Advanced cancer patients whose disease has failed to respond to existing therapies or where no approved therapy is available are expected to be enrolled in the studies. The purpose of the dose escalation studies will be to evaluate the pharmacokinetics and safety of Panzem NCD, the next generation formulation of Panzem (2-methoxyestradiol or 2ME2).
2ME2 is an orally active small molecule that attacks tumor cells through multiple mechanisms of action and blocks the development of new blood vessels that feed tumor cells. Panzem NCD, an oral liquid formulation, has been shown in pre-clinical studies to significantly increase the drug’s bioavailability, which is expected to result in enhanced drug levels of 2ME2 in patients.
“Valuable safety, pharmacokinetic and dosing information will be obtained from this study, which will enable us to move aggressively into the next stages of clinical testing focusing on specific tumor types and combinations with approved treatments,” explained said Dr Carolyn Sidor, EntreMed’s vice president and chief medical officer.
“One of the key attributes of next generation cancer treatments will be drug candidates like Panzem that affect multiple cellular pathways thereby limiting drug resistance,” she concluded.
In previous phase II studies in more than 165 cancer patients, Panzem capsules showed evidence of clinical efficacy, including one partial response and several patients with stable disease. Panzem capsules were also tested clinically in combination with Sanofi-Aventis’ Taxotere in advanced breast cancer patients resulting in an objective response rate of 20% with no added toxicities.