Ongoing Prostate Study
The six-month multi-center, open-label study is expected to enroll approximately 34 subjects with biomarker-recurrent prostate cancer who have rising prostate-specific antigen (PSA) levels and no radiographically detectable lesions. Subjects receive daily oral monotherapy with Tyme’s investigational drug therapy, SM-88.
Endpoints of our Phase II prostate study include:
- Prevention of radiographically-detectable lesions (i.e. maintained rPFS)
- Reduction in circulating tumor cells
- Safety and patient-reported outcomes
- PSA-doubling time (PCWG3 definition)
- Relevant biomarkers
In September 2017, Tyme presented interim data from an ongoing Phase II clinical trial in subjects with biomarker-recurrent non-metastatic prostate cancer at the European Society for Medical Oncology 2017 Congress (ESMO) in Madrid.
- Results suggest SM-88 may help avoid or delay more intensive treatments, such as chemical castration, in prostate cancer patients
- All subjects receiving study drug had radiographic progression-free survival throughout treatment
The Phase II trial is expected to be complete in the first half of 2018.