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Rexahn Pharmaceuticals, Inc. (RNN) recently announced clinical data that I believe will bring it to the forefront of new orally bioavailable cancer treatments. The catalyst for this breakthrough is the publication of an article in a leading, peer-reviewed medical journal, Investigational New Drugs, devoted to reporting anti-cancer treatments in early stages of development.
RX-3117, the compound highlighted can, according to investigators, be administered as a pill, relieving cancer survivors of painful hours of intravenous chemotherapy that makes them nauseous and unable to eat, often with widespread mucous membrane lesions of the mouth and throat. The present batch of oral cancer drugs are suboptimal, and may be dangerous. Gleevec, a strange molecular hybrid of monoclonal antibody and toxic salt sold by Novartis AG (NVS), was designed to lower the number of white blood cells versus red, but instead can cause hemorrhaging. Xeloda, made by Genentech USA, Inc., is a compound that changes into a common chemotherapy agent once in the bloodstream, known for violent episodes of diarrhea and vomiting. The worst offender is Cytoxan by Bristol-Myers Squibb Co. (BMY), whose side effect profile includes life-threatening closure of the esophagus, due to its close resemblance to mustard gas used in World War II.
Because RX-3117 is a compound that works within the body's own biochemical pathways, its mechanism of action uses natural DNA synthesis to disrupt cancer's metabolism, and toxicity profiles are greatly reduced. Preclinical studies showed that RX-3117 shrinks tumors and in August 2012, a successful Phase I revealed that RX-3117 sufficiently entered the bloodstream to cause a therapeutic effect.
RX-3117 is effective in at least 50 cancer cell lines in humans, affording it broad potential. Although management has not yet revealed which cancer indication will be pursued in trials scheduled for later this year, the above-mentioned lines include lung, kidney, colon and pancreas, representing combined worldwide markets of over $30 billion. RX-3117 has also overcome resistance to certain chemotherapy drugs, enhancing its value as a companion treatment.
Not long ago, the license to RX-3117 was returned to Rexahn when its alliance with Teva Pharmaceutical Industries Limited (TEVA) unraveled after Teva's readjustment of its pipeline focus, as previously reported. This could eventually work in Rexahn's favor as new, better suited partners show interest.
RX-3117 should prove to be a valuable pipeline addition to Rexahn's key drug, Archexin, an Akt-1 inhibitor showing strong signs of cancer-fighting ability now solidly in Phase II trials for pancreatic disease, and the recipient of the FDA's prized Orphan Drug status for up to five different indications. Pancreatic cancer is a stubborn disease to treat; Amgen, Inc. (AMGN) was not successful, nor was Merck & Co. (MRK), leaving Rexahn in the lead.
Rexahn faces the same risks of any innovative biotech firm -- clinical and regulatory hurdles, capital funding requirements, and competition from larger, better-financed drug firms. The company has approximately $15.7 million in cash and uses operating funds conservatively. Earnings per share loss, reflective of its burn rate, widened only slightly in the three months ended June 30th, from ($0.01) to ($0.03).
This is a company with huge potential, trading at an undeserved market capitalization of $67.8 million, set to introduce new cancer compounds directed toward billion dollar industries, with one of its lead drugs based on oral administration where the safety of human biochemistry effectively removes a regulatory roadblock.