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TYME Presents Positive Circulating Tumor Cell Data from TYME-88-Panc Study in Patients with Advanced Pancreatic Cancer at AACR PANC 2019

  • TYME-88-PANC Phase II study showed patients being treated with SM-88, who achieved at least an 80% reduction in circulating tumor cell burden, demonstrated a 60% decrease in risk of death
  • SM-88 is an oral, investigational cancer metabolism-based therapy that has demonstrated responses across 15 different cancers
  • SM-88 is a new approach aimed at disrupting cancer metabolism in metastatic pancreatic cancer; ~ 50,000 cases annually in U.S. alone
  • Targeted mechanism of action resulted in less than 2% of patients experiencing serious adverse events related to SM-88 in clinical trials
  • Plans to initiate pivotal trial in third-line pancreatic cancer in Q3’2019

NEW YORK, Sept. 09, 2019 (GLOBE NEWSWIRE) -- Tyme Technologies, Inc. (TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs™), reported encouraging data on circulating tumor cells (CTCs) and a correlation with decrease in risk of death using TYME's lead candidate, oral SM-88 (racemetyrosine), in patients with metastatic pancreatic cancer. The data were presented at the AACR Special Conference on Pancreatic Cancer: Advances in Science and Clinical Care, taking place September 6-9, 2019, at the Westin Copley Place in Boston, Massachusetts.

CTCs have long been known to exist in cancer patients' blood, with a clear correlation established between the number of CTCs and disease progression as previously reported by other authors in a number of cancer types including pancreas, prostate, and breast cancer.  CTC data from the TYME-88-PANC Phase II study using oral SM-88 in poor prognosis pancreatic cancer (PDAC) patients illustrate that there are efficacy correlates with overall survival (OS) beyond traditional RECIST responses. The clinical significance of CTCs has shown that the concentration of CTCs in patient’s blood correlates with poor prognosis, at baseline and throughout treatment, and may be a clinically relevant biomarker for patients with metastatic pancreatic cancer.

"These data reporting the use of SM-88 in PDAC illustrate that there are clear efficacy correlates with overall survival beyond traditional RECIST responses, including CTC measures. This is the second TYME study that has shown a CTC effect,” said Giuseppe Del Priore, M.D., M.P.H., Chief Medical Officer at TYME. “The association between decreases in CTCs and overall survival had not been previously as well-documented prospectively in PDAC as compared to other tumor types. CTC reduction may be considered a potential tumor marker for patients treated for pancreatic cancer.  While still preliminary, we believe these data represent another important step forward in advancing cancer metabolism-based therapies for patients with metastatic pancreatic cancer.” 

The ongoing multicenter open-label Phase II TYME-88-Panc study involved 49 heavily pretreated patients with radiographically progressive metastatic pancreatic cancer who had significant disease-related morbidity before receiving TYME’s investigational agent SM-88. More than 80% of patients had received at least two prior lines of therapy. Of the 49 patients, 38 patients were evaluable for efficacy, as defined in the protocol. In this study, based on information available as of April 25, 2019, the median overall survival of evaluable patients (N=38) was 6.4 months. Certain efficacy indicators correlated with greater OS, including decreases in CTCs.

The measurement of CTCs continues to emerge as an important prognostic indicator in patients with pancreatic cancer. This is now the second TYME study in cancer patients showing that SM-88 reduces CTCs. In a previous study of patients with prostate cancer, SM-88 treatment was also associated with a reduction in CTC count1. In the TYME-88-Panc study, the results of the evaluation of CTCs were very encouraging. TYME plans to study CTCs as a potential prognostic indicator in the TYME pivotal pancreatic study.

In the TYME-88-Panc study, the baseline of median CTCs in all evaluable patients was 144.6 CTCs/4mL. Patients with both absolute and relative decrease from baseline CTCs demonstrated greater OS. A median reduction of 63% in CTC burden was observed in evaluable patients. Those patients (10 of 24) with available results reaching an 80% reduction or greater in CTCs demonstrated a 60% decrease in risk of death (hazard ratio=0.40).

A RECIST clinical benefit rate (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 the majority of these patients remaining in stable disease or better at more than 7 months after receiving treatment with SM-88.

The TYME-88-Panc research results are from an investigational study. SM-88 is not approved for the treatment of patients with any disease condition. 

Details of this study were presented at the AACR Special Conference on Pancreatic Cancer: Advances in Science and Clinical Care, taking place September 6-9, 2019, at the Westin Copley Place in Boston, Massachusetts. The poster is available on our website (www.tymeinc.com/data-publications).

The SM-88 poster presented at AACR Special Conference on Pancreatic Cancer is as follows:  

Title:   CTC-based Efficacy of SM-88 Correlates with Overall Survival in Advanced Pancreatic Cancer
Authors:   Marcus Smith Noel1, Andrea Wang-Gillam2, Allyson J. Ocean3, Sant  Chawla4, Vincent Chung5, Ron Korn6, Giuseppe Del Priore7, Vincent J. Picozzi8
Institutions:  1University of Rochester Wilmot Cancer Institute, Rochester, NY, 2Washington University, St. Louis, MO, 3Weill Cornell Medical College, NY, 4Sarcoma Oncology Center, 5Santa Monica, CA, 5City of Hope, 6Imaging Endpoints, Scottsdale, AZ, 7Tyme Technologies, Inc., NY, NY, 8Virginia Mason Medical Center, Seattle, WA.
Session Title:  Poster Session B
Session Date and Time:  Saturday, September 7th from 12:45 p.m.–3:30 p.m.
Session Location:  Staffordshire Ballroom
Abstract Number: 54116822
Poster Number: B16


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 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 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 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 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.

1JCO 37, 2019 supp 7S; 83
2Statistics adapted from the American Cancer Society's (ACS) publication, Cancer Facts & Figures 2018.

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