ZIOPHARM Oncology Inc. (NASDAQ:ZIOP) shareholders woke up to a nice 10% pop in the value of their shares, after the drug maker announced the receipt of positive guidance from an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) for its lead gene therapy product candidate, Ad-RTS-hIL-12 plus orally administered veledimex (V), to harness and control IL-12 production for the investigational treatment of recurrent glioblastoma (GBM), an aggressive form of brain cancer with few treatment options.
“We are pleased with our productive interactions with the FDA and the valuable direction we received at the End-of-Phase 2 meeting. Our controlled approach utilizing the RheoSwitch® platform represents the next-generation of gene therapy enabling IL-12 to be regulated through a transcriptional switch. We appreciate the FDA’s feedback surrounding our plans to advance Ad-RTS-hIL-12-based therapy to a pivotal registration study for patients with recurrent GBM in 2017 and look forward to establishing the benefits of this novel therapeutic approach,” said Laurence Cooper, M.D., Ph.D., Chief Executive Officer of ZIOPHARM.
“The median overall survival remains very promising and continues to be greater than 12 months for these heavily compromised patients,” said Francois Lebel, M.D., Chief Medical Officer of ZIOPHARM. He added, “After positive meetings with both FDA and European regulators, the Company is working towards finalization of the optimal pathway for our pivotal trial for Ad-RTS-hIL-12 + veledimex.”
In collaboration with its investigators and regulators, the Company is currently assessing its protocol design options for the pivotal trial, including the potential for a single-arm study comparing Ad-RTS-hIL-12 + V to historical controls in a subpopulation of patients with recurrent GBM. Details of the pivotal Phase 3 trial will be made available following evaluation and completion of discussions with clinical advisors as well as regulators.
On the ratings front, Ziopharm has been the subject of a number of recent research reports. In a report issued on February 27, Griffin analyst Keith Markey reiterated a Buy rating on ZIOP, with a price target of $23, which implies an upside of 291% from current levels. Separately, on January 11, J.P. Morgan’s Whitney Ijem maintained a Hold rating on the stock .
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Keith Markey and Whitney Ijem have a yearly average loss of 33.8% and 10.1% respectively. Markey has a success rate of 6% and is ranked #4463 out of 4554 analysts, while Ijem has a success rate of 40% and is ranked #3940.
ZIOPHARM Oncology, Inc. is a biopharmaceutical company currently in developmental stage that seeks to acquire, develop and commercialize, on its own or with commercial partners, a diverse portfolio of cancer therapies. It is focused on two clinical stage product candidates: Ad-RTS-IL-12 + veledimex and DC-RTS-IL-12 + veledimex.