SOURCE: Apexian Pharmaceuticals

Apexian Pharmaceuticals

July 13, 2017 08:00 ET

Apexian Pharmaceuticals Announces FDA Agreement For Inclusion of Chemotherapy Induced Peripheral Neuropathy (CIPN) Indication Under Currently Approved IND

INDIANAPOLIS, IN --(Marketwired - July 13, 2017) - Apexian Pharmaceuticals, a clinical stage biotechnology company developing novel compounds to treat cancer, today announced that it has received FDA agreement that the currently approved IND can be used to examine Chemotherapy Induced Peripheral Neuropathy (CIPN) as an indication in addition to its anti-tumor effects.

APX3330, the lead molecule for Apexian has a dual biological role through the APE1/Ref1 protein. The IND was first approved on July 20, 2016 based on robust non-clinical data that had identified APE1 as a critical molecular "switch" controlling the activity of cancer regulatory proteins, including transcription factors HIF-1-alpha, AP-1, NF-kappa B, and STAT3. APE1/Ref1 protein also plays a critical role in the repair of DNA that has been damaged through oxidative mechanisms which are common with platinum-containing chemotherapy agents and robust non-clinical data demonstrating APX3330 prevents and/or reverses such damage is the basis for pursuing an indication for CIPN. Patent filings have been made on the use of APX3330 for this indication and Dr. Mark Kelley, Apexian's CSO, has received $2.9 M in NCI grants to further study the drug for prevention and recovery from this side effect which limits the use of several commercially available platinum-containing cancer drugs.

According to Rich Messmann, M.D. Apexian's Chief Medical Officer, "This attribute of APX3330 makes it an extremely attractive agent to be used in combination with approved platinum agents. It brings its own activity against cancer but extends the utility of other important drugs that are limited by the occurrence of CIPN."

Steve Carchedi, President and Chief Executive Officer of Apexian Pharmaceuticals, commented: "We are very excited to have received this affirmation from FDA indicating our preclinical data will enable us to study both of these indications within a single study. This really will leverage the investments being made to develop this new cancer drug."

About Apexian Pharmaceuticals
Apexian Pharmaceuticals is a clinical-stage biotechnology company focused on developing safe and effective therapy for patients with high unmet medical needs. Apexian's lead drug candidate is APX3330, an inhibitor of the APE1 protein, a critical node in cancer cell signaling. To learn more about Apexian Pharmaceuticals, please visit the company's website at www.ApexianPharma.com

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