A clinical trial will assess whether Tyme Technologies’ SM-88 is a better treatment option than active surveillance for prostate cancer patients who have not had surgery, radiation, or chemotherapy.

Tyme has asked an expert in prostate cancer treatment, Mack Roach III of the University of California at San Francisco, to lead the study. SM-88 consists of three different cancer therapies.

Roach, a professor of radiation oncology, medical oncology and urology, has conducted some of the world’s largest trials in advanced prostate cancer that has not spread to other areas of the body.

Tyme and Roach may also do trials that involve patients whose cancer returned after standard therapy.

“We are very excited to have a leader in the field like Dr. Roach approach us with the idea for these trials,” Dr. Giuseppe Del Priore, Tyme’s chief medical officer, said in a press release. “By partnering with UCSF [the University of California at San Francisco], we hope to demonstrate proof-of-concept for SM-88 in this important treatment category without diverting core resources from our critical work in metastatic cancers.” Metastatic cancers are those that have spread to other areas.

SM-88 is designed to stop metabolic processes crucial to cancer cell survival. It combines the chemistry of three well-known therapies to shut down cancer cells’ defenses without affecting surrounding healthy tissue.

“A spectrum of patients,” running from those suitable for active surveillance “to those with high-risk and relapsing prostate cancer, face a number of difficult choices” about their disease, Roach said. “In some, it is whether to delay treatment” and go with active surveillance, “waiting for symptomatic progression, or be aggressive by initiating potentially toxic treatment as soon as possible,” he said.

Based on preliminary results showing biomarker improvements in early-stage prostate cancer patients and signs of improvement in late-stage patients, “SM-88 could have a potential role throughout the wide spectrum of this disease,” Roach said. SM-88 could also become an important alternative for the many patients who have never been treated, he said.

Tyme has been conducting an ongoing Phase 2 trial (NCT02796898) to evaluate SM-88’s safety and effectiveness in prostate cancer patients. Preliminary results showed that it delayed the disease’s progression and significantly reduced levels of tumor cells in blood.