Interim Phase II Safety and Efficacy Data for SM-88 in Prostate Cancer Announced at 2018 ASCO Genitourinary Cancers Symposium

Truckee, CA ( Tyme Technologies, Inc. (NASDAQ: TYME), a clinical-stage biotechnology company developing cancer therapeutics, announced efficacy and safety data from an ongoing Phase II trial of SM-88 in patients with non-metastatic, biochemical-recurrent prostate cancer (nmPC). Mack Roach III, M.D., FASTRO, FACR, University of California, San Francisco (UCSF), presented the data in a poster session at the 2018 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium in San Francisco, Calif. 

  • 92% of Patients Have Maintained Radiographic Progression-Free Survival at a Median of 12 Months Since Biochemical-Recurrence
  • All Patients Have Reported Stable Cognitive and Sexual Function on SM-88 Treatment
  • No Reported Drug-Related Serious Adverse Events on SM-88 Treatment to Date
  • Data Presented by Professor Mack Roach III, M.D., UCSF
“Prostate cancer patients have limited treatment options and are likely to receive ADT (androgen deprivation therapy), a hormone therapy that lacks sufficient evidence of efficacy in non-metastatic prostate cancer and may produce considerable toxicities and a reduction in quality of life,” said Dr. Roach, Professor of Radiation Oncology, and Urology at UCSF. “Toxicities typically associated with ADT have not been seen with SM-88, which suggest that ADT may be avoided or delayed without progression in patients with non-metastatic prostate cancer. I look forward to continuing to work with Tyme to explore the benefits of SM-88 as an alternative to hormone therapy in prostate cancer patients, particularly those pursuing active surveillance.”
Thirteen evaluable patients were assessed from an ongoing Phase II trial of SM-88 in nmPC with rising prostate-specific antigen levels, detectable circulating tumor cells and no radiographically detectable metastases. Most patients had previously received ADT after radiation therapy or surgery, but ADT treatment was not permitted during the trial. 

Currently, 92 percent of patients (12/13) have maintained radiographic progression-free survival (rPFS) with a median of 12 months since documented biochemical recurrence, and 10 months since starting SM-88 treatment. All 12 patients who have maintained rPFS also exhibited meaningful reductions in circulating tumor cells (CTCs), while the one patient experiencing radiographic progression had a rise in CTCs. 

“CTCs are emerging as an important biomarker in predicting outcomes in prostate and other cancers,” said Giuseppe Del Priore, M.D., Chief Medical Officer of Tyme. “We are encouraged by the broad impact SM-88 appears to have on CTCs and will continue to assess these effects in this and future trials of SM-88.”

Eighty-five percent (11/13) of patients demonstrated rising or stable testosterone levels, with no drugrelated serious adverse events (grades 3 or 4) observed. According to the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire, all patients reported stable cognitive and sexual function domain measures, including 100 percent (13/13) reporting improved or stable “interest in sex,” 62 percent (8/13) reporting no or resolved hot flashes, and 54 percent (7/13) reporting to have “excellent” “overall health” and “quality of life.” Patient weight, EKG QTc, osteoporosis (measured by urine NTx), glucose and hematocrit did not appear affected while receiving SM-88. 

“We are excited by the promising safety, tolerability and efficacy data seen in non-metastatic prostate cancer patients treated with SM-88 therapy,” said Dr. Del Priore. “We look forward to reporting full Phase II data in the second half of 2018 and advancing our prostate cancer collaboration with Dr. Roach in various settings of active surveillance.”

About SM-88 SM-88: 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 shown 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) and Tyme is finalizing the preparations for the Phase II clinical trial in metastatic pancreatic cancer.

Read More:
Complete Coverage: 2018 ASCO GU Conference