Apexian Pharmaceuticals Opens Phase I Clinical Study of APX3330 in Patients with Solid Tumors

 Apexian Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, has announced the opening of a clinical trial for patients with advanced solid tumors. The study involves APX3330, a first in class orally administered inhibitor of APE1/Ref 1, a dual-function protein that plays a critical role in promoting and maintaining a broad variety of cancers. Details of the study, including eligibility criteria, the location of participating clinical centers and referral contact information can be found at www.ClinicalTrials.gov, a website maintained by the National Institutes of Health.

The APE1/Ref-1 protein regulates the activity of other cancer-associated proteins, including transcription factors HIF-1-alpha, AP-1, NF-kappa B, and STAT3; proteins that control the aggressiveness of many cancers. Data indicates that Apexian’s drug APX3330 inhibits the cancer-promoting activity of APE1/Ref-1 without causing the side effects normally associated with many types of chemotherapy. Additionally, in a variety of pre-clinical studies APX3330 has been shown to not only have an anti-cancer effect, but to also prevent, and reverse the nerve damage caused by certain forms of chemotherapy.

The clinical study is the first to explore APX3330 use in patients with advanced cancer, and is the culmination of extensive research on APE1/Ref-1 and APX3330 conducted by Dr. Mark Kelley, Professor and Associate Director of Basic Science Research at Indiana University’s Simon Cancer Center as well as other scientists worldwide. Dr. Kelley’s work on APE1/Ref-1 and APX3330 has previously resulted in significant research grants provided through the National Cancer Institute in order to explore APX3330’s potential to benefit cancer patients.

According to Dr. Richard Messmann, Apexian’s Chief Medical Officer, "Apexian’s research has provided us with a clear path to understanding, and an ability to measure, the clinical benefit that may be obtained when cancer patients are treated with APX3330. It also lays the foundation for determining whether patients with chemotherapy-induced peripheral neuropathy (CIPN) may benefit when receiving APX3330. The clinicians involved in the study, including those at the Simon Cancer Center and at START SA (San Antonio, TX) and START Midwest (Grand Rapids, MI) have uniformly expressed excitement regarding their participation in the study."

"The initiation of the APX3330 study is a significant step forward in Apexian’s mission to develop safe and effective treatments for cancer patients," said Steve Carchedi, President and CEO of Apexian Pharmaceuticals. "Despite recent advancements in cancer treatments, there continues to be a need for treatments that improve the survival of cancer patients. Apexian is committed to 'moving mountains' to help these patients."

About Apexian Pharmaceuticals

Apexian Pharmaceuticals’ mission is to develop safe and effective therapy for patients with high unmet medical needs. Apexian’s lead drug candidate is APX3330, with additional promising agents in their drug-development pipeline