Rexahn Pharmaceuticals, Inc., a clinical stage biopharmaceutical company developing best-in-class therapeutics for the treatment of cancer, today announced that its drug candidate RX-21101 was selected by the National Cancer Institute's (NCI) Nanotechnology Characterization Laboratory (NCL) for its preclinical characterization program to help facilitate the advance of RX-21101 towards human clinical trials.
RX-21101 is a polymer conjugated form of docetaxel that contains a signaling moiety which directs the drug into the tumor. This approach may maximize the level of docetaxel in the tumor and may minimize the level of freely circulating docetaxel in the body, which may result in increased anti-tumor activity and a reduction of adverse events.
NCI developed the NCL to facilitate the translation of promising nanotechnology-based therapeutics for the treatment of cancer, working in concert with the National Institute of Standards and Technology (NIST) and the U.S. Food and Drug Administration (FDA). NCL will conduct an extensive series of preclinical studies on RX-21101 including physiochemical characterization, in-vitro cytotoxicity/hematology/immunology studies, and in vivo rodent pharmacokinetic studies. These studies, together with the additional work being performed by Rexahn scientists, will provide the foundation for filing an investigational new drug (IND) application to start Phase I clinical testing.
"We are very pleased that NCI selected RX-21101 for its NCL program. We believe RX-21101 holds the potential to address the patient population currently being treated with docetaxel in a manner that offers higher efficacy with reduced systemic side effects. Rexahn welcomes the opportunity to work with NCI to advance RX-21101 toward clinical development," commented Rexahn's CEO, Peter D. Suzdak, Ph.D.
RX-21101 is a polymer conjugated form of docetaxel (a common chemotherapy agent that is now generic but is marketed worldwide under the trade name Taxotere® and had annual sales of $3.1 billion when still under patent) that contains a signaling moiety which directs the drug into the tumor. Docetaxel is used in the treatment of breast, ovarian, prostate, and non-small cell lung cancer. Despite its commercial success, docetaxel is toxic to all dividing cells in the body and is associated with a high incidence of adverse events including anemia, infection, fever, neutropenia, neuropathy, asthenia, edema, alopecia, nausea and vomiting. These adverse events are the result of high concentrations of free docetaxel in the blood.
RX-21101 was developed using the Nano-Polymer-Drug Conjugate Systems (NPDCS) platform jointly discovered with the University of Maryland at Baltimore. This technology targets the delivery of docetaxel directly into cancerous tumors. The direct delivery of chemotherapeutic drugs into the tumors has been shown to result in increased efficacy and reduced toxicity in preclinical studies. The NPDCS platform combines existing chemotherapeutic agents with a proprietary polymer carrier that contains a signaling moiety which directs the drug into the tumor. This approach minimizes the levels of freely circulating anti-cancer agents in the body, which has the potential to dramatically reduce potential adverse events, and maximize anti-tumor activity by accumulating the anticancer agent in the cancer tumor. NPDCS is a broad platform that has the potential to generate multiple development candidates going forward.