Inovio Pharmaceuticals (NSDQ:INO) said today that the FDA placed a hold on its proposed Phase III clinical program for its investigational DNA immunotherapy candidate designed to treat pre-cancers and cancers caused by human papillomavirus.
The California-based company completed a randomized, double-blind Phase II trial of the candidate in July 2014, evaluating the DNA immunotherapy treatment in women with cervical intraepithelial neoplasia associated with HPV. The candidate met its efficacy endpoints, inducing regression of precancerous cervical disease and clearing HPV infection with robust T cell responses.
The plasmid DNA immunotherapy is injected intramuscularly, followed by electroporation using Inovio’s Cellectra delivery device. Cellectra uses a pulse of electricity to briefly open the pores in a cell’s membrane and introduce the DNA.
The Phase III study had not begun enrolling or dosing any subjects when it received word of the FDA’s hold. In initial communications with the company, the FDA requested more data to support the shelf-life of the disposable parts of the Cellectra device.
“Inovio is working diligently with the FDA to address its concerns and anticipates that the requested data will be available before the end of this year,” the company said.
Inovio anticipates picking up the Phase III program in the 1st half of 2017, pending resolution of the FDA’s requests. The company’s stock was trading at $6.97 apiece in mid-afternoon trading activity, down -16.6%.
