ROCKVILLE, Md.--(EON: Enhanced Online News)--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.”
Archexin® 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.
About Rexahn Pharmaceuticals, Inc.
Rexahn Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to developing best-in-class therapeutics for the treatment of cancer. Rexahn currently has three clinical stage oncology candidates, Archexin®, RX-3117, and SupinoxinTM (RX-5902) and a robust pipeline of preclinical compounds to treat multiple types of cancer. Rexahn has also developed proprietary drug discovery platform technologies in the areas of Nano-Polymer-Drug Conjugate Systems (NPDCS), nano-medicines, 3D-GOLD, and TIMES. For more information, please visit www.rexahn.com.
To the extent any statements made in this press release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about Rexahn’s plans, objectives, expectations and intentions with respect to future operations and products and other statements identified by words such as “will,” “potential,” “could,” “can,” “believe,” “intends,” “continue,” “plans,” “expects,” “anticipates,” “estimates,” “may,” other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause Rexahn’s actual results to be materially different than those expressed in or implied by Rexahn’s forward-looking statements. For Rexahn, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of Rexahn’s licensees or sublicensees; the success of clinical testing; and Rexahn’s need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect Rexahn’s actual results are described in Rexahn’s filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. Rexahn undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.