Tyme Technologies, Inc. announced that it has begun enrolling research subjects in the second stage of its Phase Ib/II open-label trial using monotherapy SM-88 treatment for progressive prostate cancer. This follows encouraging preliminary data from the first stage of this trial in safety and circulating tumor cells (CTCs) at both dosage levels. Three subjects in the trial have been enrolled for a sufficient period for evaluable data and have shown consistent preliminary data trends. CTCs in the first subject dropped below detectable levels and have remained undetectable for the subsequent two monthly cycles. CTCs for the next two subjects fell by the start of the second and third cycles, respectively. In all three subjects, no drug-related Grade 2 or higher toxicities were observed and subjects self-reported some improvement in quality-of-life measurements. A fourth subject is also enrolled, but not for sufficient time to have evaluable data. As there were no observed differences in safety or tolerability between the lower-dose version of SM-88, given to the first subject, and the higher dose version, given to the other subjects, the higher-dose version will be used for the second stage of the trial. Currently enrolling at multiple sites for Phase II participation, including investigators affiliated with Mount Sinai Beth Israel, AECOM, NYU School of Medicine, and Winthrop-University Hospital. Circulating tumor cells at non-detectable or declining levels in first evaluable research subjects. Positive preliminary pharmacokinetic and safety analysis. No serious adverse events related to SM-88 administration in any clinical trial testing to date.