Apexian Pharmaceuticals Announces FDA Acceptance of Phase 1 Protocol to Include Biomarker Measurements and Evaluate the Tolerability and Anti-Tumor Effects of APX3330

Indianapolis, IN  – Apexian Pharmaceuticals, a clinical stage biotechnology company developing novel compounds to treat cancer, today announced that it has received FDA authorization to initiate the Phase 1 study of its lead compound APX3330, an inhibitor of the APE1 protein. APE1, when found at high levels in patients with advanced cancer, correlates with decreased overall survival.

Leveraging the wealth of pre-clinical data that has identified APE1 as a critical molecular “switch” that controls the activity of cancer regulatory proteins, including transcription factors HIF-1-alpha, AP-1, NF-kappa B, and STAT3, the study has been designed to affirm the safety of APX3330 in cancer patients, to measure the drug’s inhibitory effect upon the APE1 protein, as well as to confirm APX3330 ability to disrupt cancer cell signaling.

Patients that are eligible for the study will receive oral doses of APX3330 and undergo regular safety assessments as well as CT imaging to identify evidence of anti-tumor effect.

According to Rich Messmann, M.D. Apexian’s Chief Medical Officer, “This study includes a robust assessment of APX3330 anti-cancer activity, including analysis of biomarkers such as APE1 protein levels, RNA-sequencing assays, and the evaluation of circulating tumor cells, all of which will provide insight into the characteristics of patients most likely to benefit from treatment with APX3330.”

Steve Carchedi, President and Chief Executive Officer of Apexian Pharmaceuticals, commented: “We are very excited to have reached this important milestone in the evaluation of APX3330 in patients with cancer and will begin study accrual in the coming months.”

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

Media Contact:
Email: PR@Apexianpharma.com
Telephone: 844-463-3330 x113

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