Concurrent with the clinical development of OXi4503, the following other programs are underway:
- Investigating the potential use of CA4P in immuno-oncology in combination with checkpoint inhibitors in preclinical models. This work is being conducted in collaboration with researchers at the University of Florida and the University of Arhus.
- A Phase 1b/2 (PAZOFOS – NCT02055690) clinical study of CA4P in combination with pazopanib, compared to pazopanib alone, in advanced recurrent ovarian cancer. The study is sponsored by The Christie Hospital NHS Foundation Trust and coordinated by the Manchester Academic Health Science Centre, Trials Coordination Unit, or MAHSC-CTU, with additional support from The University of Manchester, the Royal Marsden NHS Foundation Trust, and Mount Vernon Cancer Centre (part of the East and North Hertfordshire NHS Trust). The trial design consists of a Phase 1b dose escalation portion with the combination of pazopanib and CA4P, which was completed at the end of 2015, and a randomized Phase 2 portion comparing pazopanib alone and pazopanib plus CA4P in patients with recurrent ovarian cancer that is expected to initiate enrollment in mid 2016. The study is expected to enroll approximately 128 patients at sites in the United Kingdom. The primary endpoint of the trial is PFS, and secondary endpoints include safety, overall survival, objective response rate, and CA125 response rate. For more information please go to clinicaltrials.gov.
- Gastrointestinal and pancreatic neuroendocrine tumors (GI-NETs and PNETs) are highly vascularized tumors that cause a cascade of disease symptoms, resulting in significant morbidity for the patient. Preclinical data have evaluated the efficacy of systemic administration of CA4P for the treatment of functional insulinomas in a transgenic mouse model of PNETs. In the model, treatment with CA4P resulted in a significant and sustained decrease in circulating insulin, with maximum effect seen by day 17 (P<0.0001). Treatment with CA4P disrupted tumor vasculature, induced apoptosis and inhibited tumor cell proliferation, and appeared to be well tolerated, with no obvious toxicity.