ZIOPHARM Oncology Inc. (NASDAQ:ZIOP) has announced that it completed enrolling 36 patients in its phase 2 clinical trial designed to evaluate a drug combo between Ad-RTS-hIL-12 and Libtayo.
The company revealed that the Phase 2 clinical trial will investigate the drug combination of Ad-RTS-hIL-12 with veledimex will be combined with Libtayo. The latter is a PD-1 inhibitor that is also known as cemiplimab-rwlc. The researchers aim to investigate whether the drug combo will be effective in treating patients suffering from progressive or recurrent glioblastoma (rGBM). The company was pleased to announce that it enrolled the targeted 36 patients it required for the study.
“Achieving this milestone reinforces the critical need for new treatments for rGBM and highlights the optimism from the clinical community for the potential of Controlled IL-12,” stated Laurence Cooper, the CEO of Ziopharm.
The CEO also expressed gratitude to healthcare workers and clinicians that have been involved in oncology patient care, whose contributions were vital for the development of the Controlled IL-12 program. The company developed Controlled IL-12 as a developmental gene therapy that aims to control or induce interleukin 12 (hIL-12) production in human subjects. Interleukin 12 is a vital component for optimal regulation of the immune system.
Previous studies involving Controlled IL-12 have yielded favorable findings
Positive findings from previous clinical trials influenced the decision to conduct a clinical trial involving the drug combo. The data was published in the Science Translational Medicine journal. Serial data collected from rGBM patients treated with Controlled IL-12 showed good regulation of PD-1 expression and an increase in the number of activated T-cells.
Ziopharm also presented data from the Phase 1 trial at this year’s American Society of Clinical Oncology (ASCO) event, which was held virtually due to the ongoing coronavirus pandemic. The findings from the study demonstrated a noteworthy safety profile and decent efficacy against tumors. The data also supports the advancement of the research to the next step, the phase 2 clinical trial for which the company recently finalized patient enrollment. Ziopharm is optimistic about the findings from the phase 2 study.