TYME to Initiate Pivotal Trials for SM-88 in Patients with Metastatic Pancreatic Cancer
Tyme Technologies, Inc. (NASDAQ: TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs™), announced today that the United States Adopted Name (USAN) Council recently granted “racemetyrosine” as the generic name for SM-88, TYME’s lead pipeline candidate.
The purpose of the United States Adopted Names Council is to serve the health professions in the United States by selecting simple, informative, and unique generic names for therapies by establishing logical nomenclature classifications based on pharmacological and/or chemical relationships.
“The USAN approval of racemetyrosine as the generic name for SM-88 is another step for continued advancement of SM-88,” said Giuseppe Del Priore, M.D., M.P.H., Chief Medical Officer at Tyme Technologies. “We believe by leveraging the existing trial infrastructure from our TYME-88-Panc study that we are well positioned to advance SM-88 as a new treatment option, as quickly as possible, for patients with third-line pancreatic cancer.”
SM-88 is an investigational therapy that is not approved for any disease indication.
TYME has announced that it is in the process of finalizing a randomized pivotal trial protocol amendment for use of SM-88 in third-line pancreatic cancer. In addition, SM-88, will be an experimental option in the Pancreatic Cancer Action Network Precision PromiseSM pivotal adaptive design study.
About SM-88 (racemetyrosine)
SM-88 is an investigational dysfunctional proprietary tyrosine derivative that is hypothesized to interrupt the metabolic processes of cancer cells by breaking down the cells’ key defenses and leading to cell death through oxidative stress and exposure to the body’s natural immune system. Clinical trial data have shown that SM-88 has demonstrated encouraging tumor responses across 15 different cancers, including pancreatic, lung, breast, prostate and sarcoma cancers with minimal serious grade 3 or higher adverse events.
About Tyme Technologies
Tyme Technologies, Inc., is an emerging biotechnology company developing cancer metabolism-based therapeutics that are intended to be broadly effective across tumor types and have low toxicity profiles. Unlike targeted therapies that attempt to regulate specific mutations within cancer, the Company’s therapeutic approach is designed to take advantage of a cancer cell’s innate metabolic weaknesses to compromise its defenses, leading to cell death through oxidative stress and exposure to the body’s natural immune system. For more information, visit www.tymeinc.com. Follow us on social media: @tyme_Inc, LinkedIn, Instagram, Facebook and YouTube.