NeoPharm phase 1 study suggests cintredekin besudotox effective in brain tumor patients

By Elaine Rigoli

Tampa, Fla., April 25 - NeoPharm, Inc. announced that, based upon a recent phase 1 study, evidence was provided that cintredekin besudotox (IL13-PE38QQR) appears to be safe and well tolerated in newly diagnosed malignant glioma patients.

The data suggests that cintredekin besudotox can be safely used in combination with two currently available therapies, radiation therapy and temozolomide, and that the combination may provide benefits for this patient population, officials said in a news release.

Patients in the study underwent a gross total resection of tumor followed by the placement of two to four stereotactically placed intraparenchymal catheters, and administration of cintredekin besudotox (0.25 ug/mL or 0.5 ug/mL) infused over 96 hours.

This was followed, 10 to 14 days later, by standard fractionated radiation therapy five days a week for six to seven weeks with or without temozolomide (75 mg twice a day, seven days a week during radiation).

Safety was assessed over an 11-week observation period following catheter placement.

Nineteen patients were enrolled and received cintredekin besudotox. Seventeen of 19 patients have completed treatment including cintredekin besudotox, radiation therapy plus/minus temozolomide.

No patients experienced dose-limiting toxicities in the first two cohorts. After one dose-limiting toxicity (seizure), the third cohort was expanded to six patients without any dose-limiting toxicities.

Three patients treated at 0.5 ug/mL plus radiation plus temozolomide have completed the safety observation without any dose-limiting toxicities.

Two additional patients are currently being treated and another one was recently enrolled to confirm the safety of 0.5 ug/mL plus radiation plus temozolomide.

Malignant glioma is the most common type of malignant primary brain tumor in adults, the release said.

NeoPharm, based in Waukegan, Ill., is a biopharmaceutical company dedicated to the research, development and commercialization of cancer drugs for therapeutic applications.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.