TYME Announces First Patient Dosed in TYME-88-Panc Pivotal Trial to Evaluate SM-88 as Oral Treatment for Patients with Metastatic Pancreatic Cancer


NEW YORK, Jan. 08, 2020 (GLOBE NEWSWIRE) -- Tyme Technologies, Inc. (NASDAQ: TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs™), today announced that the first pancreatic cancer patient has been dosed in Part 2 of the TYME-88-Panc pivotal trial designed to support approval of SM-88 (racemetyrosine) for the third-line treatment of patients with metastatic pancreatic cancer. 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.

"Patients with metastatic pancreatic cancer have a very poor prognosis. For those 10,000 patients actively seeking third-line treatment, there are currently no FDA-approved therapies and no oncology guideline recommendations for active therapy. We are passionate about advancing new treatment options for these patients," said Giuseppe Del Priore, M.D., Chief Medical Officer at TYME. "In clinical trials, SM-88 has demonstrated clinical responses across 15 different tumor types in clinical trials involving approximately 180 patients. 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 pivotal study."

Based on encouraging results demonstrated in Part 1 of the TYME-88-Panc study of SM-88, TYME has launched Part 2 of 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 or 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.

Recent results, based on data as of April 25, 2019, from Part 1 of the TYME-88-Panc study, were presented at the European Society of Medical Oncology 21st World Congress on Gastrointestinal Cancer in Barcelona, Spain on Wednesday, July 4, 2019 (link to TYME poster). The study demonstrated a median overall survival in evaluable patients (38 of 49) of 6.4 months. These survival results compare very favorably to the analysis of 19 prospective pancreatic cancer trials where the median reported survival after progressing on second-line therapy was 2.0 – 2.5 months1 based on reported historical trials. In Part 1 of the TYME-88-Panc study, a RECIST CBR of stable disease or better was achieved by 44% of patients (11 of 25) with available imaging. Patients achieving stable disease or better demonstrated a statistically significant (p=0.02) improvement in survival with a 92% reduction in risk of death (hazard ratio=0.08). The CBR was durable with majority of patients remaining in stable disease or better for more than 7 months after receiving treatment with SM-88. The study showed a median reduction of 63% in CTC burden in evaluable patients. Of the 24 patients with available results, those reaching an 80% reduction or greater in CTCs (10 of 24) demonstrated a 60% decrease in risk of death (hazard ratio=0.40).

The Phase II portion of the TYME-88 Panc study reported that SM-88 was well tolerated with only 4.0% of patients (2 of 49) experiencing serious adverse events (SAEs) deemed at least possibly related to SM-88 (abdominal pain, arthralgia, and hypotension). One patient with reported SAEs continued on treatment.

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 8% 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 90% of all pancreatic cancer, and neuroendocrine tumors. Pancreatic cancer is relatively uncommon with new cases accounting for only 2.1% 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.  

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 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 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 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.  

1Manax et al 2019 J Clin Oncol 37, 2019 (suppl 4; abstr 226)
2Statistics adapted from the American Cancer Society's (ACS) publication, Cancer Facts & Figures 2018.

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