Australian-based biopharmaceutical firm EnGeneIC has begun dosing patients in a Phase I clinical trial of its EDV nanocells for the treatment of recurrent glioblastoma multiforme (GBM) within adults in the US.
EDV nanocells are bacterially derived cells designed as a nanoparticle drug, siRNA or miRNA delivery platform to destroy tumour cells, as well as induce the immune system's anti-tumour response.
The open-label, two-part Cerebral EDV Phase I trial will assess the nanocells in around 20 patients who have already received first-line chemotherapy.
EnGeneIC joint-chief executive officer and director Himanshu Brahmbhatt said: "The EDV nanocells bypass the blood brain barrier (BBB), get into the brain tumour via the tumour-associated leaky blood vessels and then deliver the toxic payload in therapeutically significant concentrations inside the cancer cells.
"This allows us to send potent drugs directly into brain cancer cells and in previous trials we have witnessed minimal to no toxicity in patients.
"We call our EDV platform a cyto-immuno-therapeutic, since it not only directly targets and kills cancer cells but also stimulates the patient's immune system to 'wake up' and fight the tumour."
The dose exploration part of the trial will evaluate the safety of multiple (EGFR)-EDV-doxorubicin doses at two dose levels, given once per week for seven weeks.
The trial's second part will establish the recommended Phase II dose of (EGFR)-EDV-doxorubicin.
The primary objective of the trial is to determine the safety of the therapy, while the secondary endpoints are measurement of anti-tumour response rates, overall survival, and the recommended Phase II dose determination.
The trial will also examine the biomarkers related to immunotherapy aspects of (EGFR)-EDV-doxorubicin.