TYME Provides Updated Data on TYME-88-Panc Phase II Study

Tyme Technologies (NASDAQ:TYME) has provided an update on its open-label Phase 2 TYME-88-Panc study.

As quoted in the press release:

The data from the TYME-88-Panc study were presented at the European Society of Medical Oncology 21st World Congress on Gastrointestinal Cancer(ESMO GI) on July 4, 2019 in Barcelona, Spain.

“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,” said Giuseppe Del Priore, M.D., M.P.H., Chief Medical Officer at Tyme Technologies. “Given that there are no effective options to treat this patient population, we plan to move forward with our SM-88 pivotal trial in pancreatic cancer. We are increasingly encouraged that SM-88 has the potential to be a new treatment approach for late-stage pancreatic patients.”

Updated results from the ongoing multicenter open-label Phase II TYME-88-Panc study (Abstract #160) involved 49 heavily pretreated patients with radiographically progressive metastatic pancreatic cancer who had significant disease related morbidity before receiving TYME’s investigational agent SM-88. More than 80% of patients had received at least two prior lines of therapy. Of the 49 patients, 38 patients were evaluable for efficacy, as defined in the protocol. TYME-88-Panc is a two-part study in which Part 1 was intended to determine optimal dosing and assess if early clinical benefit supported further development of SM-88 in pancreatic cancer. This study is being performed under a TYME IND with input from the FDA prior to study initiation.

In this study, based on information available as of April 25, 2019, the median overall survival of evaluable patients (38 of 49) was 6.4 months. Certain efficacy indicators correlated with greater OS, including achieving SD or better and decreases in CTCs.

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