TYME Technologies Announces New Collaboration with NYU Langone to Advance TYME’s Cancer Metabolism-Based Therapy, SM-88


NEW YORK, July 29, 2019 (GLOBE NEWSWIRE) -- Tyme Technologies, Inc. (NASDAQ: TYME), an emerging biotechnology company, announced a new research collaboration with NYU Langone Health to advance the development of innovative treatments for patients with metastatic cancers, including pancreatic cancer. The collaboration will leverage NYU Langone’s state-of-the-art technologies to help inform the development of clinical therapies, focusing on identifying potential future biomarkers or combination approaches to treat cancer.

“We are excited to collaborate on this new effort to help uncover key findings about how specific biomarkers may help slow the development of certain cancer types,” said Diane Simeone, MD, Director of the Pancreatic Cancer Center at NYU Langone Health’s Perlmutter Cancer Center and Lead Principle Investigator for the Pancreatic Cancer Network’s Precision PromiseSM trials. “We believe our translational research can help affect future development of SM-88 and broaden our understanding of this novel approach by targeting cancer metabolism.”

The broad collaboration will examine the effects of SM-88 and each of the components of MPS (methoxsalen, phenytoin, and sirolimus) on primary pancreatic cancer cell lines, patient-derived pancreatic cancer organoids as well as specialized mouse xenograft models.  

The studies will explore the impact of SM-88 on clinical models, including viability, general pharmacodynamics, genomic and RNA transcription analysis, and detailed impact on cancer metabolism. In addition, the specialized mouse tumor xenograft experiments should provide immunohistochemical signals of SM-88 effects and comprehensive immunomodulatory impact of the tumor microenvironment. This research will evaluate the potential of SM-88 in combination with standard approved cancer therapies, with a goal to identify optimal synergistic combinations with SM-88 for future development in metastatic cancers.  

“TYME is focused on advancing SM-88 for cancer patients where the unmet medical need is greatest,” said Jonathan Eckard, Ph.D. and Chief Business Officer for Tyme Technologies, Inc. “We are very excited to work on this project with someone as accomplished as Dr. Simeone both in research, and in the clinic as the principle investigator in Precision Promise.”   

About SM-88
SM-88 is an oral investigational modified 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 Tyme Technologies
TYME Technologies, Inc., is an emerging biotechnology company developing cancer metabolism-based therapeutics that are intended to be broadly effective across tumor types and have low toxicity profiles. Unlike targeted therapies that attempt to regulate specific mutations within cancer, the Company’s therapeutic approach is designed to take advantage of a cancer cell’s innate metabolic weaknesses to compromise its defenses, leading to cell death through oxidative stress and exposure to the body’s natural immune system. For more information, visit www.tymeinc.com. Follow us on social media: @tyme_IncLinkedInInstagramFacebook and YouTube.

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 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 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 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 12, 2019, 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.

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