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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, today announced that the European Patent Office has granted the Company a patent, EP 1546180, for its clinical development candidate Archexin
® and its use for inhibiting the activated form of Akt-1 (phospho-Akt1)for the treatment of cancer.
Having successfully completed a Phase IIa clinical trial of Archexin in metastatic pancreatic cancer, Rexahn has conducted an extensive scientific, clinical and business analysis of other potential indications for additional Phase IIa clinical trials with the drug. Rexahn is now working with key clinical opinion leaders to finalize the design of a Phase IIa clinical trial in a selected tumor type and plans on updating investors on the tumor type selection and Phase IIa trial timeline in the fourth quarter of 2013.
Peter D. Suzdak, Ph.D., Rexahn’s Chief Executive Officer commented, “The issuance of this patent in Europe further strengthens our intellectual property estate on Archexin and provides IP protection and an enhanced position for Rexahn in a geography that represents a significant portion of the global oncology treatment market. This comes at a very important time for our Company, as we plan to embark on a new Phase IIa clinical trial for Archexin in the fourth quarter of this year.”
® is a unique anti-cancer drug candidate which inhibits the cancer cell specific signaling protein phospho-Akt1. Phospho-Akt1 is over expressed in human cancer cells as compared to normal healthy tissue, and is involved in cancer cell growth, survival, angiogenesis, and drug resistance. Phospho-Akt1 has been shown to be present in most human cancer cell lines including in breast, colon, kidney, liver, lung, ovarian, pancreatic, prostrate, and stomach cancer cell lines. Archexin has been shown to inhibit the growth of human cancer cell lines in tissue culture and well as increase survival in various mouse cancer xenograft models.
Archexin has completed a Phase I clinical trial in cancer patients with solid tumors and was shown to be safe and well tolerated. The dose-limiting toxicity was a grade 3 fatigue. In a small Phase IIa trial in advanced pancreatic cancer patients, Archexin in combination with gemcitabine was shown to be safe and well tolerated and demonstrated a preliminary efficacy signal with a median survival of 9.1 months in evaluable patients.