Rexahn Pharmaceuticals, Inc., a development stage biopharmaceutical company, is engaged in the discovery, development, and commercialization of treatments for cancer and other medical needs. The company’s pipeline features one oncology candidate in Phase II clinical trials, two oncology candidates in Phase I clinical trials, two drug candidates that are not being actively developed and other drug candidates in pre-clinical development. Drug Candidates The company’s three clinical stage drug candidates in active development are Archexin, RX-3117 and Supinoxin (RX-5902). Archexin is a potential best-in-class, potent inhibitor of the protein kinase Akt, which plays critical roles in cancer cell proliferation, survival, angiogenesis, metastasis and drug resistance. Archexin has received ‘orphan drug’ designation from the U.S. Food and Drug Administration (FDA) for renal cell carcinoma (RCC), glioblastoma, ovarian cancer, stomach cancer and pancreatic cancer. The company has completed a Phase IIa clinical trial for Archexin for the treatment of pancreatic cancer, and in 2014, the company initiated a Phase IIa proof-of-concept clinical trial to study Archexin’s safety and efficacy in patients with metastatic RCC. RX-3117 is a small molecule nucleoside compound with an anti-metabolite mechanism of action. The company completed an exploratory Phase I clinical study for RX-3117 in 2012 that demonstrated the oral bioavailability of RX-3117 in humans with no adverse effects reported. In 2014, the company initiated a Phase Ib clinical trial to study the safety and efficacy of RX-3117 in patients with solid tumors. Supinoxin, or RX-5902, is a first-in-class small molecule that inhibits the phosphorylation of p68 RNA helicase, a protein that plays a role in cancer growth, progression and metastasis. In 2012, the company submitted an Investigational New Drug (IND) application to the FDA for Supinoxin. The company initiated a Phase I clinical in 2013 to study Supinoxin’s safety and efficacy in patients with solid tumors. In addition to these drug candidates, the company has two clinical stage drug candidates for indications other than cancer: Serdaxin, for major depressive disorder; and Zoraxel, for sexual dysfunction. The company also has three drug candidates in pre-clinical development: Archexin-Nano, RX-0047-Nano, and RX-21101. Strategy The company’s strategy has the following components: develop therapeutics with the potential to be first-in-class or market leaders; clinically develop drug candidates as orphan drugs; target signal transduction molecules with multiple drug candidates; establish partnerships with large pharmaceutical companies; review opportunities to in-license and advance compounds in oncology that have value creating potential and would strengthen its clinical development pipeline; and capitalize on the company’s management team’s expertise for drug development. Intellectual Property The company holds U.S. and foreign patents for its drug candidates that expire from 2020 to 2030. The company holds U.S. patents for Archexin, RX-3117, Supinoxin and RX-0047. The company also holds multiple foreign patents for Archexin, RX-3117, Supinoxin and RX-0047. Additional U.S. and foreign patent applications related to Archexin, RX-3117, Supinoxin, RX-0047 and RX-21101 are pending. In 2005, the company in-licensed the intellectual property rights to Zoraxel and Serdaxin from Revaax Pharmaceuticals, LLC (Revaax). Under the agreement with Revaax, the company obtained exclusive rights to four U.S. and other foreign patents related to Serdaxin and to two U.S. patents related to Zoraxel. The company also has rights to additional pending U.S. and foreign patent applications related to Zoraxel and Serdaxin. In 2013, the company was granted multiple U.S. and foreign patents. The U.S. patents granted include a patent for a series of novel anti-tumor quinazoline compounds, and a method patent for treatment of solid cancers for Supinoxin. The company’s foreign patents granted include a pharmaceutical composition and method patent of isoquinolinamine compounds, and a patent for the use of Archexin in Europe.
rexahn pharmaceuticals inc
15245 Shady Grove Road
Rockville, MD 20850
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