Clinical Trials

Home / Clinical Trials


Our clinical and research trials create medically important data that tests how well SM-88 works in patients. Our studies are designed to answer scientific questions and the needs of the patients. Tyme Inc. is constantly seeking better ways to treat all types of cancers. Our studies are designed to test our drug as a monotherapy and in combination platforms. Tyme runs trials in parallel with traditional lines of treatment to create comparative analysis. When trials are complete, our goal is to provide our results to all the appropriate regulatory agencies, healthcare providers, people with cancer and the public. Every clinical trial has a well-defined protocol, and/or action plan. The protocol describes an overview of the study, the science behind mechanism of action, how the study will be conducted, and why a particular indication was chosen. Each study has an inclusion and exclusion criteria which defines who can participate. Some cancer indications studies do require recruiting volunteers. All protocol designed studies are approved by Institutional Review Board (IRB- is an independent committee of physicians, statisticians, and members of the community), monitors, and the FDA.

Our primary goal is to:

  • Define the efficacy of SM-88
  • Protect the rights and welfare of the participants
  • Define the risks and make sure they are reasonable when compared to conventional treatments

(In the United States, a clinical trial must have an IRB if it is studying a drug, biological product, or medical device that the Food and Drug Administration (FDA) regulates, or it is funded or carried out by the federal government).


Study of the Optimum Dose, Efficacy, Safety, and Pharmacokinetics of SM88 in Patients With Prostate Cancer


Prostate Cancer;   Androgen Independent Prostate Cancer;  Rising PSA;  Castrate Resistant Non-Metastatic Prostate Cancer (CRNMPC)


Drug: SM-88 (Cohort 1);  
Drug: SM-88 (Cohort 2);
Drug: SM-88 (Cohort 3);  
Drug: SM-88 (Cohort 4)