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Sunday, July 7, 2019

TYME Updates at ESMO GI 2019 from Pancreatic Cancer Phase 2 Study

  • In this poor prognosis population, SM-88 demonstrated median overall survival (OS) of 6.4 months as of April 25, 2019
  • Efficacy indicators showed strong correlation with greater overall survival (OS). These indicators included achieving stable disease (SD) or better and decreases in circulating tumor cells (CTCs)
  • Patients who achieved SD or better had a statistically significant (p=0.02) improvement in survival with a 92% reduction in risk of death
  • Patients who achieved at least an 80% reduction in CTC burden demonstrated a 60% decrease in risk of death
  • The study supports SM-88’s well-tolerated safety profile, with only 4% of patients having a serious adverse event (SAE) that was deemed to be at least possibly related to SM-88
  • Based on these results, TYME plans to initiate a randomized pivotal trial for use of SM-88 in patients with pancreatic cancer in Q3’2019

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