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TYME and The Joseph Ahmed Foundation Announce Initiation of the HopES Phase II Trial Evaluating the Potential Benefits of SM-88 for Patients with High-Risk Sarcomas
NEW YORK, May 23, 2019 (GLOBE NEWSWIRE) -- Tyme Technologies, Inc. (NASDAQ: TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs™), announced the initiation of the HopES trial conducted in partnership with The Joseph Ahmed Foundation to better understand and help manage high-risk sarcomas which are ultra-rare cancers with high unmet medical need. "There is an urgent need for more effective treatment options for patients with high-risk sarcomas, including Ewing’s sarcoma,” said Sant Chawla, M.D., Director of the Sarcoma Oncology Research Center, Santa Monica, CA and lead investigator for the HopES trial. "I was encouraged by the initial clinical trial data for SM-88 in metastatic sarcomas. This study has the potential to provide a new treatment option for patients with Ewing’s sarcoma who do not reach complete remission with first line treatment and patients with other sarcomas after progression. We are excited to partner with The Joseph Ahmed Foundation and TYME to further advance the science of cancer metabolism, research and education in these rare cancers so that patients can have better, safer options." The HopES trial is a prospective open-label Phase II trial evaluating the efficacy and safety of SM-88 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 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. The Joseph Ahmed Foundation is providing funding and patient support for this investigator-initiated HopES Phase II trial of SM-88 in patients with previously-treated metastatic sarcomas. The primary objectives are to measure 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 v1.1), and incidence of treatment-emergent adverse events. Click here to learn more: https://clinicaltrials.gov/ct2/results?term=sarcoma+sm-88&Search=Search. "The partnership with The Joseph Ahmed Foundation underscores our commitment to advance the understanding of rare cancers, and continue advancing our unique scientific approach through cancer metabolism-based therapies that have the potential to change the course of care for patients with high-risk sarcomas," said Giuseppe Del Priore, M.D., M.P.H., Chief Medical Officer at Tyme Technologies. "We look forward to the findings of the HopES trial and to continue strengthening our research efforts to provide transformative options for patients with high-risk sarcomas and other metastatic cancers." About Sarcomas and Ewing’s Sarcoma Sarcomas are rare cancers in adults, but rather prevalent in children. All sarcomas represent approximately 12,0001 new cases annually in the U.S. alone. It is made up of many “subtypes” because it can arise from a variety of tissue structures (nerves, muscles, joints, bone, fat, blood vessels – collectively referred to as the body’s “connective tissues”). Because these tissues are found everywhere on the body, Sarcomas can arise anywhere. The most frequent location are the limbs since this is where he majority of the body’s connective tissue resides. They are commonly hidden deep in the body, so sarcoma is often diagnosed when it has already become too large to expect a hope of being cured. Ewing sarcoma is a type of tumor that forms in the bone or soft tissue. It is considered a rare type of cancer that is often overlooked and receives minimal recognition and research funding. Although, Ewing’s sarcoma is considered a pediatric cancer (accounts for 30% of bone cancers in children) it is also 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 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 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. The JAF’s mission is to provide resources for research programs and support services through fundraising, philanthropic donations, corporate sponsorship and grants. The 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 About Tyme Technologies Forward-Looking Statements/Disclosure Notice In addition to historical information, this press release contains forward-looking statements under the Private Securities Litigation Reform Act that involve substantial risks and uncertainties. Such forward-looking statements within this press release include, without limitation, statements regarding our drug candidate SM-88 and its clinical potential and non-toxic safety profiles, our drug development plans and strategies, ongoing and planned clinical trials, preliminary data results and the therapeutic design and mechanisms of our drug candidates; and readers can identify forward-looking statements by sentences or passages involving the use of terms such “believes,” “expects,” “hopes,” “may,” “will,” “plan,” “intends,” “estimates,” “could,” “should,” “would,” “continue,” “seeks,” or “anticipates,” and similar words (including their use in the negative) or by discussions of future matters such as the development and potential commercialization of our lead drug candidate and of other new products, expected releases of interim or final data from our clinical trials, possible collaborations, the timing, scope and objectives of our ongoing and planned clinical trials and other statements that are not historical. The forward-looking statements contained in this press release are based on management’s current expectations, which are subject to uncertainty, risks and changes in circumstances that are difficult to predict and many of which are outside of TYME’s control. These statements involve known and unknown risks, uncertainties and other factors which may cause the TYME’s actual results, performance or achievements to be materially different from any historical results and future results, performances or achievements expressed or implied by the forward-looking statements. These risks and uncertainties include, but are not limited to, that the information is of a preliminary nature and may be subject to change; uncertainties inherent in research and development, including the ability to achieve clinical study start and completion dates; the possibility of unfavorable study results, including unfavorable new clinical data and additional analyses of existing data; risks associated with early, initial data, including the risk that the final Phase II data may differ from prior study data or preliminary Phase II data; final results of additional clinical trials that may be different from the preliminary data analysis and may not support further clinical development; that past reported data are not necessarily predictive of future patient or clinical data outcomes; whether and when any applications or other submissions for SM-88 may be filed with regulatory authorities; whether and when regulatory authorities may approve any applications or submissions; decisions by regulatory authorities regarding labeling and other matters that could affect commercial availability of SM-88; competitive developments; and the factors described in the section captioned “Risk Factors” of TYME’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission on June 13, 2018, as well as subsequent reports we file from time to time with the U.S. Securities and Exchange Commission (available at www.sec.gov). The information contained in this press release is as of its release date and TYME assumes no obligation to update forward-looking statements contained in this release as a result of future events or developments. 1https://www.cancer.org/cancer/soft-tissue-sarcoma/about/key-statistics.html Contact Ashley R. Robinson Source: Tyme Technologies, Inc.
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