Phase 1 of the Phase 1/2A study established the maximum tolerable dose for TBC-1002 in patients with low grade non-muscle invasive bladder cancer. Phase 2 will further establish responder rates by administering the dose established in Part 1 in a marker lesion study in similar patients.

Phase 1 study results demonstrated escalating doses of TBC-1002 to be well tolerated with no dose limiting toxicity, and no irritative voiding (cystitis) symptoms. No systemic exposure or toxicity was observed, even with high concentrations of TBC-1002 being delivered topically to the bladder wall. Phase 1 results also indicated preliminary efficacy with no evidence of bladder tumor recurrences observed up to 15 months after dosing in all but one patient. Adverse events were minor and not considered study related.

In August, LIPAC commenced a Phase 2A marker lesion clinical study to establish efficacy responder rates within 16 weeks. Efficacy data will begin to read-out in November and will predict long-term (two-year) recurrence free survival rates. The full study results will be available in the first quarter of 2020.

TBC-1002 is a proliposomal intravesical paclitaxel formulation (PLIP), in development for intravesical administration in the treatment of non-muscle invasive bladder cancer (NMIBC). NMIBC is a common and highly recurrent disease that can often be difficult to treat. TBC-1002 would be the first chemotherapeutic agent to be approved by the U.S. Food and Drug Administration for this indication in almost two decades.

Read more about the Ongoing Trial