“This safety data is very encouraging and supports the potential for Cintredekin Besudotox delivered via Convection-Enhanced Delivery as a safe treatment option for patients with malignant glioma at initial diagnosis,” said Michael Vogelbaum, vice chairman and associate director of neurosurgical oncology in the Brain Tumor Institute at Cleveland Clinic Foundation.
The phase I trial evaluated the safety and tolerability of Cintredekin Besudotox delivered via convection enhanced delivery (CED) followed by treatment with external beam radiation therapy (EBRT) alone or EBRT plus temozolomide in patients with newly diagnosed malignant glioma following tumor resection. CED of Cintredekin Besudotox at the highest dose followed by EBRT with or without concurrent temozolomide was shown to be well-tolerated in patients.
“Along with the growing body of clinical evidence from our earlier phase I/II studies in the recurrent patient population, this study allows for the potential expansion of Cintredekin Besudotox to newly-diagnosed patients,” said Guillermo Herrera, president and CEO of Neopharm.
“We are expecting that the phase II trial in newly diagnosed patients will begin in the first half of next year.”