SOURCE: Apex Therapeutics, Inc.

ApeX Therapeutics, Inc.

June 20, 2016 17:35 ET

ApeX Therapeutics Files IND to Initiate Phase 1 Study to Evaluate the Tolerability and Anti-Tumor Effects of APX3330

INDIANAPOLIS, IN--(Marketwired - June 20, 2016) - ApeX Therapeutics, a biotechnology company focused on developing novel compounds to treat cancer, today announced the filing of an Investigation New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to evaluate the tolerability and anti-tumor effects of the company's lead drug candidate, APX3330.

The initial portion of the phase 1 study will determine the maximum tolerated dose of APX3330 in a group of cancer patients with solid tumors refractory to existing treatments. Once the maximum tolerated dose is established, APX3330 will be evaluated in a cohort of patients with pancreatic ductal adenocarcinoma (PDAC), refractory to existing treatments.

Pancreatic ductal adenocarcinoma (PDAC) is the fourth leading cause of cancer-related death in the United States and is one of the few cancers for which survival has not improved substantially over nearly 40 years. Pancreatic cancer has the highest mortality rate of all major cancers; 94% of pancreatic cancer patients will die within five years of diagnosis (American Cancer Society: Cancer Facts & Figures 2014). Treatment with chemotherapy has not changed the natural course of this disease, and just recently, with combinations of chemotherapeutic agents, the median survival reached one year.

APX3330 is a small molecule that targets the redox effector factor-1 (Ref-1) protein which regulates the activation of oncogenic transcription factors. Ref-1 regulates multiple transcription factors involved in pancreatic cancer cell survival signaling including HIF-1alpha, AP-1, NFkappaB, and STAT3. High expression levels of Ref-1 also indicate decreased survival in PDAC as well as other cancers.

APX3330 has been shown in multiple in vitro and in vivo models of pancreatic cancer to be effective in reducing tumor growth and metastases as a single agent. In addition, APX3330 combined with a standard dose of gemcitabine demonstrated significant decreases in tumor volume compared to treatment by the respective drugs as single-agents.

Mark R. Kelley, PhD., Scientific Founder of ApeX Therapeutics and Betty and Earl Herr Chair in Pediatric Oncology Research and Professor of Biochemistry and Molecular Biology and Pharmacology and Toxicology at Indiana University School of Medicine, commented: "We are very excited to reach this important milestone and look forward to the evaluation of APX3330 in patients. We have evidence that APE1 is an important indicator of mortality in pancreatic cancer patients. Pending FDA acceptance of the IND submission and completion of fund raising, we will be ready to initiate the study."

About ApeX Therapeutics
ApeX Therapeutics is a biotechnology company focused on developing novel compounds to treat cancer targeting the multiple functions of the APE1 protein. The lead drug candidate, APX3330, initially targets pancreatic cancer and is expected to begin clinical studies in 2016. To learn more about ApeX Therapeutics, please visit the Company's website at www.apextherapeutics.com

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