Rexahn Pharmaceuticals, Inc., a clinical stage biopharmaceutical company, engages 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, other candidates in preclinical development, and two drug candidates that are not being actively developed. Pipeline Drug Candidates The company’s three clinical stage drug candidates in active development are Archexin, RX-3117, and Supinoxin (RX-5902). Archexin Archexin is a potent inhibitor of the protein kinase Akt-1, 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 (the ‘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 RX-3117 is a small molecule nucleoside compound with an anti-metabolite mechanism of action, and it has therapeutic potential in a range of cancers, including colon, lung and pancreatic cancer. 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. RX-3117 has received orphan drug designation from the FDA for pancreatic cancer. Supinoxin (RX-5902) Supinoxin (RX-5902) is a potential small molecule that inhibits the phosphorylation of p68, a protein that plays a key role in cancer growth, progression and metastasis. In 2012, the company submitted an Investigational New Drug 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. The company also has two drug candidates in pre-clinical development, such as Archexin-Nano, which might provide clinical benefits, including targeted higher cellular intake, extended circulation time, reduced drug toxicity, and improved efficacy; and RX-21101, an (N-(2-Hydroxypropyl) methacrylamide)-docetaxel-folate, which might bolster efficacy against tumors while lowering toxicity by specific tumor targeting and increased stability in the body. In addition to these drug candidates, the company has two clinical stage drug candidates for indications other than cancer, such as Serdaxin, for major depressive disorder; and Zoraxel, for sexual dysfunction. In addition to the company’s drug development, it is working on proprietary research technologies, including the company’s multi-target aimed ligands platform and nano-based drug delivery systems. Its ligand discovery platform, The Inhibitors of Multi-Expression Signals, permits the company to identify potentially important targets that control multiple genes or signaling events in cancer cells. The company’s 3-D Gateway of Ligand Discovery integrates three-dimensional molecular modeling with databases of chemicals and proteins and ligand filtering and generation, which help the company discover novel lead compounds. The company’s nano-based drug delivery systems, such as those used in the multiple nanoliposomal- and nanopolymer-based anticancer drugs that the company is testing, might increase the availability of a drug at the disease site, minimize adverse reactions, and provide longer duration of action. Strategy The company’s strategy is to continue building a significant product pipeline of innovative drug candidates that the company would commercialize alone or with partners. This strategy has various key components, such as developing innovative therapeutics with the potential to be first-in-class or market leaders; clinically developing drug candi
rexahn pharmaceuticals inc
15245 Shady Grove Road
Rockville, MD 20850
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