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The company’s TYME-99-Panc trial will evaluate its candidate SM-88 in patients with metastatic pancreatic cancer.
Tyme Technologies (NASDAQ:TYME) has announced the start of the pivotal stage of its TYME-99-Panc trial of its lead CMBT candidate, SM-88, to treat patients with metastatic pancreatic cancer.
As quoted in the press release:
CMBTs are proprietary investigational compounds that are believed to disrupt cancer cells’ protein synthesis, leading to a breakdown of the cancer’s key defenses and cell death. In clinical trials, SM-88 has demonstrated encouraging tumor responses across 15 different cancers, including pancreatic, prostate, sarcoma, breast, lung, and lymphoma cancers with minimal serious grade 3 or higher adverse events.
“We believe that targeting cancer’s metabolism by disrupting protein synthesis has advantages over existing treatment approaches for both efficacy and safety,” said Giuseppe Del Priore, M.D., Chief Medical Officer at TYME. “In clinical studies to date, SM-88 had encouraging efficacy results and appears to be well-tolerated. The pancreatic phase II data demonstrated that new efficacy indicators, including achieving at least stable disease and decreasing circulating tumor cells following treatment with SM-88 correlate with greater overall survival in metastatic pancreatic cancer patients.”
Based on the encouraging results demonstrated in the Phase II portion of the TYME-88-Panc study of SM-88, TYME has designed the pivotal stage of the TYME-88-Panc study as a multi-center randomized (1:1), controlled pivotal trial that will evaluate the efficacy and safety of SM-88 used with MPS (methoxsalen, phenytoin, sirolimus) in patients with metastatic adenocarcinoma of the pancreas whose disease has progressed or recurred and have received two lines of prior systemic therapy. Approximately 250 patients will be randomized to receive a 920 mg dose of SM-88 with MPS daily (Arm A n=125) or one of three pre-defined single agent therapies (Arm B n=125). Patients will be treated until there is unacceptable toxicity or disease progression. The primary endpoint is overall survival (OS). Key secondary endpoints include progression free survival (PFS), clinical benefit response rate (CBR), defined as patients achieving stable disease or better, circulating tumor cells (CTCs) and quality of life (QOL). The study will include leading pancreatic cancer research sites across the United States. Click here to learn more.