TYME Announces Outcome of Interim Futility Review for HopES Sarcoma Phase II Study

Tyme Technologies, Inc. (NASDAQ: TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs), announced today a positive outcome of an interim futility review for the HopES Sarcoma Phase II clinical trial that is evaluating TYME’s lead cancer metabolism-based candidate, SM-88, as a potential oral treatment for patients with Ewing’s Sarcoma and other high-risk sarcomas.

“It is evident that the salvage cohort will pass the futility test and meet the criteria for expansion,” said Sant Chawla, M.D., founder of the Sarcoma Oncology Center, Santa Monica, CA and principal investigator for the HopES Sarcoma trial.

The interim futility review was completed in late July and, based on the analysis of the data and recommendations of Dr. Sant Chawla, the study will proceed with the current trial design as planned. The next major milestone in the HopES Sarcoma trial is expected in calendar year 2021. Sarcomas represents a great unmet medical need and significant opportunity for all stakeholders. There are more than 12,000 patients diagnosed each year without meaningful treatment options.

“We are pleased to have reached this important point in the HopES Sarcoma trial and now await the final results of the trial to determine the potential of oral SM-88 in high-risk sarcomas in an effort to improve the lives of these patients with, what we believe could be, a better safer approach,” said Giuseppe Del Priore, M.D., M.P.H., Chief Medical Officer at TYME. “To date, SM-88 has demonstrated encouraging tumor responses in 15 different cancers across four separate studies with minimal serious grade 3 or higher adverse events.”

The HopES Sarcoma trial is a prospective open-label Phase II trial evaluating the efficacy and safety of SM-88, with the conditioning agents methoxsalen, phenytoin and sirolimus, in two cohorts of patients. Up to 24 evaluable patients (12 per cohort) will be enrolled. The first cohort will evaluate oral SM-88 as maintenance monotherapy following standard primary or palliative treatments for Ewing's sarcoma patients with a high risk of relapse or disease progression. The second cohort will determine the clinical benefits of SM-88 as salvage monotherapy for patients with clinically advanced sarcomas. Patient dosing began in January 2020. The Joseph Ahmed Foundation is providing funding and patient support for this investigator-initiated Phase II (HopES) trial of SM-88 in patients with previously treated metastatic sarcoma, sponsored by the Sarcoma Oncology Research Center. The primary objectives are to measure efficacy events, including overall response, stable disease and progression free survival. Secondary objectives include duration of response, overall survival, clinical benefit rate using response evaluation criteria in solid tumors (RECIST 1.1), and incidence of treatment-emergent adverse events. Learn more at TYMETRIALS.com.