Indications

Topotarget'development of belinostat is planned in collaboration with the National Cancer Institute (NCI) in the US.

Topotarget is currently conducting a registration trial in PTCL. Registration opportunities also exist in other hematological malignancies including acute myeloid leukemia (AML) and multiple myeloma. Preliminary discussions with relevant regulatory authorities have been conducted for a number of indications.

Topotarget is currently evaluating multiple opportunities for other registration programs including possibilities based on the compelling data in ovarian cancer in combination treatment (BelCaP, carboplatin/paclitaxel). This treatment combination represents standard of care for a number of significant cancer indications, including non-small cell lung cancer (NSCLC), cancer of unknown primary site (CUP), and ovarian cancer. These indications represent registration opportunities for belinostat in a BelCaP combination. A direct step in taking advantage of the BelCaP option is to obtain proof-of-concept in a randomized clinical trial. Topotarget has initiated a randomized Phase II trial in CUP. Positive data in this trial would be the basis for initiation of pivotal trial in CUP.
Evolving data from studies both with intravenously and orally administered belinostat suggest registration opportunities in other large solid tumor indications, e.g. colorectal, pancreatic, and liver cancer.