Ziopharm Oncology Initiates Oral Indibulin Phase I/II Trial

Indibulin is a new, oral tubulin binding agent that targets both mitosis and cancer cell migration. It is expected to have several potential benefits, including oral dosing, application in multi-drug resistant tumors, no neuropathy, and minimal overall toxicity.

Ziopharm Oncology said that the Phase I trial is expected to enroll approximately 20 patients to determine the maximum tolerated dose of oral indibulin implementing the ‘mathematically modeled’ dose administration schedule – 5 days on and 9 days off – that capitalizes on the convenience of oral administration, but also maximizes drug activity, limiting potential toxicity and resistance.

The study is expected to implement a mathematically modeled drug administration schedule that was developed in preclinical studies by Larry Norton, as a consultant to Ziopharm Oncology. The model capitalises on the convenience and scheduling flexibility of oral administration to maximise anticancer activity, minimise potential toxicity and resistance, and exploit the drug’s mechanisms of action on both cancer cell division and cell movement.

Clifford Hudis, chief of the breast cancer medicine service at Memorial Sloan-Kettering Cancer Center, said: “The development of an additional new therapy for breast cancer that is effective but with fewer of the more significant side effects associated with many commonly used therapies would be an important step in the treatment of this disease. We look forward to testing this novel agent and dosing schedule in patients.”