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Company Description

Contact Info

15245 Shady Grove Road

Suite 455

Rockville, MD 20850

United States

Phone: 240-268-5300

Fax: 240-268-5310

Rexahn Pharmaceuticals, Inc., a development stage biopharmaceutical company, focuses on the development of treatments for cancer to patients worldwide. The company’s primary research and development focuses on therapeutic for treating cancer. The company’s pipeline features one drug candidate in Phase II clinical trials, two oncology candidates which may begin Phase I trails, and other drug candidates in pre-clinical development. In addition, the company has two central nervous system (CNS) candidates, Serdaxin and Zoraxel, that are in Phase II clinical development and the company is exploring various options to fund the further development of these two compounds. The company has three clinical stage oncology candidates. The first candidate, Archexin, is an inhibitor of the protein kinase Akt-1. Archexin received ‘orphan drug’ designation from the U.S. Food and Drug Administration (FDA) for five cancer indications (renal cell carcinoma (RCC), glioblastoma, ovarian cancer, stomach cancer and pancreatic cancer). Archexin has completed a Phase IIa clinical trial for the treatment of pancreatic cancer. Another clinical stage candidate is RX-3117, which is a small molecule, new chemical entity nucleoside compound that has an anti-metabolite mechanism of action, and has therapeutic potential in a range of cancers, including colon, lung, and pancreatic cancer. RX-3117 completed an exploratory Phase I clinical study in 2012 that demonstrated the oral bioavailability of RX-3117 in humans with no adverse effects reported in the study. The company has a partnership with Teva Pharmaceuticals Industries, Limited (Teva) for the development of RX-3117. RX-5902 is another clinical stage oncology candidate that is a first-in-class small molecule that inhibits the phosphorylation of p68 RNA helicase, a protein that plays a key role in cancer growth, progression, and metastasis. In July, 2012 Rexahn submitted an Investigational New Drug (IND) Application to the FDA for RX-5902. In 2012, the company was issued a United States patent (No. 8,314,100), titled ‘1-[6,7-substituted alkoxyquinoxalinyl) aminocarbonyl]-4-(hetero) arylpiperazine derivatives,’ which covers its quinoxalinyl-piperazine compounds, the process for the preparation of such compounds and their pharmaceutical composition. The patent includes RX-5902. Serdaxin is a developmental stage drug candidate for major depressive disorder (MDD). The company completed a 300 patient Phase IIb clinical trial of Serdaxin in MDD in 2011. Zoraxel is a developmental stage drug for sexual dysfunction that directly modulates the sexual activity control center in the brain. The Phase IIa study was completed in May 2009 with positive results for patients for erectile dysfunction (ED). Zoraxel is an immediate release formulation of clavulanic acid, the same active ingredient found in Serdaxin. The company is looking for partners who would fund the clinical development of Zoraxel. Pre-clinical Pipeline The company’s pre-clinical pipeline includes the following: RX-0201-Nano, Nanoliposomal anticancer Akt inhibitor: RX-0201, the active ingredient of Archexin, is a first-in-class, potent inhibitor of the Akt protein kinase. RX-0201-Nano is a nanoliposomal product of RX-0201 with high incorporation efficiency and good stability. RX-0047-Nano, Nanoliposomal anticancer HIF-1á inhibitor: RX-0047 is a potent inhibitor of HIF-1á, a key transcription factor involved in cancer cell survival, metastasis, and angiogenesis. RX-0047-Nano is a nanoliposomal product of RX-0047 with high incorporation and good stability. RX-21101, Nano-polymer Anticancer Drug: RX-21101(HPMA-docetaxel) is an anticancer drug that can overcome the downside of cytotoxic compounds, such as poor solubility, stability, and severe adverse reactions. Strategy The company’s strategy is to continue building a significant product pipeline of innovative medicines that the company would commercialize alone or with pharmaceutical partners. The company’s strategy includes the following components: develop therapeutics with the potential to be first-in-class or market leaders; target signal transduction molecules

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