Rexahn's Akt-1 Inhibitor To Begin Phase II Trials For Kidney Treatment

Nov.25.13 | About: Rexahn Pharmaceuticals (RNN)

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Kidney cancer, known by its medical name renal cancer carcinoma (RCC), is a critical disease that leaves a meager 68% of sufferers alive after six months of diagnosis. Only a few pharmaceutical firms have tried to treat this prominent killer with little success using medications that cause more harm than good.

Bringing hope, Rexahn Pharmaceuticals (NYSEMKT:RNN) just announced that its lead drug Archexin will enter into Phase IIa trials for RCC, providing a sorely-needed alternative to the scant offerings of larger drug companies with proposed cures that center on stopping the growth of blood vessels to tumors, a worn out method that has not yielded strong results.

As a novel targeted therapy, Archexin uses the body's Akt-1 biochemical pathway to initiate cell death among tumors that might otherwise go unchecked. A true platform technology, Rexahn's compound formerly underwent Phase I trials in solid tumors with favorable safety data as an outcome. Later, Phase II trials in advanced pancreatic cancer, in which it was paired with the common chemotherapy drug gemcitabine, showed a median survival rate of 9.1 months versus 5.6 months with gemcitabine alone.

The decision to tackle one of the world's most insidious diseases was made after much deliberation with key leaders in the industry. Using clinical foresight, Rexahn had already obtained FDA Orphan Drug status for Archexin for RCC. Now, a Phase II trial is set to begin in December.

RCC, or kidney cancer, is found in adults and accounts for a high percentage of diagnosed tumors. Costs of currently available treatment are steep - Nexavar, one of the most popular drugs on the market sold by Bayer AG (OTCPK:BAYRY), is priced at $62,000 per year. Sutent, by Pfizer Inc. (NYSE:PFE), also well-prescribed, comes with a cost of $79,000. Avastin by Genentech, though an older drug, goes for $175,000 per year per patient. The alternative would be kidney transplant at $260,000 or more, depending on donor matching, with upwards of $20,000 per year to keep the patient's body from rejection.

Both Nexavar and Sutent are not pleasant to take. The former causes, in addition to diarrhea and fatigue, peeling of the skin on the palms of the hand and soles of the feet and adjustments in medication are common, adding to the patient's inconvenience and pain. Heart attack has occurred in an incidence up to almost 3%. Sutent's top list of side effects are more straightforward - death.

Yet global sales of Nexavar, considered a targeted cancer treatment, were more than $1 billion in 2011, the last available data. Since then, Bayer, however, has changed its mind and now touts the drug for thyroid cancer, leaving me to wonder whether this therapy has a home.

Another potential mistake for treating kidney cancer comes from the venerable GlaxoSmithKline plc (NYSE:GSK). Votrient is a hydrochloride salt masquerading as a biologic with "possible" halting of blood supply to tumors that in the meantime may cause life-threatening liver damage. Doctors foolish enough to prescribe this medicine are giving their patients the choice of which organ to surrender first - a kidney or the liver.

Because of the menace that it is, kidney cancer is getting attention, particularly from a diagnostic approach. A recent IPO from Cancer Genetics, Inc. (NASDAQ:CGIX), an investor heartbreak in the making, claims revenues rising 47% in the nine months ended September 30, 2013, but unfortunately does not clearly explain that almost half of those sales came from a clinical trial client, as evident from a careful reading of its most recent 10-Q. Cancer Genetics carries a valuation of approximately $143 million; Rexahn of $54 million, a sad disparity between two companies, one that genuinely strive for cancer cures and another that dabbles in also-ran probes to detect it. Regardless, should Cancer Genetics actually succeed in selling its product for kidney cancer, Rexahn could benefit by a potential increased detection.

Rexahn is moving forward with other clinical trials: orally administered Supinoxin for solid tumors is firmly in Phase I testing. RX-3117, aimed at tumor cell death, is set to enter Phase I next month also for solid tumors and has shown in preclinical studies a capacity to overcome chemotherapy drug resistance. Both compounds are being studied in varying doses to better facilitate the next phase of experimentation.

A direct offering of $5.3 million has been raised for Rexahn, completed last month, giving the company solid balance sheet footing to continue trials without worry. Operating expenses remain low, about $600,000 per month, due to sound management of costs.

Besides typical risks associated with investing in clinical stage biopharmaceutical companies like regulatory issues, timely study enrollment and the cost of research, Rexahn investigates a new technique that has been yet unproven in its efficacy. Early results do not necessarily culminate in Phase III success.

In sum, targeted cancer therapy, drugs that directly attack tumors, is a coveted area of oncology medicine and Rexahn has been proving itself to lead the chase. Renal cell carcinoma, a disease with little hope of effective treatment, is now a strong focus for this promising company where competition from bigger drug firms is falling flat.

Disclosure: I am long RNN. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article.