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Monday, April 8, 2019

Tyme Technologies says SM-88 first in-human study published in IND

Tyme Technologies announced that the results of its first human study, completed as of September 15, 2017 and designed to evaluate the safety, tolerability and efficacy of SM-88 in patients with advanced metastatic cancers, was published online on March 30th 2019 in the peer-reviewed journal Investigational New Drugs. The article, titled “A first-in-human study of the novel metabolism-based anti-cancer agent SM-88 in subjects with advanced metastatic cancer,” is available online. Based on these proof-of-concept clinical findings, TYME is developing new approaches, including SM-88, that target cancer metabolism. As metabolic changes in tumor cells are nearly universal, TYME believes that targeting these mechanisms creates the possibility of delivering potent therapeutic benefit across a broad spectrum of solid tumors and blood cancers. The SM-88 first human study was a TYME-sponsored, open-label, single-center first in human study of 30 patients with metastatic cancers who had failed or refused all available therapeutic options. In this study, SM-88 was used with low doses of melanin, melanotan 2, phenytoin, and sirolimus. Based on results from the study, clinical researchers observed that patients reached a median overall survival of 29.8 months and 13 months of progression free survival without additional therapy. 33% of patients achieved RECIST complete response and partial response with median time to best response of greater than 3 months. 57% of patients achieved RECIST stable disease with a median duration of 11 months.

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