Preliminary results from a Phase 1b/2 clinical trial evaluating the safety, pharmacokinetics, and efficacy of TYME-88 (SM-88) to treat recurrent, non-metastatic prostate cancer found that all eight enrolled patients, who did not yet have lesions detectable on X-rays, did not go on to develop any.
The presentations, “SM88 in non-metastatic rising PSA-recurrent prostate cancer,” and “SM88/SMK non-hormonal therapy in recurrent or untreated prostate cancer,” were given at the recent 2017 Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago.
TYME-88, being developed by Tyme Technologies, is designed to penetrate living cancer cells and uses several mechanisms to kill them, possibly by inducing transfer of electrons in the cancer cells to allow free radicals to react and stress the cells. In the presentations, it is defined as a combination of substituted amino acid and repurposed agents with non-toxic activity.
The ongoing six-month, open-label, multi-center study (NCT02796898) includes patients with recurrent prostate cancer, identified as a rise in PSA levels, before detectable lesions can be found.
Results presented at the conference were from eight patients and showed that detectable lesions were prevented in all participants. There was a reduction in the tumor cells circulating in the blood in 87.5 percent of participants. Use of toxic therapies, including ADT and chemotherapies, were delayed in all patients and no one reported a worsening of symptoms.
No severe adverse events and few mild to moderate adverse events (Grades 1 and 2) have been identified to date in study participants.
“There was no significant toxicity or adverse patient reported outcomes. Based on these results, the dose escalation was stopped at the second level and a cohort expansion phase II initiated. A phase III [randomized clinical trial] is planned for confirmation of these results,” the authors stated.
“Although these are preliminary results in a small sample size, the consistency of response across subjects and outcomes, suggest that TYME-88 may be a viable alternative for maintenance therapy in recurrent, non-metastatic prostate cancer,” Dr. Giuseppe Del Priore, chief medical officer at Tyme, said in a press release. “Given the important quality of life issues that patients with prostate cancer face, it is our hope that TYME-88 will become a relatively non-toxic treatment option for patients and medical professionals looking to delay or avoid more toxic treatments.”
Tyme technologies is advancing its study into Phase 2, with plans to enroll 42 prostate cancer patients — all with documented prostate-specific antigen (PSA) progression — at four sites in New York. More information is available on the study’s clinical trials.gov webpage.