APE1/Ref-1 is a dual function protein that governs the redox regulation of transcription factors effecting critical aspects of cancer cell survival and growth including HIF-1a, STAT3, NF-KB, and others, while also protecting neurons through its ability to prevent and repair oxidative DNA damage caused by chemotherapy.
Apexian’s lead drug APX3330 provides anti-tumor effect through its highly selective inhibition of the APE1/Ref-1 protein’s redox function while simultaneously protecting against chemotherapy induced peripheral neuropathy (CIPN), a condition that effects many cancer patients, and for which there is no effective therapy. Both functions have been confirmed in multiple state-of-the-art preclinical models. Additionally, APX3330 is an orally-administered drug that was shown to be safe in prior clinical studies by Eisai Pharmaceuticals, who sought to develop APX3330 in a non-cancer indication.
Apexian has now received agreement for the U.S. Food and Drug Administration to allow joint development of APX3330 as both a targeted anti-cancer agent as well as a neuroprotective anti-CIPN agent under the same IND, allowing for joint co-development and clinical testing.
A Phase I human clinical trial evaluating APX3330 in cancer patients with advanced solid tumors will commence in late 2017. Please see http://www.clinicaltrials.gov/ for additional information regarding APX3330.