Angiochem has received fast-track and orphan drug designations from the US Food and Drug Association (FDA) for its Ang1005 product for treatment of glioblastoma multiforme.
Ang1005 is a paclitaxel-peptide drug conjugate that represents the first oncology product to leverage the low-density lipoprotein receptor-related protein 1 (LRP-1) pathway to cross the blood-brain barrier and enter cancer cells.
Angiochem CEO Dr Jean Paul Castaigne said: “These are important regulatory milestones for the programme. We will continue to work closely with the FDA as we advance Ang1005 through clinical development and the associated regulatory processes.”
Ang1005 has been studied in three clinical studies, which have included more than 200 patients.
In two Phase I studies, Ang1005 has demonstrated tolerability similar to paclitaxel and indications of activity. In a Phase II study, the drug demonstrated encouraging signs of anti-tumour activity.
Ang1005 is currently being studied in a Phase II clinical programme to further confirm the clinical activity of Ang1005 observed in these earlier studies, including a Phase II study in patients with primary brain cancers such as recurrent glioblastoma multiforme and anaplastic glioma and a Phase II study in HER2+ breast cancer patients.
Image: Coronal MRI with contrast of a glioblastoma WHO grade IV in a 15-year-old male. Photo: courtesy of Christaras A.