Rexahn Pharmaceuticals Inc. (NYSE MKT: RNN) is a clinical stage biopharmaceutical company focused on developing best-in-class therapeutics for the treatment of cancer. Rexahn’s clinical development programs directly target specific proteins that are selectively expressed in human cancer cells, resulting in increased efficacy and reduced toxicity. In preclinical studies these drug candidates are effective against multiple drug resistant cancers and have shown to increase the effectiveness of various FDA approved cancer treatments. Rexahn is also developing specific biomarker tests that will help identify which patients will be most responsive to its treatments. The Company’s nanotechnology-based drug delivery system has shown it can make FDA approved chemotherapy drugs more effective.
Our clinical development pipeline consists of three novel compounds:
SupinoxinTM (RX-5902) SupinoxinTM is an orally administered first-in-class small molecule that inhibits the growth of multiple types of human cancer cells through inhibition of phosphorylated p68 which is selectively expressed in cancer cells. Preclinical studies to date have shown SupinoxinTM to be effective in blocking tumor progression and metastasis for melanoma, cancers of the ovary, kidney and pancreas. A Phase I clinical trial with SupinoxinTM in cancer patients with solid tumors began in August 2013. This trial is a multi-center study, designed to evaluate the safety, tolerability, and maximal tolerated dose (MTD) and preliminary efficacy in patients with solid tumors.
RX-3117 RX-3117 is a next generation cancer cell specific nucleoside that inhibits DNA and RNA synthesis and induces apoptotic cell death by a mechanism distinct from existing non-selective nucleoside drugs currently used to treat cancer patients. Preclinical studies have shown RX-3117 to be effective in inhibiting the growth of solid tumors in the pancreas, lung, colon, kidney and others and to be effective in gemcitabine resistant cancer cell lines. An exploratory Phase I clinical trial in cancer patients was conducted in Europe in 2012 and demonstrated that RX-3117 is orally bioavailable with no reported adverse events were reported over the dose range tested. Rexahn initiated a Phase Ib clinical trial in cancer patients with solid tumors in January 2014.
Archexin® Archexin® is a unique anti-cancer drug candidate which inhibits the activated form of the cancer cell signaling protein phosphorylated-Akt1 which is only found in cancer cells and is involved in cancer cell growth, survival, angiogenesis, and drug resistance. Archexin has completed a Phase I clinical trial in cancer patients and was shown to be safe and well tolerated. The dose-limiting toxicity was grade 3 fatigue. In a small Phase IIa trial in advanced pancreatic cancer patients, Archexin in combination with gemcitabine was shown to be safe and well tolerated and demonstrated a preliminary efficacy signal with a median survival of 9.1 months. Rexahn initiated an additional Phase IIa clinical trial for Archexin in combination with everolimus to treat cancer patients with metastatic renal cell carcinoma in January 2014.
These clinical development programs are part of a growing oncology drug pipeline that consists of highly differentiated and exciting anti-cancer compounds.
Our strategy is to continue building a significant clinical development pipeline of innovative therapies that we will commercialize on our own or with other pharmaceutical partners. Rexahn’s powerful discovery engine and differentiated product pipeline provide the opportunity for a high value generating biopharmaceutical company.