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US FDA lifts hold on Inovio's cancer vaccine trials after firm answers device questions

By Gareth MacDonald+

15-Jun-2017
Last updated on 16-Jun-2017 at 13:29 GMT2017-06-16T13:29:17Z

iStock/Ralwel
iStock/Ralwel

Inovio Pharmaceuticals has started Phase III trials of its DNA-based human papillomavirus therapy VGX-3100 after the US FDA lifted a clinical hold imposed list year.

The US drug firm started the clinical programme this week, explaining it had answered the US Food and Drug Administration's (FDA) questions about the Cellectra 5PSP device used to deliver VGX-3100.

VGX-3100 is a DNA vaccine designed to prevent pre-cancers and cancers caused by human papillomaviruses (HPV).

It consists of plasmids targeting the E6 and E7 proteins of HPV types 16 and 18.

The vaccine is administered by intramuscular injection. The Cellectra is a device applied to the injection site to encourage cells to take up the plasmids through a process called electroporation.

Electroporation involves applying controlled, millisecond electrical pulses to increase the permeability cell membrane.

Using the device Inovio claims to have increased levels of gene expression of ‘naked’ DNA vaccines by 100-fold compared to conventional injection.

Swiss drug manufacturer Roche licensed rights to the Cellectra technology in 2013 .

The FDA imposed the clinical hold in October after asking for data to support the shelf life of the disposable parts of the Cellectra 5pSp device.

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