Clinical use

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 studies includes:

Hematological diseases

• 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)
• Thymoma
• Non-small cell lung cancer (NSCLC)
• Colorectal cancer (CRC)