Favorable Interim Data Presented for Tyme’s SM-88 Phase 2 Trial for Prostate Cancer Patients

Favorable Interim Data Presented for Tyme’s SM-88 Phase 2 Trial for Prostate Cancer Patients
Tyme Technologies' SM-88 reduced the levels of circulating cancer cells — an indicator of metastatic disease — in all prostate cancer patients treated in an ongoing Phase 2 trial, according to data revealed at the European Society for Medical Oncology (ESMO) 2017 Congress, in Madrid, Spain. The findings support the potential of SM-88 as a relatively non-toxic alternative to current standard of care — chemotherapy or androgen deprivation therapy (ADT) — in this subset of non-metastatic patients who had rising PSA levels, but no visible tumor. The poster presentation was titled “Phase II Trial of SM-88 in Non-Metastatic Biochemical Recurrent Prostate Cancer” and presented by Giuseppe Del Priore, MD, chief medical officer at Tyme. "Current standards of care for prostate cancer are associated with high toxicity and/or serious quality of life issues," Del Priore said in a press release. "In fact, many urologists are starting to question the clinical benefits of ADT, which is associated with significant physiological and emotional side effects." SM-88, also known as TYME-88, is an investigational drug designed to target live cancer cells. It combines the chemistry of several well-known therapies to trigger multiple mechanisms that will kill cancer cells without affecting or involving surrounding healthy tissues. The open-label, multi-center Phase 2 trial (NCT02796898) is enrolling up to 34 patients with biomarker-recurrent, non-metastatic prostate cancer who have increasing PSA levels and no detectable lesions. The patients will receive 230 mg of SM-88 daily, administrated orally, for up to six months. The trial is expected to conclude in the first half of 2018. Preliminary data from the first nine patients who received SM-88 therapy for at leas
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