Tyme Inc. - TYME Trials

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Changing the Course of Cancer Care

By 2026, approximately 20 million people in the U.S. will be living with cancer. As the needs of surviving cancer patients evolve worldwide, TYME remains dedicated to advancing its pipeline of proprietary Cancer Metabolism-Based Therapies (CMBTs™) for difficult-to-treat cancers. Our focus is to advance our research to reach patients in need around the world who experience advanced metastatic cancers and life-threatening rare diseases.

CMBTs are investigational proprietary compounds that are hypothesized to disrupt the protein synthesis 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 our lead oral candidate, SM-88, has demonstrated encouraging tumor responses across 15 different cancers, including pancreatic, lung, breast, prostate, sarcoma and lymphoma cancers with minimal Grade 3 or higher serious adverse events.

Clinical trials are essential to our research and development work, through which we want to ensure that our medicines are better and safer. We strive to give cancer patients with limited treatment options hope for a longer, better life.

Why Participate?

Patients enroll in clinical trials for many reasons. These often include interest in advancing science and medical care, interest in gaining access to new, experimental treatments – especially if all other treatment options have failed – and also, interest in learning more about their medical condition. Some patients may benefit from participating in a clinical trial if the investigational drug turns out to be effective, but there is no guarantee that a volunteer will receive any direct benefit.

By volunteering to participate in clinical trials, participants help advance what we know about medical interventions. In doing so, clinical trial participants can play an important role in getting new drugs and devices approved for use in treating other patients.

Questions About a Trial?

FAQ

Find Active Trials

TYME Sponsored Pancreatic Cancer Trial: A prospective, open-label Phase II/III trial in metastatic pancreatic cancer subjects who have failed two lines of any prior systemic therapy. The two part trial is designed to evaluate the safety and efficacy of SM-88 used with MPS (methoxsalen, phenytoin and sirolimus) in pancreatic cancer and will measure multiple endpoints, including overall survival, progression free survival, relevant biomarkers, quality of life, safety, and overall response rate. (Part 1: Enrollment Complete)

TYME Pancreatic Trial: Part 2 Actively Recruiting

TYME/JAF HopES Sarcoma Trial: The HopES Phase II trial evaluating the potential benefits of SM-88 for patients with high-risk sarcomas. This prospective, open-label, pilot Phase II trial evaluates the efficacy and safety of SM-88 in two cohorts of patients: 1) as maintenance therapy following standard primary or palliative treatments for Ewing's sarcoma patients with high risk of relapse or disease progression; and 2) as salvage therapy for patients with clinically advanced sarcomas.

Find a Sarcoma Trial

TYME/PanCAN Precision Promise℠ Trial: TYME SM-88 as an experimental arm in the novel Precision Promise adaptive Phase II/III trial platform sponsored by the Pancreatic Cancer Action Network (PanCAN). The primary goal is to initially study SM-88 as a monotherapy treatment arm for patients who have failed one prior line of chemotherapy. Additionally, it is planned that SM-88 will be evaluated in combination with gemcitabine (Gemzar^®) and nab-paclitaxel (Abraxane^®) for both first- and second-line subjects.

PanCAN Precision Promise^SM

Previous Trials

TYME Sponsored Prostate Cancer Trial: The purpose of this study ∂is to evaluate the safety, pharmacokinetics, and efficacy of SM-88 in patients with prostate cancer that has not become metastatic. This is an open-label, multi-center, dose-escalating, dose-expansion study of SM-88 in patients with prostate cancer. This study includes 2 phases, a dose-escalation phase that includes PK evaluation, and a dose-expansion phase.

TYME Prostate Trial is Completed

Compassionate Use

TYME is focused on advancing the development of SM-88 used with MPS. However, at this moment SM-88 remains an investigational therapy and it is not approved for any indication in any disease.

We appreciate the importance that a product like SM-88 might represent to individuals with cancer.

At this time, we are unable to provide access to our investigational treatment through a “compassionate use” or “pre-approval access” program. If you are interested in participating in a clinical trial of SM-88 used with MPS, we encourage you and your oncologist to visit clinicaltrials.gov.

We are committed to working diligently within the FDA drug development system to gather the safety and efficacy data necessary for marketing approval so that it may reach the greatest number of patients as quickly as possible. Our goal is to conduct this clinical program rapidly, but without sacrificing the scientific and clinical rigor that the FDA requires.

We will continue to reassess our compassionate use policy as circumstances dictate. Please continue to check our website for additional information.

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PanCAN (Pancreatic Cancer Action Network) is a great resource for information regarding pancreatic cancer. You can visit their website at pancan.org. Patient Central at PanCAN is dedicated to offering support and guidance for patients and caregivers in all areas of pancreatic cancer.