Here’s ZioPharma’s press release (abbreviated somewhat) that caused it to rise almost 14% yesterday.
It announced the receipt of positive guidance from an End-of-Phase 2 meeting with the FDA for its lead gene therapy 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 the valuable direction we received at the End-of-Phase 2 meeting. Our controlled approach using the RheoSwitch platform represents the next-generation of gene therapy enabling IL-12 to be regulated through a switch. We appreciate the FDA’s feedback on our plans to advance Ad-RTS-hIL-12-based therapy to a pivotal study for patients with recurrent GBM in 2017 and look forward to establishing the benefits of this novel therapeutic approach.
The median overall survival remains very promising and continues to be greater than 12 months for these heavily compromised patients. After positive meetings with both FDA and European regulators, we are working to finalize the optimal pathway for our pivotal trial.
In collaboration with its investigators and regulators, we are 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…
Remember to not get overly excited. They still don’t have a marketable product and won’t for some time, and they are still burning cash. It would be wise to keep your position small if you decide to take one.