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Rexahn Pharmaceuticals, Inc. (NYSE MKT: RNN) a clinical stage biopharmaceutical company developing best-in-class therapeutics for the treatment of cancer, is providing an update today on its three clinical development programs: RX-3117 (DNA synthesis inhibitor), Supinoxin™ (RX-5902, p68 RNA Helicase inhibitor), and Archexin
® (Akt-1 inhibitor). In addition to its three drug candidates in Phase I and Phase II trials, Rexahn has a portfolio of additional compounds, including three in pre-clinical studies.
Clinical Development Highlights:
RX-3117 IND Cleared with Phase I Clinical Trial to Begin in Q4 2013
The Investigational New Drug (IND) application for RX-3117 filed in July 2013 has now cleared the 30 day review period by the US Food and Drug Administration (FDA). Rexahn expects to initiate a Phase I clinical trial in cancer patients during the fourth quarter of 2013. Additionally, Rexahn will be exploring potential partnering opportunities with oncology focused pharmaceutical companies.
On August 28, 2013, Rexahn announced that Teva Pharmaceutical Industries did not exercise its option to license RX-3117, for strategic reasons. Teva had invested $9.1M in the development of RX-3117. According to Teva, “RX-3117 appears to have potential in various indications, but does not align with Teva’s new Oncology strategy.” As a result, Rexahn retains all development and commercial rights to RX-3117.
In August 2012, Rexahn reported the completion of an exploratory Phase I clinical trial of RX-3117 in cancer patients conducted in Europe, to investigate the oral bioavailability, safety and tolerability of the compound. In this study, oral administration of RX-3117 demonstrated an oral bioavailability of 56% and a plasma half-life (T
1/2) of 14 hours. In addition, RX-3117 was safe and well tolerated in all subjects throughout the dose range tested
Supinoxin™ (RX-5902) Phase I Clinical Trial in Progress
Enrollment in a Phase I clinical trial with Supinoxin™ (RX-5902) in cancer patients with solid tumors began in August. This trial is a multi-center study, designed to evaluate the safety, tolerability, dose-limiting toxicities and maximal tolerated dose (MTD) in patients with solid tumors. Rexahn anticipates updating investors on this Phase I trial in early 2014.