Sydney-based EnGeneIC, a clinical stage biopharmaceutical company focused on developing the ED nanocell platform for the targeted delivery of cancer therapeutics, has announced that the US FDA has accepted the Company's investigational new drug application for using (EGFR)-EDVs loaded with doxorubicin in patients with recurrent glioma.
EnGeneIC said it intends to proceed with a Phase I study designed to evaluate its proprietary (EGFR)-EDV-dox for treating advanced glioma in patients who have exhausted all treatment options. The company expects to begin enrolling patients before the end of 2015.
Glioblastoma multiforme (GBM) is the most common primary malignant brain tumor in adults in the US, accounting for approximately 16 per cent of all primary brain tumors.
Despite an aggressive multimodal approach of surgery and chemotherapy and/or radiation, relapse is almost inevitable for patients with GBM - approximately 90 per cent recurrence rate.
The primary objective of the plannced Phase I study is to assess the safety of (EGFR)-EDV-dox in this patient population.
EnGeneIC said it will also assess the anti-tumor response according to Response Assessment in Neuro-Oncology criteria and overall survival of patients, as well as measure certain parameters of the adaptive immune response following administration with (EGFR)-EDV-dox.
According to the Joint-CEO of EnGeneIC, Dr Himanshu Brahmbhatt, "While we have shown our EDVs to be extremely well tolerated in first-in-man trials and have some recent exciting results in patients with mesothelioma, the FDA's acceptance of our three-component therapeutic, being a drug-loaded nanocell carrying a targeting antibody, is an extremely important step in our overall strategy of proving our cyto-immunotherapy platform has potential in intractable cancers like recurrent glioma. It also validates our tailored medicine approach to develop a pipeline of novel EDV-based therapeutics with different payloads for different cancers, allowing us to kill cancer cells as well as stimulate the immune system to effect dramatic improvements in overall survival."