On August 11, 2020 Tyme Technologies, Inc. (NASDAQ: TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs), reported 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 (Press release, TYME, AUG 11, 2020, View Source [SID1234563447]).
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"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.
About Sarcomas and Ewing’s Sarcoma
Sarcomas are rare cancers in adults but are more common in children. There are approximately 12,0001 new sarcoma cases annually in the U.S. alone. There are many "subtypes" of sarcoma, as it can arise in many tissue structures throughout the body (nerves, muscles, joints, bone, fat, blood vessels – collectively referred to as the body’s "connective tissues"). Sarcomas are most frequently found in the limbs, as this is where the majority of the body’s connective tissues are found but can also present within the sites of more "common" cancers (e.g., breast sarcoma, stomach sarcoma, lung sarcoma, ovarian sarcoma, etc.). Sarcoma cancers often grow hidden deep in the body and are often diagnosed when the tumor size limits effective treatment options.
Ewing’s sarcoma is a primary bone cancer within a group of cancers known collectively as the Ewing’s sarcoma family of tumors. Ewing’s sarcoma is a type of tumor that forms in the bone or soft tissue. It is a rare type of cancer that is often overlooked and receives minimal recognition and research funding. Although Ewing’s sarcoma is typically a pediatric cancer, (it accounts for 30% of bone cancers in children), it can also be found in adults. The most commonly affected areas include the pelvis, thigh, lower leg, upper arm, and chest wall.
About SM-88
SM-88 is an oral investigational modified proprietary tyrosine derivative that is believed 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. SM-88 is an investigational therapy that is not approved for any indication in any disease. Learn more.
About the Joseph Ahmed Foundation
The Joseph Ahmed Foundation (JAF) is a 501(c)(3) non-profit organization that was founded in 2016 by the family of Joseph Ahmed, who lost his courageous battle with Ewing’s Sarcoma eight months after his diagnosis on September 1, 2014, at the age of 16. Through their tragic loss and grief, Joseph’s loved ones established the Joseph Ahmed Foundation which is dedicated to raising public awareness for the importance of early detection of the disease, and the urgent need of funding for research and development of innovative treatment and therapies to treat Ewing’s Sarcoma and other forms of pediatric cancer. JAF’s mission is to provide resources for research programs and support services through fundraising, philanthropic donations, corporate sponsorship and grants. JAF is comprised of passionate board members and volunteers who all share the same vision, finding a cure. The foundation can be reached at 212-867-8667. The global website is www.thejosephahmedfoundation.org