Ziopharm Oncology has commenced a Phase II study of Ad-RTS IL-12 in combination with palifosfamide for the treatment of non-resectable recurrent or metastatic breast cancer.
The multi-centre US study is expected to enrol 68 non-resectable, recurrent or metastatic breast cancer patients with visible lesions or lesions accessible by injection.
Mary Crowley Medical Research Center executive medical director and lead investigator Dr John Nemunaitis said the immune system is assumed to play a vital role in restraining both cancer's growth and metastasis and various cancer treatment advancements are based on this assumption.
"For breast cancer, the positive correlation of survival with immune response in the tumor elicited by non-immune treatments has only recently been elucidated, and this understanding hints at the potential for exciting new breakthroughs in this still underserved population," Nemunaitis said.
"We look forward to participating in this study and to gaining further insight regarding the combined effect of Ad-RTS IL-12, a selectively controlled immunotherapy, and palifosfamide, a potent bi-functional DNA alkylating agent."
The study, which consists of two parts, will evaluate the safety and efficacy of Ad-RTS IL-12 and palifosfamide in combination and separately.
The first part will assess the safety of Ad-RTS IL-12 and palifosfamide, alone or in combination, while part two will assess the efficacy of the Ad-RTS IL-12-only arm and the combination arm.
The rate of progression-free survival at 16 weeks is the primary endpoint, while secondary endpoints comprise objective response rate, duration of response and evaluation of pharmacodynamic tumour markers.
Ziopharm chief executive officer Dr Jonathan Lewis said; "Building on preclinical work supporting a synergistic effect between Ad-RTS IL-12 and palifosfamide, and the clinical findings from our ongoing Phase II melanoma study, we believe the combination of Ad-RTS IL-12 and palifosfamide has the potential to be quite impactful in breast cancer."