Tyme Technologies has completed enrolling particpants in the Phase 1b portion of the open-label Phase 1b/2 clinical trial evaluating its lead investigational drug candidate SM-88 in non-metastatic prostate cancer patients with rising prostate-specific antigen (PSA) levels.
The open-label, multi-center, dose-escalating, dose-expansion clinical trial (NCT02796898) is evaluating the effectiveness, safety, and drug properties of SM-88 in reducing PSA in up to 42 patients with prostate cancer. The goal of the Phase 1b portion of the trial is to determine the recommended dose of SM-88 by evaluating the dose limiting toxicity (DLT) as well as the maximum tolerated dose (MTD) or minimum effective optimum dose.
The recommended dose of SM-88 established in this part of the study will be evaluated in the Phase 2 portion of the trial, which will be administered to 30 patients for six cycles or until unacceptable toxicity, disease progression, or any of the treatment discontinuation criteria are met.
The effectiveness of SM-88 will be measured through PSA levels, circulating tumor cells and other outcomes, according to the Prostate Cancer Working Group 3 (PCWG3) guidelines.
After this study is complete, Tyme will report results on PSA levels and novel biomarker components, as well as patients’ progression-free survival.
“We are pleased with how quickly this study has moved forward,” Dr. Giuseppe Del Priore, Tyme’s chief medical officer, said in a press release. “We hope that our metabolic approach that targets only active cancer cells will have fewer and less severe side effects than current standards of care and will improve outcomes.”
SM-88 is an investigational drug designed to only penetrate living cancer cells and introduce multiple mechanisms to kill the cells without any toxicity or involvement of healthy tissue.
Tyme believes SM-88 may lead to cancer cell death by inducing transfer of electrons in the cancer cells that allow the formation of free radicals that react and stress the cell.
According to the company, SM-88 could create an engineered metabolic response to use oxidative stress to kill cancer cells. SM-88 combines a novel molecule developed by Tyme with three currently-marketed cancer treatment drugs which are considered safe for their already approved indications.