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MEI Pharma (Nasdaq: MEIP) is a San Diego-based pharmaceutical company focused on leveraging its extensive development and oncology expertise to identify and advance new therapies for cancer. Our approach to building our pipeline is to license promising cancer agents and create value in programs through development and commercialization, or strategic partnerships, as appropriate. Our portfolio contains four clinical-stage drug candidates, including one candidate in an ongoing global registration trial and another candidate that is anticipated to advance into a registration trial this year. Our drug candidate pipeline includes: Pracinostat, an oral HDAC inhibitor that is in a Phase 3 pivotal study in combination with azacitidine for the treatment of acute myeloid leukemia. Pracinostat is also being evaluated in a clinical study in patients with myelodysplastic syndrome. Pracinostat is licensed to Helsinn Healthcare SA, a Swiss pharmaceutical corporation. ME-401, a selective oral inhibitor of phosphatidylinositol 3-kinase (“PI3K”) delta. ME-401 is anticipated to progress into a single-agent registration study in 2018 for the treatment of adults with relapsed or refractory follicular lymphoma. Voruciclib, an orally administered and selective cyclin-dependent kinase (“CDK”) inhibitor differentiated by its potent in vitro inhibition of CDK9 in addition to CDK6, 4 and 1. Initiation of a Phase I dose-escalation study in patients with relapsed and/or refractory B-cell malignancies after failure of prior standard therapies is scheduled to being in the second calendar quarter of 2018. ME-344, a novel and tumor selective, isoflavone-derived mitochondrial inhibitor drug candidate, has demonstrated evidence of single-agent activity against refractory solid tumors in a Phase I study. In preclinical studies, tumor cells treated with ME-344 resulted in a rapid loss of ATP and cancer cell death. It is currently being evaluated in an investigator-initiated study in combination with the VEGF inhibitor bevacizumab (marketed as Avastin®) in patients with HER2 negative breast cancer.
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