TYME Technologies Inc. (NASDAQ:TYME) saw its shares plummet early Wednesday, on word the company will discontinue SM-88 with MPS in the Precision Promise trial in metastatic pancreatic cancer (mPDAC).
TYME announced the discontinuation of SM-88 with MPS in the Precision Promise trial in metastatic pancreatic cancer (mPDAC) upon learning from the trial sponsor, Pancreatic Cancer Action Network (PanCAN), that it terminated the arm due to futility compared to the control of standard of care chemotherapy in second-line mPDAC. Based on the information provided by PanCAN, the overall survival for SM-88 with MPS in monotherapy was lower compared to standard of care chemotherapies with either Gemcitabine and Abraxane or modified FOLFIRINOX.
The Precision Promise trial is an adaptive randomized Phase 2/3 trial in mPDAC for patients treated in both first-line and second-line therapies. SM-88 (racemetyrosine) with MPS (10 mg methoxsalen, 50 mg phenytoin, and 0.5 mg sirolimus) was the first therapy to join this trial and was being studied as a standalone monotherapy in second-line patients versus control arms of standard of care regimens of either Gemcitabine and Abraxane or modified FOLFIRINOX.
Said CEO Richie Cunningham, “Given pancreatic cancer’s high mortality rate, we wanted to make a difference in the lives of these patients. Our team understood that many efforts before us have failed, but based on SM-88’s prior activity and safety profile, we were hopeful we could provide an effective new option for those fighting against this devastating disease.”
TYME shares are down 20 cents, or 37.8% to 33 cents first thing Wednesday.