On January 26, 2022 TYME Technologies, Inc. (Nasdaq: TYME) (the Company or TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs), reported 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 (Press release, TYME, JAN 26, 2022, View Source [SID1234607413]). 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.
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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.
"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," said Richie Cunningham, Chief Executive Officer of TYME. "I want to express my sincerest appreciation to the patients, their loved ones, the researchers, and the principal investigators involved in this trial, as well as thank PanCAN and Precision Promise for their passionate dedication to exploring new treatment options for pancreatic cancer patients."
"Given our prior promising results with SM-88 plus MPS in a subset of patients in second-line pancreatic cancer1, we are disappointed that we couldn’t make an impact in this very difficult to treat population. We will work with PanCAN and Precision Promise leadership to further analyze the data with the SM-88 arm, as it becomes available," said Dr. Jan M. Van Tornout, MD, MSC, Acting Chief Medical Officer of TYME.
TYME remains committed to advancing its current pipeline and the continued research and development of SM-88.