Following extensive testing in the laboratory and in animal
models with human tumors, the first-in-man clinical study was
successfully completed in 2006.
Belinostat has since been investigated in 30 clinical studies as
monotherapy and in combination chemotherapy and more than 1050
patients have been exposed to the drug.
Overall, patients have experienced clinical benefit from both
belinostat monotherapy and in combination with other anti-cancer
agents, as defined by objective responses or prolonged
stabilization of disease.
Clinical benefit has been observed in patients with solid tumors
and hematological malignancies.
The favorable safety profile for both intravenously and orally
administered belinostat and the encouraging anti-tumor activity
indicates a favorable risk/benefit ratio and justifies the
continued development of belinostat in multiple solid tumor and
hematological malignancy indications.
The clinical study program of on-going or recently completed
- Peripheral T-cell lymphoma (PTCL)
- Myelodysplastic syndrome (MDS)
- Acute myeloid leukemia (AML)
Solid tumor indications
- Cancer of unknown primary (CUP)
- Bladder cancer
- Ovarian cancer
- Liver cancer (HCC)
- Soft tissue sarcoma (STS)
- Non-small cell lung cancer (NSCLC)
- Colorectal cancer (CRC)