Inovio Pharmaceuticals ($INO) has been stopped before it started as its planned Phase III trial of an experimental therapy designed to eliminate precancerous cervical lesions was halted this morning by the FDA.
In a brief update, Inovio said the U.S. regulator “has placed a clinical hold on its proposed Phase III clinical program for VGX-3100,” with the FDA apparently concerned about the shelf-life of the newly designed and manufactured disposable parts of the Cellectra 5PSP immunotherapy delivery device.
It wants additional data to support the trial, according to a statement from the biotech, which Inovio believes will push back the start of the late-stage test into the first half of next year.
“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 in a statement.
Back in 2014, the biotech released data showing its experimental med had hit its primary endpoint, but the tests have proven controversial with some, such as the TheStreet’s Adam Feuerstein, saying it had only won out by spinning the data.
Time has not dampened his feelings on the drug, saying today on Twitter: “INO--great work once again, guys. Let’s recall, ph2 study of ‘3100 finished late '14. Nearing end ’16, ph3 not started, now on FDA hold.”
Its shares dropped by more than 14% premarket on the news.