The Phase I oncology study of
APX3330 is approved to begin by FDA

Clinical Program

actual drug product to be used in clinical trial
actual drug product to be used in clinical trial

Background
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.

Status
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.