AIM ImmunoTech Inc (NYSE:AIM) has announced positive data from a Phase 1/2 study of intraperitoneal chemo-immunotherapy in advanced recurrent ovarian cancer.
The study has been published in the American Association for Cancer Research publication, Clinical Cancer Research under the title, 'Phase I trial combining chemokine-targeting with loco-regional chemo-immunotherapy for recurrent, platinum-sensitive ovarian cancer shows induction of CXCR3 ligands and markers of type 1 immunity'.
The Phase 1/2 study, conducted by the University of Pittsburgh School of Medicine, is designed to evaluate the immunologic and potential clinical effectiveness of intensive locoregional sequential intraperitoneal (IP) cisplatin (IPC) with intravenous (iv) paclitaxel followed by peritoneal infusion of a chemokine modulatory (CKM) regimen composed of a cocktail of IP rintatolimod and interferon-alpha (IFNα) for patients with advanced stage ovarian cancer (III-IV) at primary neoadjuvant setting.
READ: AIM ImmunoTech’s Ampligen safety data presented at Eighth European Scientific Working Group on Influenza
AIM ImmunoTech provided rintatolimod - Ampligen, a dsRNA acting as toll-like receptor 3 (TLR3) agonist - for the Phase 1/2 study.
Thomas Equels, chief executive officer of AIM ImmunoTech, said: “Ampligen has demonstrated broad immunological effects and we believe has the potential to be a key component in the treatment of ovarian cancer. We are grateful to the University of Pittsburg School of Medicine and are excited to provide support for a larger Phase 2 study which we believe has the potential to provide hope for patients and their families, as well as drive significant shareholder value.”
“These results represent an important extension of prior studies using human tumor explants that showed Ampligen’s potentially important role as a TLR3 (toll-like receptor 3) agonist acting synergistically with high-dose interferon-alpha (IFNα) and celecoxib to selectively enhance Teff cell-attractants while suppressing Treg-attractants in the tumor microenvironment with a concomitant increase in the Teff/Treg ratio,” said David Strayer, chief medical officer of the company.
He added: “This current study shows that similar findings are seen combining Ampligen with chemokine-targeting and chemo-immunotherapy in patients being treated for recurrent ovarian cancer.”
Strayer noted that the importance of boosting the Teff/Treg ratio in the tumor microenvironment is that it is associated with the conversion of ‘cold’ tumors into ‘hot’ tumors, which have an increased sensitivity to chemo-immunotherapy and an improved chance of showing tumor regression.
Twelve patients were enrolled in the Phase 1 portion of the trial and were treated with IP cisplatin, IP Ampligen, and oral celecoxib (COX-2 blocker).
The primary objectives of the study were to evaluate safety, identify Phase 2 recommended dose and characterize changes in the immune TME.
“Epithelial ovarian cancer, the most common form of ovarian cancer, is the most aggressive gynecologic cancer and despite aggressive surgery and chemotherapy treatment options, the 5-year survival rate for patients with advanced high grade serous ovarian cancer remains low,” said Robert P Edwards, chairman, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh School of Medicine, Director of Women’s Health for UPMC. “I am very encouraged by the results from this study.”
Based on these encouraging results, AIM ImmunoTech plans on supporting a follow-up Phase 2 trial that will specifically define the immunologic and clinical efficacy of tumor loaded αDC1 vaccine in conjunction with the cisplatin/chemokine modulatory combination regimen.