Latest news on ZORAXEL!

[Flavio]

2010 may be a great year for Rexahn Pharmaceuticals Inc. According to the Washington Business Journal, the company that is developping ZORAXEL is about to sign a billion dollar deal with a big pharma company:


“If that happens, we will not have a need to raise any more money or go to the equity markets,” said Rexahn President Rick Soni. “And that’s a big plus.”


The Washington Business Journal article also mentions their plans to continue the tests of ZORAXEL in 2010:


"The biotech will also launch a new midstage test next year of its sexual dysfunction drug, Zoraxel, which regulates the body’s serotonin and dopamine neurotransmitters to uplift a man’s libido — in direct competition with Pfizer Inc.’s Viagra, Eli Lilly & Co.’s Cialis and Levitra, marketed by pharmas like GlaxoSmithKline PLC and Bayer AG."


ZORAXEL shows great promise and it will revolutionise the treatment of ED but they need the money to finance the tests, so this is great news.

Gentlemen, start buying some shares!

You can read the full story here:

Rexahn Pharmaceuticals on cusp of deal with big pharma company - Washington Business Journal:

[Flavio]

More news on Rexahn Pharmaceuticals and ZORAXEL:




"Rexahn Pharmaceuticals Provides Key Goals for 2010



Expects to advance and expand clinical development programs for Serdaxin®, Zoraxel™ and Archexin™ and initiate new clinical programs


ROCKVILLE, Md.--(BUSINESS WIRE)--Feb 17, 2010 - Rexahn Pharmaceuticals, Inc. (NYSE Amex: RNN), a clinical stage pharmaceutical company commercializing potential best in class oncology and CNS therapeutics, today provided guidance on its key pipeline, scientific and business goals for 2010.

“With our advancing clinical programs and robust pipeline of compounds for cancers and CNS-based disorders, such as Parkinson's, Alzheimer's, depression and sexual dysfunction, Rexahn is extremely well positioned to lead in the development of novel therapeutics for these disorders,” said Dr. Chang Ahn, CEO of Rexahn. “We look forward to continuing to expand our clinical programs and reporting data in 2010, bringing us closer to helping these patients in need.”

"These goals build on our successes in 2009, during which we announced positive clinical results for two of our lead clinical drug candidates, Serdaxin in Major Depressive Disorder (MDD) and Zoraxel for male sexual dysfunction, and we entered into a licensing and stock purchase agreement with an industry leader, Teva Pharmaceutical Industries, for the development of our novel anti-cancer compound, RX-3117,“ concluded Dr. Ahn.

“While 2009 was an important year for the validation of our pipeline drugs, we are even more excited about the next 12 to 18 months,” said Rick Soni, President and Chief Operating Officer of Rexahn. “Over this period, we expect to make significant clinical advances with our lead drugs, Serdaxin, Zoraxel and Archexin, and expand some of them into new indications. Further, we expect to add at least one clinical program in cancer and we will continue to seek out new partnerships across our clinical efforts, as there is significant interest among the bio-pharmaceutical industry in our intellectual property leadership."

Rexahn Goals for 2010:

Expand clinical development of Serdaxin to Parkinson's disease.

Advance Serdaxin in Phase IIb clinical study for depression.

Advance clinical development of Zoraxel for sexual dysfunction. In the first half of 2010, Rexahn expects to submit a protocol to the U.S. Food and Drug Administration (FDA) for a Zoraxel Phase IIb clinical study in sexual dysfunction. In May 2009 Rexahn announced data from a Phase IIa clinical study demonstrating Zoraxel's potential as an effective, new treatment of erectile dysfunction (ED) and as a safer alternative to currently marketed drugs for ED. The double blind, randomized, placebo-controlled, dose ranging study found that human subjects treated with Zoraxel demonstrated improved erectile function as measured by changes over the International Index of Erectile Function (IIEF) baseline score within the 8-week treatment period.

Continue clinical development of Archexin for the treatment of pancreatic cancer.

Initiate clinical program for RX-3117.

Form new partnerships."


Read more at: PharmaLive: Rexahn Pharmaceuticals Provides Key Goals for 2010

[Willie]

I did own some shares of Rexahn stock and made a few bucks off a recent spike

[Flavio]

More on Rexahn Pharmaceuticals and Zoraxel:

'Rexahn Pharmaceuticals, Inc. (Rexahn) is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of treatments for cancer, central nervous system (CNS) disorders, sexual dysfunction and other medical needs. The Company develops therapies that make it possible to regain normalcy for patients suffering from disease. It has three drug candidates in Phase II clinical trials during the year ended December 31, 2008, and six or more other drug candidates in pre-clinical development. The Company’s clinical-stage pipeline products include Archexin, an anti-cancer Akt inhibitor; Serdaxin, an antidepressant and CNS Disorders drug, and Zoraxel, an erectile dysfunction (ED) and sexual dysfunction drug. Rexahn’s pre-clinical pipeline includes RX-0201-Nano, RX-0047-Nano, Nano-polymer Anticancer Drugs, RX-0183, RX-5902 and RX-3117.

[...]

Zoraxel


Zoraxel is centrally acting in the CNS and may be a effective for patients who are responsive or unresponsive to PDE-5 inhibitors. Zoraxel is being developed as an orally administered, on-demand tablet to treat sexual dysfunction. Zoraxel is a dual enhancer of neurotransmitters in the brain that play a key role in sexual activity phases of motivation and arousal, erection and release. In preclinical animal studies, Zoraxel significantly improved sexual performance and suggested positive behavioral effects. Enrollment in the Zoraxel Phase IIa clinical trial for treatment of ED has been completed. The trial was a double blind, placebo-controlled, dose ranging study conducted at three United States study sites in up to 50 male subjects ages 18 to 65 with ED for six months. Main study endpoints for the eight-week treatment period were the sexual encounter profile (SEP) and the International index of erectile function (IIEF), both of which are validated surveys for assessing erectile function.'

Read more: http://connect-services.reuters.com/...ile?symbol=RNN

[Flavio]

And a different perspective on ZORAXEL and Rexahn (RNN):


'I am not saying buy this now, although the chart looks promising. Maybe you could buy on a pullback after doing your DD. People here know I don't like the little ones, since there is a lot more risk. However, if you play with a smaller amount of dollars you can sleep well at night.

There has been a bunch of news lately on RNN and I suppose when the fanfare subsides there could be a mass exodus, providing an entry opportunity for the stealthy. I don't suspect it will drop below 90 cents based on the current chart, though anything can happen.

The company seems to have some big potential drugs in the pipeline. The one I like most if the Zoraxel. This drug could save a lot of marriages and could change the world if it has the same effect in humans as in rats. Its reported that Zoraxel creates/enhances the desire to have sex. The spanish fly if you will. We are talking way bigger than Cialis, and Viagra as they don't increase desire to have sex. . So we are talking multi Billion dollar potential. The company has a current market cap of about 80 million at $1.22 a share.

Purportedly, they are also working on a drug for depression and alzheimers - with some success.

Do your own DD, and play only what you can afford to lose.

Cheers

OwlTrades'


Read more: RNN - A Speculative pick, worth taking a look at, by owltrades on P&P

[Flavio]

More praise of Zoraxel, this time by a prestigious urologist:


Commenting on Zoraxel's preliminary results, Dr. Myron Murdock, one of the study investigators and a nationally recognized urologist with expertise in the field of impotence and male-female sexual dysfunction, said, "ED is a condition that affects up to 30 million men in the United States. Based upon the Phase IIa preliminary results, Zoraxel clearly has the potential to be a safer and more effective alternative to currently marketed drugs for ED.”


Read more: Rexahn Reports Positive Preliminary Findings in Zoraxel Clinical Trial to Treat Erectile Dysfunction - Drugs.com MedNews

[Flavio]

ZORAXEL is all over the news. I got this on my e-mail today and I totally agree with what Dr. Ahn says about centrally acting drugs:


'Press Release

March 3, 2010

Rexahn Pharmaceuticals Submits Zoraxel Phase IIb Protocol to FDA
Company Forms Urology Scientific Advisory Board

ROCKVILLE, Md., Mar 03, 2010 (BUSINESS WIRE) -- Rexahn Pharmaceuticals, Inc. /quotes/comstock/14*!rnn/quotes/nls/rnn (RNN 1.21, +0.03, +2.53%) , a clinical stage pharmaceutical company commercializing potential best in class oncology and CNS therapeutics, today announced that it has submitted a Phase IIb protocol to the FDA for Zoraxel(TM)for the treatment of erectile dysfunction (ED).

"The progression of Zoraxel's clinical program is very encouraging," said Rexahn Chief Executive Officer, Dr. Chang Ahn. "We believe that the future of ED treatment lies in compounds that act on the central nervous system and effectively modify the condition, rather than targeting end organ erectile function. Zoraxel has the potential to be the first drug capable of this action and to establish a new standard of care for erectile dysfunction."

The Phase IIb study will continue to assess Zoraxel's efficacy in approximately 225 male subjects, ages 18 to 65, with ED. The double blind, randomized, placebo-controlled, 12-week study will include the Sexual Encounter Profile (SEP) survey, International Index of Erectile Function (IIEF) and quality of life study endpoints and will be conducted at multiple sites in the U.S. Data from the Phase IIa study completed in May 2009 reported that subjects treated with Zoraxel demonstrated improved erectile function and significant improvement in the quality of life measures. The study also found Zoraxel to be safe and well tolerated, with no serious adverse events reported.

Rexahn also announced the formation of a Urology Scientific Advisory Board (SAB). The SAB is composed of key opinion leaders in the field of urology who will advise Rexahn on the design and development of Zoraxel clinical trials. The members of the SAB include Arthur L. Burnett, M.D., M.B.A., F.A.C.S., Patrick C. Walsh Professor of Urology at The Johns Hopkins University; and Culley C. Carson III, M.D., F.A.C.S., Rhodes Distinguished Professor and Chief of Urology at University of North Carolina.'


Read more: Rexahn Pharmaceuticals Submits Zoraxel Phase IIb Protocol to FDA - MarketWatch

[therapy]

Flavio do you know when this magic pill will be out in the market?

[Flavio]

Originally Posted by therapy

Flavio do you know when this magic pill will be out in the market?

I contacted Rexahn recently and they told me that they expect to have ZORAXEL out in the market in 2013.