ZIOPHARM Oncology, Inc.’s (NASDAQ:ZIOP) shares crashed 11.6% after the company announced the death of a patient in a phase I study on its lead candidate, Ad-RTS-hIL-12, for the treatment of recurrent or progressive glioblastoma (GBM) or grade III malignant glioma.
The cause of death was intracranial hemorrhage that occurred after the patient was discharged from the treatment center. Currently, the company is collecting and analyzing information to report to the FDA. Ziopharm also reported the death of two other patients in the study, although they were said to be unrelated to the candidate.
Meanwhile, ZIOPHARM continues to enroll patients in the phase I study. The company intends to discuss the next course of action with its safety review committee and would provide an update once a course of action has been determined.
We note that the phase I study is evaluating Ad-RTS-hIL-12, in combination with veledimex (orally administered), in late-stage recurrent GBM patients. The company is developing Ad-RTS-hIL-12 in collaboration with Intrexon Corporation (NYSE:XON) .
We remind investors that the Ad-RTS-hIL-12, in combination with veledimex, enjoys Orphan Drug designation in the U.S. for the treatment of patients with malignant glioma.
The combination is also being evaluated in a phase Ib/II study for the treatment of patients with locally advanced or metastatic breast cancer, following standard chemotherapy.
GBM, an aggressive brain tumor, is said to affect approximately 74,000 individuals each year, globally.
With limited available options for the treatment of glioblastoma and glioma, there is urgent need for new treatments in this field. Currently available drugs for the treatment of glioblastoma include Avastin, Tamodar and Gliadel.
Going forward, we expect investors to focus on pipeline updates from the company.
ZIOPHARM currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector include Merrimack Pharmaceuticals, Inc. (NASDAQ:MACK) and Innoviva, Inc. (NASDAQ:INVA) . Both stocks sport a Zacks Rank #1 (Strong Buy).
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