Rexahn's Lead Drug RX-3117 Beats Lilly's Gemzar In One-To-One Face Off Print E-mail
By Sharon di Stefano   
Monday, 12 January 2015 19:19

When peer-reviewed scientific articles publish, especially for investigational medicine, doctors and investors take notice. Few other accolades are held in such high esteem.

In December, Rexahn Pharmaceuticals (NYSEMKT:RNN) presented data in internationally acclaimed journal Anticancer Research where its RX-3117, through genetic manipulation, showed the ability to stop tumor growth with therapeutic potential where a well-known and commonly-used chemotherapy agent failed patients up to 40% of the time. Even more striking, RX-3117 can be given orally, competitively surpassing other drug companies that still resort to painful and lengthy intravenous injections to alleviate cancer's affliction.


The culmination of intensive research, Rexahn created an equivalent of cytidine, a biological component of our body's RNA that directs cells to attack tumors. Working with well-known researchers in Israel - Teva Pharmaceuticals Industries LTD (NYSE:TEVA), and the Department of Medical Oncology in Amsterdam, the company released new data to the scientific world showing its RX-3117 to not only stop malignancies in a number of solid tumor cancers, but also to beat a much-used but faulted chemotherapy, gemcitabine, known by its trade name Gemzar, an Eli Lilly & Co. (NYSE:LLY) offering for cancers of the lung, pancreas, bladder and breast, that has since gone generic.

Data is impressive: taking mice that had been pre-conditioned to grow tumors from human cancer cells, Rexahn's lead product RX-3117 was applied to nine cancerous conditions including colon, lung, pancreas, kidney and cervix. Gemcitabine failed to inhibit tumor growth, from a statistically significant zero to 30%. RX-3117 halted tumor growth from 62% to an astounding 100%. Clear from the study, on a one-to-one comparison, Rexahn's drug has so far proven superior, and animals did not suffer a loss of body weight, suggesting low toxicity.

I had a recent call with Rexahn's CEO, Peter Suzdak, Ph.D., where we discussed the scarcity of oral cancer drugs on the market. My own research revealed a number of misfires: Boniva, created jointly by GlaxoSmithKline plc (NYSE:GSK) and Roche Holding AG (OTCQX:RHHBY), an osteoporosis compound once tested for breast cancer with negative results; Afinitor by Novartis AG (NYSE:NVS) for cancer of the kidneys, breast, brain and pancreas that carries a risk of fatal renal yet a growth driver in the company's most recent fiscal yearcontributing to a portion of the $4.8 billion attributed to its pharmaceutical segment;and Sutent for renal cell carcinoma made by Pfizer, Inc. (NYSE:PFE), once a high-flier that has shown liver damage in clinical trials and post-marketing studies and expected to be surpassed by Votrient, another oral by GlaxoSmithKline for the same indication, but with the same set of risks. Oral cancer drugs have a long way to go before optimal treatment is achieved.


Both Dr. Suzdak and I agreed that Celgene Corp.'s (NASDAQ:CELG) Revlimid, a pill based on a derivative of birth defect-inducing thalidomide that began clinical trials as a treatment for AIDS wasting and now a multi-billion dollar blockbuster, has been the most successful of the oral anti-cancer drugs, though used mostly in blood cancer and not a direct threat to any potential Rexahn franchise.

In our conversation, Dr. Suzdak agreed that 'cocktails' using experimental drugs alongside standard chemotherapy is the way of future medicine, and that RX-3117, in addition to other compounds his company has under investigation, could very well lead the charge toward targeted cancer therapy because of higher efficacy with reduced side effects.

Gemzar treatment in pancreatic cancer has a resistant rate of up to 40%, a disappointing and frustrating scenario for oncologists and patients, for which Dr. Suzdak concurs. Researchers worldwide continue to study the mechanism by which Gemzar fails, as it is one of the few treatment options left in a disease with a survival rate of 1% within five years. I believe Rexahn's work with Gemzar, a darling of oncologists since its premier in 1996 until resistance was encountered, may prove better outcomes, reviving this compound as cancer practitioners' drug of choice for certain solid tumors and possibly propelling RX-3117 into huge worldwide markets as a partner medication.


Lilly had attempted to make Gemzar oral, with no good result. From a study done six years ago, 30 patients were given the tablet version and, in addition to low therapeutic effect, showed gastrointestinal toxicity with one patient death occurring from kidney failure. Gemzar used alone or in combination with other harmful anti-cancer agents had been the subject of an FDA warning letter for its association with adverse consequences. A new solution is needed for sufferers of one of the world's most dangerous diseases, and Rexahn has a hopeful answer.

Certain risks to an investment in Rexahn are as follow: it is small-capitalized, pre-revenue, early clinical trial results may not pan out in larger ones, and there may be the need to raise money. Regulator roadblocks may present anytime during the path toward approval. However, more than $35 million (as of the September quarter) sits in the company's coffers and burn rate is a frugal $3 million per quarter, a sign of good money management. Another risk to consider is recent data from an early and small study by Kurzrock, et al. at MD Anderson Cancer Center where efforts to overcome gemcitabine resistance displayed promising results when coupled with monoclonal antibody dasatinib, although only two of eight patients showed stability from disease at six months. More research like this, on a bigger scale and if positive, could lead to stiff competition for Rexahn.

Cancer is documented as the second leading cause of death worldwide, estimated to be a $225 billion industry by 2017. Part of the reason is lack of specificity of commonly-used chemotherapy agents, gemcitabine included. Targeted cancer therapy looks to be an answer as more researchers explore its significance. Rexahn is positioning itself in the vanguard of this mission, its new gemcitabine versus RX-3117 data accepted by researchers who continually hunt for answers to this disease while striving to provide a better quality of life.


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