Ziopharm Reports Preliminary Efficacy Data From Phase I Cancer Trials
Ziopharm Oncology has reported positive data from two Phase I studies of indibulin, its novel, orally administered, synthetic tubulin targeted agent.
A total of 34 patients have been treated in the two Phase I studies (Phase I and Phase Ib), and safety, tolerability and early activity are being evaluated from varying doses and dose schedules.
To date, 24 patients have received at least two cycles of therapy and are evaluable for efficacy using Recist criteria. Of these, prolonged stable disease of greater than four months has been observed in 11 patients, with three of these patients reaching eight or more months to date.
In addition, early Pet scans have demonstrated one complete reduction in uptake, six with partial reduction in uptake, and four 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 of Sarcoma Oncology Center, Santa Monica, said: “Early data suggests that indibulin is clearly active in a number of cancers, and maintains a toxicity profile that distinguishes it from other tubulin binding agents such as the taxanes and vinca alkaloids.”