EnGeneIC doses first patient in Phase 1 study

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EnGeneIC has begun dosing patients in a US-based open-label Phase 1 clinical trial evaluating its proprietary EDV(TM) nanocells to treat recurrent glioblastoma multiforme (GBM) in adults.

GBM is the most common primary malignant brain tumour in adults in the US, accounting for approximately 16 per cent of all primary brain tumours. These patients almost invariably relapse and there are few treatment options available for recurrent GBM.

Dr Himanshu Brahmbhatt, joint-CEO and Director of EnGeneIC, said: "The Cerebral EDV study is a very exciting trial since for several decades the blood brain barrier (BBB) has been thought to be the limiting factor in allowing anti-tumour drugs to safely get to brain tumor cells. The EDV nanocells bypass the 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 open-label Phase 1 Cerebral EDV study is a two-part clinical trial in approximately 20 adults diagnosed with recurrent GBM who have already received first-line chemotherapy.

The first part of the study, which will be a dose exploration study, will assess the safety of multiple doses of (EGFR)-EDV-doxorubicin at two dose levels, administered once a week for 7 weeks. The second part of the study will provide guidance on the recommended Phase 2 dose of (EGFR)-EDV-doxorubicin.

The company said the primary objective of the study is to assess the safety of the therapy, while secondary endpoints include assessing anti-tumour response rates and overall survival, as well as to identify the recommended Phase 2 dose. In addition, the study will assess biomarkers associated with immunotherapy aspects of (EGFR)-EDV-doxorubicin.