NeoPharm posts promising glioma study data

The main objective of this study is to assess the safety and tolerability of cintredekin besudotox administered via convection enhanced delivery (CED) followed by radiation therapy (RT) with or without temozolomide (TMZ, marketed as Temodar by Schering-Plough Corporation) in patients with newly-diagnosed malignant glioma. The secondary objective is to determine the maximum-tolerated concentration, and the tertiary endpoint is to assess response to therapy as measured by overall survival.

Twelve patients have been enrolled in the study to date. Adverse events considered related to cintredekin besudotox were consistent with adverse events observed in phase I studies of cintredekin besudotox administered as monotherapy in patients with recurrent malignant glioma.

Based on the preliminary data, the investigators believe that CED of cintredekin besudotox followed by RT with or without TMZ offers promise as a feasible treatment regimen in patients with newly-diagnosed malignant glioma. The potentially next and final cohort of 0.5 microgram/mL cintredekin besudotox followed by RT and TMZ is anticipated to soon open for enrollment. Patients continue to be followed for survival which has extended at this time to beyond one year.

“The results to date of this phase I study of cintredekin besudotox provide preliminary support to the feasibility of future multimodality therapy consisting of surgery followed by cintredekin besudotox, radiation therapy and temozolomide in the treatment of newly diagnosed patients with malignant glioma,” commented Dr Michael Vogelbaum of the Cleveland Clinic Foundation.

“The study complements the ongoing phase III PRECISE clinical trial and provides initial evidence on the potential for broader utilization of cintredekin besudotox in the treatment of malignant glioma from initial diagnosis to recurrent disease,” he continued.