TYME TRIALS

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.

 

What is Pancreatic Cancer?

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Find Active Trials

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. 



Compassionate Use

TYME is focused on advancing the development of SM-88 used with MPS, a therapy designed to be broadly effective across a range of tumor types.

Based on the clinical evidence from studies to date, we understand the potential that a product like SM-88 would have in oncology. We appreciate that a product like SM-88 would give hope to an individual with cancer to seek treatment while maintaining quality of life.

While we recognize the immediate need, we must also work appropriately within the drug development system. Our product candidate is currently in clinical development and we are working with the Food and Drug Administration (FDA) to develop a clinical program that will provide TYME with the necessary safety and efficacy data to seek marketing approval of SM-88, so that it may reach the greatest number of patients. Our goal is to conduct this clinical program rapidly, but without sacrificing the scientific rigor that the FDA requires.

At this time, we are not providing access to our investigational treatment through “compassionate use” or “pre-approval access” programs. However, we will continue to reassess our policy. Please continue to check our website for information.

If you are interested in participating in a clinical trial of SM-88 used with MPS, we encourage you and your oncologist to visit our website or clinicaltrials.gov, where we will make a list of our studies available.