- Identify and form strategic partnerships. Rexahn continues to explore potential strategic partnerships to accelerate the development of its oncology pipeline. Rexahn’s pipeline of innovative oncology compounds features six potential best-in-class compounds – three clinical stage compounds (Archexin, RX-3117 (already partnered with Teva Pharmaceuticals), and RX-5902) and three pre-clinical compounds (RX-21101, RX-0047-N, and RX-0201-N). Each of these compounds offers an opportunity for a partner to bolster its oncology portfolio with differentiated assets possessing high potential clinical value.
- Continue RX-3117’s clinical development with Teva Pharmaceuticals. RX-3117 is a proprietary small molecule compound that inhibits DNA methyltransferase and DNA synthesis and is being co-developed with Teva Pharmaceuticals for the treatment of cancer. In August 2012, Rexahn and Teva concluded a first-in-human clinical study of RX-3117. In the clinical study RX-3117 met its primary objective of determining the drug’s oral bioavailability in humans. The study supports RX-3117’s position as a potential future alternative to market leading anti-metabolite therapies in the treatment of solid tumors in the colon, lung, bladder and pancreas. As a result of this clinical study, Teva increased its ownership in Rexahn to 6.3%. According to the Research and Exclusive License Option Agreement and the Securities Purchase Agreement between Rexahn and Teva, the total money received from Teva to date is $9.1 million. Rexahn expects to receive additional milestone payments from Teva in the second half of 2013 with the submission of an IND and patient enrollment in a phase I clinical trial.
- Initiate a Phase I clinical study with RX-5902. In 2013 Rexahn expects to initiate a Phase I first-in-human clinical trial of RX-5902, an orally available, first-in-class inhibitor of p68 RNA helicase for the treatment of various solid tumors, such as melanoma and cancers of the ovary, kidney and pancreas. Preclinical studies have demonstrated the inhibition of tumor growth and enhanced survival in in vivo animal xenograft models, synergistic action when combined with known anticancer agents, and potent anti-growth activity in drug-resistant cancer cells.
- Initiate a Phase II clinical trial with Archexin. Archexin is a proprietary first-in-class inhibitor of Akt protein kinase (Akt) which is localized in cancer cells. Following the positive top-line phase IIa clinical trial results for Archexin in pancreatic cancer reported in August 2012, Rexahn plans to move forward with its Phase II clinical program in 2013. Rexahn completed an open label study of Archexin in 2012 to determine the safety, tolerability and efficacy of the compound in combination with gemcitabine. The study demonstrated that this combination treatment provided a median survival of 9.1 months compared to the historical survival data of 5.65 months for standard single agent gemcitabine therapy.
Rexahn Pharmaceuticals Provides Key Goals For 2013
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