By: ApeX Therapeutics, Inc. via Marketwired News Releases
July 20, 2016 at 08:00 AM EDT
ApeX Therapeutics Announces FDA Acceptance of IND to Evaluate the Tolerability and Anti-Tumor Effects of APX3330
INDIANAPOLIS, IN–(Marketwired – July 20, 2016) – ApeX Therapeutics, a biotechnology company focused on developing novel compounds to treat cancer, today announced the acceptance of an Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for clinical testing of the company’s lead drug candidate, APX3330 in pancreatic cancer.
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 2015). 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 have reached this very important milestone to evaluate APX3330 in patients with pancreatic cancer. We are now poised to initiate the study in the coming months.”