Ray Dirks Research

Rexahn to Give Celgene a Boost with New Combination Trial


New York, NY -- (SBWIRE) -- 11/13/2017 -- In a recent clinical landmark, Rexahn Pharmaceuticals dosed its first patient in a Phase II pancreatic cancer study using its unique oral biologic RX-3117 together with Celgene Corp.'s Abraxane. A combination of Abraxane and RX-3117, based on former solid data, can change the face of treating cancer, thanks to Rexahn's tumor targeting technology.

Earlier studies showed RX-3117 to be superior to Gemzar, made by Eli Lilly (NYSE:LLY) and used in pancreatic cancer. Gemzar, like Abraxane, is considered a standard of care for this lethal disease but Gemzar leads to resistance in patients at an unacceptable rate of 25% of the time, with only a paltry 5% response rate and four months of extended life. Gemzar, now generic, still generates around $200 million in annual sales, and Abraxane, as a branded drug, pulls in $970 million.

Doctors clearly need something new and better. Rexahn has the answer. If suboptimal drugs draw such high revenue, think how well RX-3117 will be received.

Here's the appeal of Rexahn's approach: RX-3117 with Abraxane will be studied in patients with no prior chemotherapy treatment. This is known as 'first-line' treatment and the dream of many big and small biotechs so their drugs can be used initially, enhancing sales. If RX-3117 works as first-line, and previous data point to this, Rexahn's clinical credibility is ensured. Once approved, oncologists will clamor for RX-3117 and sales, after approval, will soar.

Pancreatic cancer, though the 4th largest killer of all malignancies, is considered rare with roughly 53,700 cases in the US each year and 400,000 in the rest of the world.

What causes pancreatic cancer is puzzling. Possibly congenital factors; possibly exposure to harmful chemicals in the environment or tobacco smoke. Possibly random changes in genes. The pancreas is found deep inside the body and problems are hard to detect, so early tumors cannot be seen or felt through routine physical exams. When found, it's usually too late as the cancer has spread. Then and only then do patients show symptoms like severe abdominal pain. This is why mortality is high.

Through its network of medical and research talent, Rexahn enrolled patients for its Phase II study of RX-3117 coupled with Abraxane, all the better to get fast results and quicken the regulatory path. Now its first patient has been treated. More will follow.

The future: Rexahn, ever forward-thinking, sees RX-3117 also used with current cancer immunotherapy drugs, primarily popular PD-1 inhibitors like Merck & Co's Keytruda and Bristol-Myers Squibb's Opdivo.

In Rexahn's third quarter (ended September 30, 2017), cash and investments stood at almost $23 million, beefed up by a direct offering of shares to institutional investors for gross proceeds of $8 million. Exercise of stock warrants and options contributed to its war chest. Funds will greatly aid in moving RX-3117 through pancreatic cancer trials. With a burn rate of roughly $1.4 million per month (although variable quarter-to-quarter), close to a two-year runway is likely.

This is to point out that Rexahn has historically, and continues to use funds conservatively.

Rexahn moves forward, with an excellent chance of bringing a more refined and effective medicine than Gemzar or Abraxane for pancreatic cancer, and has proven to do so in clinical trials by destroying cancer cells at their source. More good news: a premier European drug regulator has recognized RX-3117's importance and issued a recommendation for Orphan Drug designation, just as the FDA did in 2014. Patents surrounding RX-3117 are protected until 2036.

RX-3117 could someday emerge as the treatment of choice by oncologists at the onset of pancreatic cancer diagnosis. If this current clinical trial with Abraxane is successful, as past ones were with Gemzar, toxic chemotherapy can be avoided. Upcoming trial read-outs, expected next year, could bring to Rexahn an accelerated FDA approval nod, and ultimately alter the landscape in treating metastatic pancreatic cancer.

RAY DIRKS Research suggests that Readers/Investors place no more than 1% of the funds they devote to common stocks in any one issue. It's best to diversify.

About Ray Dirks
Ray Dirks came to Wall Street with Goldman, Sachs & Co. in 1963 where he was established as the leading insurance stock analyst dealing with institutional investors and high -net worth investors both in the U.S. and internationally. In 1973 Ray uncovered the biggest Ponzi scheme of the 20th century, the Equity Funding fraud. Over the years Ray has expanded his stock market research to include Healthcare Stocks and Special Situations. Ray has written two books, "The Great Wall Street Scandal" and "Heads You Win, Tails You Win", published by McGraw-Hill and Bantam Books respectively. He continues to provide research to institutions and individuals, and he manages money for some individual investors.

For more information visit: http://www.raydirks.com.