Tyme Technologies, Inc. (NASDAQ:TYME) shares climbed around 19% Friday after the company presented updated data for its Phase 2 Study of TYME-88-Pancreatic Cancer at the ESMO GI 2019.
The New York-based drug firm reported In this poor prognosis population, SM-88 demonstrated median overall survival (OS) of 6.4 months as of last April.
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
According to Chief Medical Officer Guiseppe Del Priore, "We believe that these outcomes further justify advancing the development of SM-88. These survival results compare very favorably to the analysis of 19 prospective pancreatic cancer trials where the median reported survival after progressing on third-line therapy was 2.0 – 2.5 months1 based on reported historical trials."
TYME management will be hosting a conference call Tuesday for analysts and investors to discuss the data.
Tyme shares advanced two cents, or 1.4%, to $1.47
