NEW YORK, April 15, 2019 (GLOBE NEWSWIRE) -- Tyme Technologies, Inc. TYME, an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs™), announced today that the United States Adopted Name (USAN) Council recently granted "racemetyrosine" as the generic name for SM-88, TYME's lead pipeline candidate.
The purpose of the United States Adopted Names Council is to serve the health professions in the United States by selecting simple, informative, and unique generic names for therapies by establishing logical nomenclature classifications based on pharmacological and/or chemical relationships.
"The USAN approval of racemetyrosine as the generic name for SM-88 is another step for continued advancement of SM-88," said Giuseppe Del Priore, M.D., M.P.H., Chief Medical Officer at Tyme Technologies. "We believe by leveraging the existing trial infrastructure from our TYME-88-Panc study that we are well positioned to advance SM-88 as a new treatment option, as quickly as possible, for patients with third-line pancreatic cancer."
SM-88 is an investigational therapy that is not approved for any disease indication.
TYME has announced that it is in the process of finalizing a randomized pivotal trial protocol amendment for use of SM-88 in third-line pancreatic cancer. In addition, SM-88, will be an experimental option in the Pancreatic Cancer Action Network Precision PromiseSM pivotal adaptive design study.
About SM-88 (racemetyrosine)
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 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_Inc, LinkedIn, Instagram, Facebook 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 "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.
Contact
Ashley R. Robinson
LifeSci Advisors, LLC
617-535-7742
arr@lifesciadvisors.com
Source: Tyme Technologies, Inc.
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