Ziopharm’s antimitotic drug found effective in cancer study

A total of 14 patients with a variety of cancers, including sarcomas and carcinomas, have been treated to date in the study. Following a total of 30 cycles of treatment, indibulin has been shown to be very well tolerated, with no drug-related Grade 2 or higher toxicities reported. Of note, no neurotoxicities, a common and serious side effect typically associated with microtubule targeting agents, have been observed.

In addition to confirming indibulin’s safety profile, this study evaluates early treatment responses by PET scans. Among 8 evaluable patients, these PET scans demonstrated a substantial anti-tumor effect by indibulin. Week seven PET scans identified one complete reduction in uptake, four with partial reduction in uptake, and three with increased uptake. Tumor responses measured by PET scan are generally referred to as metabolic responses, and usually correlate with treatment responses in cancer.

Sant Chawla, director, Sarcoma Oncology Center and a lead investigator of the study, said: “Oral indibulin has been very well tolerated, with none of the neurotoxicity or bone marrow suppression seen with taxanes and vinca alkaloids. Indibulin has also demonstrated promising early activity by PET scan, including a complete response in Ewing’s Sarcoma and a partial response in a neuroendocrine cancer. Taken together, these results are highly compelling, making ongoing study a priority.”