Project: 2B3-101 for the treatment of Glioma

2B3-101 for the treatment of Glioma

This is a summary of the request.

This submission concerns the product "glutathione pegylated liposomal doxorubicin hydrochloride (2B3-101)" for the indication "treatment of glioma".

At the time of submission of this application, no clinical trials in patients with glioma had been initiated.

Based on the proof of concept animal data with glutathione pegylated liposomal doxorubicin hydrochloride and the clinical experience with marketed doxorubicin pegylated liposomes (Caelyx), a 29 day intravenous dose-ranging studies (GLP) of 2B3-101 has started in the mouse and rat, as well as 29-day intravenous toxicity studies (GLP) of 2B3-101 in the mouse. These data will be sufficient to start a Phase I/II study in brain cancer patients at the end of 2010.

The initial clinical development program for 2B3-101 will comprise the following:

- A Phase I/II study to determine the maximum tolerated dose (MTD) in patients with advanced solid tumours with or without brain metastases, and to investigate the preliminary efficacy of the MTD in patients with primary brain tumors and brain metastases who relapsed after standard of care.

- A Phase I “translational” study in patients with (recurrent) malignant gliomas and metastatic brain tumors scheduled for debulking to determine the doxorubicin concentration in brain tumour tissue following the administration of 2B3-101.

The active substance of 2B3-101 is equivalent to the already marketed doxorubicin pegylated liposomes Caelyx. The ATC code for “doxorubicin hydrochloride” is L01DB01. However, when only focusing on 2B3-101, there currently is no regulatory status for glutathione pegylated liposomal doxorubicin hydrochloride; there are no clinical trial applications yet, no marketing application, no approval status in third countries, no previous applications of marketing authorization and no adverse regulatory actions that have been taken against glutathione pegylated liposomal doxorubicin hydrochloride.