TPI-287 study includes patients with disease metastatic to the brain as the drug, avoids the multidrug resistant (MDR) efflux pump and has demonstrated in pre-clinical studies its ability to cross the blood brain barrier.
Primary objective of the TPI-287 study is to assess the safety, tolerability and maximum tolerated dose (MTD) of TPI-287 in combination with temozolomide (TMZ) in adult patients with metastatic melanoma.
Archer Biosciences has conducted the trial on TPI-287 which involved treating, the successive cohorts of three patients per cohort with refractory or recurrent metastatic melanoma, with escalating doses of both TPI-287 (given intravenously weekly for three weeks of every four week cycle) and Temozolamide (given daily for the first five days of the four week cycle).
It is known that TPI-287 is active in animal models of human melanoma. Reportedly, in this study, animals receiving TPI-287 in combination with TMZ demonstrated an improvement in the overall survival compared to animals receiving no drugs or either of these drugs alone.