the FDA for the treatment of osteosarcoma, a rare cancer affecting about 900 adolescents a year in
About
Forward-Looking Statements
This press release contains forward-looking statements regarding the Company's strategy and the clinical development and potential utility, benefits and impact of its drug candidates. These forward-looking statements include those relating to the planned preclinical research and clinical development of the Company's product candidates, including expectations with regard to the enrollment of patients in its ongoing Phase 3 clinical trial of uproleselan and the potential impact of the ongoing global COVID-19 pandemic on the Company's operations, and the Company's plans for discussing data from the Phase 3 clinical trial of rivipansel with the FDA. Actual results may differ materially from those expressed in or implied by these forward-looking statements. Forward-looking statements speak only as of the date of this release, and
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