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About Us

DNA Repair in Cancer Therapy: Molecular Targets and Clinical Applications. Kelley, M., and Fishel M. Ed. Academic Press/Elsevier

Apexian Pharmaceuticals is an emerging clinical stage biotechnology company founded on the scientific discoveries of Dr. Mark R. Kelley, whose groundbreaking work on APE1/Ref-1 redox protein signaling at the Indiana University School of Medicine has provided unique insight into this important biological target.  Dr. Kelley’s research, and the research of other scientists worldwide, has shown that inhibitors of APE1/Ref-1 redox signaling affect numerous transcription factors involved in cancer cell signaling and survival.

Apexian has leveraged this deep scientific expertise to discover molecules that target and inhibit the APE1/Ref-1 redox signaling and DNA repair protein pathway with high specificity. Our lead molecule – APX3330 – is representative of this novel class of compounds and has shown single-agent efficacy in pre-clinical cancer models; colon, bladder, pancreatic, prostate and AML. Additionally, pre-clinical studies indicate that APX3330 is synergistic with a number of chemotherapeutic agents while providing evidence of a neuro-protective, anti-chemotherapy induced peripheral neuropathy (CIPN) effect.

The preliminary testing of human safety and non-cancer efficacy of APX3330 was established by Eisai Pharmaceuticals in a previously conducted development program targeting chronic liver diseases, where the compound was safely administered in over 10 clinical trials to more than 400 patients, across a variety of doses.  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. 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. A Phase I human clinical trial evaluating APX3330 in cancer patients with advanced solid tumors is now nearing completion and results will be reported at major medical conferences in early 2019. The neuroprotective activity of APX3330 has garnered the interest of patients, physicians and research scientists worldwide and additional studies that will begin accrual in mid- to late-2019 evaluating the potential benefit of APX3330 in patients receiving platinum-based chemotherapy. Information on APX3330 clinical studies will be posted at http://www.clinicaltrials.gov/.