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Pancreatic Cancer Expected to be the Second Leading Cause of Cancer-Related Death in the U.S. by 20201
TYME’s oral SM-88 represents a new approach designed to selectively disrupt protein synthesis in cancers - demonstrated responses in 15 different cancer types across four separate studies
Data presented at ESMO GI 2019 from TYME-88-PANC Phase II study demonstrated encouraging overall survival trends in patients with metastatic pancreatic cancer
TYME Expects Enrollment of Patients in the Pivotal Stage of TYME-88-Panc Trial to Evaluate Oral SM-88 for Third-Line Treatment of Patients with Metastatic Pancreatic Cancer by Year-End
NEW YORK, Nov. 25, 2019 (GLOBE NEWSWIRE) -- Tyme Technologies, Inc. (TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs™), today announced it will ring the Nasdaq Opening Bell on Wednesday, November 27, to honor the many stakeholders who are committed to finding a cure for patients with pancreatic cancer during Pancreatic Cancer Awareness Month. TYME will be joined by employees, oncologists, researchers and representatives of leading patient advocacy organizations for pancreatic cancer, namely the Pancreatic Cancer Action Network (PanCAN) and the Lustgarten Foundation.
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. In clinical trials, SM-88 has demonstrated encouraging tumor responses across 15 different cancers, including pancreatic, prostate, sarcoma, breast, lung, and lymphoma cancers with minimal serious grade 3 or higher adverse events.
"Our ultimate goal is to transform lives and give hope to people suffering from pancreatic cancer every single day," said Steve Hoffman, CEO of TYME. “We are committed to execute on our strategy of investing in the science of next-generation CMBTs to create disease-altering medicines for patients with metastatic cancers. Moreover, we are excited about the potential of SM-88 as a first-in-class cancer metabolism-based therapy and are looking forward to evaluating this promising new approach in our new pivotal study."
TYME has launched the pivotal stage of the TYME-88-Panc study designed as a multi-center randomized (1:1), controlled pivotal trial that will evaluate the efficacy and safety of SM-88 used with MPS (methoxsalen, phenytoin, sirolimus) in patients with metastatic adenocarcinoma of the pancreas whose disease has progressed or recurred and have received two lines of prior systemic therapy. Approximately 250 patients will be randomized to receive 920 mg of SM-88 with MPS (Arm A n=125) or one of three pre-defined single agent therapies (Arm B n=125). Patients will be treated until there is unacceptable toxicity, disease progression or if any treatment discontinuation criteria are met. The primary endpoint is overall survival (OS). Key exploratory endpoints include progression free survival (PFS), clinical benefit response rate (CBR), defined as patients achieving stable disease or better, circulating tumor cells (CTCs) and quality of life (QOL). The study will include leading pancreatic cancer research sites across the United States. Click here to learn more.
Patients and physicians can access www.TYMETRIALS.com for more information about ongoing SM-88 clinical trials. SM-88 is not approved for the treatment of patients with any disease condition.
About Advanced Pancreatic Cancer
Advanced pancreatic cancer is a difficult-to-treat cancer with the lowest survival rates among all cancer types. Across all patients with pancreatic cancer, relative 5-year survival is 9% and is less than 3% for those with advanced disease.2 The median survival for patients in end-stage of the disease is approximately 3 months. There are two main types of pancreatic cancer - adenocarcinomas, which accounts for approximately 93% of all pancreatic cancer, and neuroendocrine tumors. Pancreatic cancer is relatively uncommon with new cases accounting for only 2.5% of all newly diagnosed cancers. However, pancreatic cancer is the fourth most common cause of cancer death for men and women in the United States.
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 Tyme Technologies
Tyme Technologies, Inc., is an emerging biotechnology company developing cancer 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 cancer 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 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 “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; 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.
2Statistics adapted from the American Cancer Society's (ACS) publication, Cancer Facts & Figures 2019.
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