TYME Receives FDA Guidance on Pivotal Trial for SM-88 in Treatment for Advanced Pancreatic Cancer

Tyme Technologies (NASDAQ:TYME) has announced it has received design guidance for a registrational trial from the US Food and Drug Administration (FDA) for a drug development pathway for SM-88 in third-line pancreatic cancer.

As quoted in the press release:

 The planned trial is intended to be a pivotal trial in the third-line setting to support a submission for FDA approval upon achievement of the trial endpoints and satisfaction of customary regulatory requirements.

SM-88 is an investigational oral metabolic-based cancer therapy being studied for the treatment of patients with advanced pancreatic cancer. Based on the FDA’s feedback, as well as ongoing discussions with the TYME Pancreatic Medical Advisory Board, TYME is in the process of finalizing a randomized pivotal trial protocol with a primary endpoint of overall survival.

“We thank the FDA for its guidance, which provides instruction for our regulatory path forward in a patient population that has no standard of care and an expected prognosis of only a few months survival,” said Steven Hoffman, Chairman and CEO at Tyme Technologies, Inc. “By leveraging our existing trial infrastructure from our TYME-88-Panc study, and the momentum generated from the first stage of that trial, we aim to advance a treatment that could offer both patients and physicians a needed option for third-line advanced pancreatic cancer as quickly as possible.”

The TYME-88-Panc results are from an investigational study. SM-88 is not approved for the treatment of patients with advanced pancreatic cancer.

Click here to read the full press release.