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TYME’s SM-88 First Human Study in Patients with Metastatic Cancer Published in the Journal, Investigational New Drugs

  • New oral approach aimed at disrupting cancer metabolism
  • SM-88 is an investigational Cancer Metabolism-Based Therapy (CMBTsTM) that has demonstrated responses across 15 different cancers
  • 30 patients enrolled in study with actively progressing metastatic cancer and received only SM-88 therapy
  • 29.8 months median overall survival including 13 months of progression free survival (PFS) without additional therapy
  • 33% of patients (10/30) achieved RECIST complete response (CR) or partial response (PR)
  • 57% of patients (17/30) achieved RECIST stable disease (SD) with a median duration of 11 months

NEW YORK, April 08, 2019 (GLOBE NEWSWIRE) -- Tyme Technologies, Inc. (TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs™), announced that the results of its first human study, completed as of September 15, 2017 and designed to evaluate the safety, tolerability and efficacy of SM-88 in patients with advanced metastatic cancers, was published online on March 30th 2019 in the peer-reviewed journal Investigational New Drugs. The article, titled “A first-in-human study of the novel metabolism-based anti-cancer agent SM-88 in subjects with advanced metastatic cancer,” is available online at https://link.springer.com/article/10.1007/s10637-019-00758-8

TYME’s SM-88 was designed to leverage innate changes in cancer metabolism that are fundamental to support the cancer’s proliferation. The Warburg Effect is prevalent across most solid and hematological malignancies impacting energy production and the uptake of amino acids, including non-essential amino acids. SM-88 is a chemically modified form of the non-essential amino acid tyrosine, designed to be selectively consumed by the cancer cell, causing a disruption of protein synthesis that leads to a catastrophic failure and death of the cancer cell.  

Based on these proof-of-concept clinical findings, TYME is developing new approaches, including SM-88, that target cancer metabolism. As metabolic changes in tumor cells are nearly universal (the Warburg Effect has been reported in over 90% of tumors1), TYME believes that targeting these mechanisms creates the possibility of delivering potent therapeutic benefit across a broad spectrum of solid tumors and blood cancers.

The SM-88 first human study was a TYME-sponsored, open-label, single-center first in human study of 30 patients with metastatic cancers who had failed or refused all available therapeutic options. In this study, SM-88 was used with low doses of melanin, melanotan 2, phenytoin, and sirolimus (M2PS). Based on results from the study, clinical researchers observed that patients reached a median overall survival of 29.8 months and 13 months of progression free survival (PFS) without additional therapy. 33% of patients (10/30) achieved RECIST complete response (CR) and partial response (PR) with median time to best response of greater than 3 months. 57% of patients (17/30) achieved RECIST stable disease (SD) with a median duration of 11 months.

“The peer-reviewed publication of our first human study results in the journal Investigational New Drugs further validates the encouraging data of this oral treatment, SM-88, both in solid tumors and blood cancers,” said Giuseppe Del Priore, M.D., M.P.H., Chief Medical Officer at Tyme Technologies. “These results compelled TYME to advance its clinical studies in pancreatic, sarcoma and prostate cancers in the interest of patients who are looking for new treatment approaches in advanced cancers where there are few to no options.”

SM-88 used with M2PS demonstrated a favorable safety profile and was well tolerated. All related AEs for SM-88 with M2PS were classified as mild or moderate. The most common treatment related adverse events (AEs) experienced included hyperpigmentation by 100% of patients (30/30), fatigue by 56.7% of patients (17/30) and pain by 10% of patients (3/30). No dose limiting toxicities were observed.

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 the First Human Study
The SM-88 first human study was a single-center, open label, phase I trial evaluating 30 heavily pretreated patients with actively progressing metastatic cancers who had multiple prior systemic therapies and had significant expected disease related mortality. The first patient was enrolled in January 2012. After one cycle, patients who tolerated SM-88 were allowed to continue treatment for additional cycles, until disease progression or discontinuation for other reasons. Patients were followed until September 19, 2017, when a final data analysis was performed. 

The primary objective of this study was to evaluate the safety and tolerability of SM-88.  The secondary objectives of this study were to assess the PFS of patients treated with SM-88; assess measures of efficacy, including best overall response rate, duration of response, and overall survival; and to explore changes in health-related quality of life using patient-reported outcomes following treatment with SM-88.

The number of patients in this study was considered adequate to provide initial evidence of safety and to explore the clinical utility of SM-88. This study was not powered for efficacy endpoints.

About SM-88
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.

1. Hanahan D, Weinberg RA (2011) Hallmarks of cancer: the next generation. Cell 144 (5):646-

Contact

Ashley R. Robinson
LifeSci Advisors, LLC
617-535-7742
arr@lifesciadvisors.com 

Source: Tyme Technologies, Inc.