An emerging biotech firm which develops cancer metabolism-based therapies, Tyme Technologies Inc. made an announcement that its multicenter open-label Phase 2 TYME-88-Panc study analyzing SM-88 as an oral monotherapy in patients who have advanced pancreatic cancer continues to score encouraging results & a nicely-tolerated safety profile. At the European Society of Medical Oncology 21st World Congress on Gastrointestinal Cancer, the data from the TYME-88-Panc study was presented on the 4th of July in Spain.
The Managing Director, as well as, Chief Medical Officer at Tyme Technologies, Giuseppe Del Priore stated that we believe that these results additionally justify expanding the development of SM-88. These survival outcomes compare very positively to the analysis of nineteen prospective pancreatic cancer trials where the median reported survival after progressing on 3rd line therapy was 2.0 to 2.5 months based on reported historical trials. Since there are no effective options for the treatment of this patient population, we intend to move forward with our SM-88 pivotal trial in pancreatic cancer. We are more and more encouraged that SM-88 has the potential to be a new approach for treating late-stage pancreatic patients.
Updated outcomes from the continuing multicenter open-label Phase 2 TYME-88-Panc study included 49 heavily pretreated patients with radiographically progressive metastatic pancreatic cancer who had significant disease-related illness before they received TYME’s investigational agent SM-88. Over 80 percent of patients had received at least 2 prior lines of therapy. Out of the 49 patients, 38 patients were evaluable for effectiveness, as defined in the procedure. TYME-88-Panc is a study of 2 parts in which Part 1 was to determine ideal dosing and evaluate if early clinical benefit supported further development of SM-88 in pancreatic cancer. This research is being performed under a TYME IND with input from the Food and Drug Administration prior to study initiation. According to the findings, the average overall survival of evaluable patients was 6.4 months.