Great results on Pl-88 are moving this ahead this was the...

Great results on Pl-88 are moving this ahead this was the results of stage ii and soon we will get results from stage iii then we could see $10.00 plus big potential.


Three groups were included: one untreated arm (Group A) and two PI-88 arms (Group B: 160mg/day; Group C: 250mg/day). Treatment groups received PI-88 over nine 4-week treatment cycles, followed by a 12-week treatment-free period. Safety and optimal dosage were assessed.

Results

Overall, 172 patients were randomized and 168 were included in the intention-to-treat (ITT) population. Treatment-related adverse effects included cytopenia, injection site hemorrhage, PT prolongation, etc. Four serious adverse events were possibly related to PI-88 treatment. One (1.8%) group B patients and six (10.5%) group C had hepatotoxicity-related withdrawals. Among the ITT population, 29 patients (50%) in Group A, 35 (63%) in Group B, and 22 (41%) in Group C remained recurrence-free at completion. Calculated T1 value suggested 160mg/day treatment satisfied the criteria for the next stage of the trial.

Conclusions

PI-88 at 160mg/day is optimal and safe, and shows preliminary efficacy as an adjunct therapy for post-operative HCC.