A brain cancer patient died from bleeding in the skull soon after being injected with a Ziopharm Oncology (ZIOP) gene therapy directly into the brain tumor.
The Ziopharm patient, diagnosed with a recurrent brain tumor, was treated with the company's experimental gene therapy, known as Ad-RTS-hIL-12. The gene therapy, which is supposed to stimulate a tumor-killing immune response, is injected directly into the patient's tumor. Fifteen days after the Ziopharm gene therapy injection, the patient died from an intracranial hemorrhage.
Ziopharm CEO Laurence Cooper first disclosed the patient death -- which occurred as part of an ongoing clinical trial -- during a presentation at a closed-door scientific workshop in Washington, D.C., on Thursday. Cooper's presentation slides, which included a single bullet point about the patient death, were attached to an 8-K filed Thursday night with the Securities and Exchange Commission.
Ziopharm spokesman David Pitts confirmed the never-before-disclosed death but says the company does not believe the injection of Ad-RTS-hIL-12 into the patient's skull was responsible for the fatal bleeding episode.
However, Pitts concedes that more information about the patient and his fatal skull bleed is still being collected. The FDA has not yet been told about the death.
"This event has just been reported to us and we are following protocol in collecting and analyzing information in order to properly report it to the FDA," said Pitts.
The death of a second patient enrolled in the Ziopharm gene therapy study was also disclosed for the first time Thursday. That patient died 3.9 months following treatment for an undisclosed reason, but unrelated to Ad-RTS-hIL-12, the company says.
The circumstances surrounding the Ziopharm patient deaths come amid heightened scrutiny of experimental anti-cancer therapies. Last week, two blood cancer patients died from treatment with an unapproved CAR-T cellular therapy from Juno Therapeutics.
Ziopharm was trying to raise as much as $50 million in a stock offering this week, but the deal was abandoned Thursday night, according to an email sent by bankers from the investment bank Jefferies & Co. to a prospective investor in the deal. That investor forwarded the Jefferies email to TheStreet.
Concerns about the patient death and the way Ziopharm disclosed it scuttled the stock sale, a second investor source told TheStreet.
"We don't comment on any of the company's confidential activities," said Ziopharm spokesman Pitts.