Dive Brief:
- Ziopharm Oncology announced Friday that a patient had died as part of their phase 1 study of a brain tumor gene therapy, 15 days after the therapy was injected. The incident, however, was not initially reported to the FDA, but disclosed in a bullet point during a medical presentation that was made public through SEC filings, The Street reports.
- The company had been attempting to raise up to $50 million in a stock offering via Jefferies & Co. throughout the week, according to The Street. But when the bank heard about the ill-announced third patient's death, the deal was apparently abandoned.
- Participating investors received news of the deal's cancelation at roughly 4 PM Thursday, and TheStreet broke the news shortly after, prompting Ziopharm's stock to open low on Friday after a 15% fall in after hours
Dive Insight:
Ziopharm's phase 1 gene therapy candidate is designed to treat late-stage, recurrent Glioblastoma, an aggressive brain tumor that afflicts roughly 74,000 people and with a 3% survival rate, according to the company.
Two other phase 1 study patients had passed away 3.9 months and 6.7 months after the treatment, but for reasons unrelated to the study, the company stated in their press release. And while they confirmed the third death, Ziopharm said they were still analyzing their information in order to "properly and timely report it to the FDA."
"This is an isolated case, and there have been no reported related instances of brain hemorrhage in any pervious cohort or prior studies with Ad-RTS-hIL-12 + veledimex," the company added. Enrollment is still open for the phase 1 study.
Regardless of the indication, a clinically-induced death is still a warning sign for investors. And the death in Ziopharm's story could play on safety concerns for the cell therapy space after Juno Therapeutics reported four deaths associated with its CAR-T trial. That trial is testing a different technology than Ziopharm's but also seeks to boost the immune system's ability to attack cancers.