AADi is currently investigating the intravesical (administered into the bladder) use of ABI-009 in early stage or Non-Muscle Invasive Bladder Cancer (NMIBC) in a multi-center phase 1/2 study funded by a NIH fast-track STTR grant (R42CA171552) from the National Cancer Institute.
The phase 1 study has been completed and a combination phase 2 study (ABI-009 + gemcitabine, a standard of care) is ongoing (NCT02009332).
70,000 new cases of bladder cancer each year in the US, ~15,000 deaths
70-80% present with non-muscle invasive bladder cancer (NMIBC)
50% relapse after BCG treatment
Large prevalence pool (150k pts)
Limited treatment options for intravesical treatment
Trial initiated, NIH Funded