• 40 percent of evaluable patients achieved survival of more than 12 months, 30 percent achieved a complete or partial tumor response
  • All patients improved or maintained quality of life measures and pain scores

SAN FRANCISCO, CA, USA I January 19, 2018 I Tyme (Nasdaq:TYME), a clinical-stage biotechnology company developing cancer therapeutics, today announced efficacy and safety data for SM-88 in patients with advanced metastatic or recurrent pancreatic cancer. The data were presented today in a poster presentation at the 2018 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium in San Francisco, Calif.

“We are encouraged by the early efficacy signals demonstrated by SM-88 without report of drug-related serious adverse events in pancreatic cancer, a devastating disease that lacks safe and effective treatment options,” said Giuseppe Del Priore, M.D., Chief Medical Officer of Tyme. “We look forward to exploring SM-88 in a larger prospective Phase II trial this year in pancreatic cancer patients who have failed prior therapy.” 

Data from 10 pancreatic cancer patients treated with SM-88 in Tyme’s First Human Study or compassionate use program were evaluated for overall survival, overall response rate, progression-free survival, Eastern Cooperative Oncology Group (ECOG) performance status and pain scores.   

Many evaluable patients demonstrated prolonged survival with 40 percent (4/10) surviving more than 12 months, and 30 percent (3/10) achieving a complete or partial response. All subjects (10/10) reduced or maintained pain scores during their first cycle of SM-88 therapy, in addition to gaining or maintaining weight. Eighty percent (8/10) of patients showed improvement in ECOG performance status during the first treatment cycle, with 30 percent (3/10) demonstrating an improvement of greater than one point during this six week period. All patients improved or maintained European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire subject-reported health and quality of life outcomes after initiating SM-88 therapy.

About SM-88

SM-88 is a novel combination therapy that utilizes a proprietary dysfunctional tyrosine derivative to interrupt the metabolic processes of cancer cells, breaking down the cells’ key defenses and making them vulnerable to oxidative stress and death. SM-88 has demonstrated efficacy in the treatment of multiple oncology indications, including breast and prostate cancer, without reports of significant toxicity or serious adverse events.

SM-88 is being evaluated in a Phase II clinical trial for prostate cancer (NCT02796898). A Phase II clinical trial in pancreatic cancer is planned to initiate in 2018.

About Tyme

Tyme Inc. is a clinical-stage biotechnology company developing cancer 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. Tyme’s lead clinical program, SM-88, is a first-in-class combination therapy in Phase II development for prostate cancer. The Company is preparing to initiate an additional Phase II clinical trial in pancreatic cancer in 2018.

For more information, visit www.tymeinc.com.

SOURCE: Tyme