CMBTs are proprietary investigational compounds that are believed to disrupt cancer cells' protein synthesis, leading to a breakdown of the cancer's key defenses and cell death.
'The partnership with
'There are significant knowledge gaps about high-risk sarcomas, such as Ewing's sarcoma, including the role of cancer metabolism-based medicines, and the related outcomes for patients,' said
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 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.
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
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.
About the
About
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 candidates including SM-88 and TYME-18 and their 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 as '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 cost of 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 Company'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 the cost and outcomes of research and development, including the cost and availability of acceptable-quality clinical supply and the ability to achieve adequate clinical study design and 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 data from any clinical trials may differ from prior or preliminary study 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; the ability of TYME and its collaborators to develop and realize collaborative synergies; competitive developments and the factors described in the section captioned 'Risk Factors' of TYME's Annual Report on Form 10-K filed with the
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.
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