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Proactiveinvestors United Kingdom Rexahn Pharmaceuticals http://www.proactiveinvestors.co.uk Proactiveinvestors United Kingdom Rexahn Pharmaceuticals RSS feed en Wed, 23 May 2012 23:54:28 +0100 http://blogs.law.harvard.edu/tech/rss Genera CMS action@proactiveinvestors.com (Proactiveinvestors) action@proactiveinvestors.com (Proactiveinvestors) <![CDATA[Rexahn Pharmaceuticals' CEO to become CSO; new CEO expected by September ]]> http://www.proactiveinvestors.co.uk/companies/news/26162/rexahn-pharmaceuticals-ceo-to-become-cso-new-ceo-expected-by-september-26162.html Drug developer Rexahn Pharmaceuticals (NYSE Amex: RNN) said Monday that current CEO Dr. Chang Ahn has decided to become chief scientific officer of the company and relinquish his role as chief executive.

Dr. Ahn will, however, continue as chairman of Rexahn's board of directors. The company has already begun the search for a new CEO to succeed Dr. Ahn, with an appointment expected by the end of September this year. In the meantime, Dr. Ahn will serve as both CEO and CSO.
 
"Leading Rexahn as its CEO has been a tremendously exciting and gratifying experience, but as Rexahn continues its rapid development and transformation to a commercial biopharmaceutical enterprise, I feel now is the right time for a new CEO to take the reins and bring our Company to the next level," said Dr. Ahn.

]]> Tue, 08 Mar 2011 08:58:00 +0000 http://www.proactiveinvestors.co.uk/companies/news/26162/rexahn-pharmaceuticals-ceo-to-become-cso-new-ceo-expected-by-september-26162.html <![CDATA[Rexahn Pharmaceuticals issued Japanese patent for anti-cancer compound RX-0047 ]]> http://www.proactiveinvestors.co.uk/companies/news/24178/rexahn-pharmaceuticals-issued-japanese-patent-for-anti-cancer-compound-rx-0047-24178.html Rexahn Pharmaceuticals (NYSE Amex: RNN) said Monday it was awarded a Japanese patent related to its preclinical compound RX-0047 used for cancer treatment.

The patent, titled, "Antisense Oligonucleotides that Inhibit Expression of HIF-1," covers a method of inhibiting HIF-1 in human cells or tissues. HIF-1, a human protein, is involved in angiogenesis, cancer cell survival, radiation resistance and cancer spread, and as a result, increased levels are associated with poor prognosis and increased mortality.

According to Rexahn, RX-0047 has shown that it can inhibit the expression of HIF-1 and also induce toxicity in several cancer cell lines.

"Obtaining this additional patent coverage for RX-0047 in the large pharmaceutical market of Japan is another step forward for the development of this compound, and helps strengthen our overall global intellectual property position," said president Rick Soni.

Corresponding patents have already been issued to Rexahn in other jurisdictions, including the U.S. and Europe.

Rexahn is developing therapies for cancer, CNS disorders, sexual dysfunction and other unmet medical needs. The company currently has three drug candidates in Phase II clinical trials: Archexin, Serdaxin, and Zoraxel.

]]> Tue, 21 Dec 2010 10:30:00 +0000 http://www.proactiveinvestors.co.uk/companies/news/24178/rexahn-pharmaceuticals-issued-japanese-patent-for-anti-cancer-compound-rx-0047-24178.html <![CDATA[Rexahn Pharmaceuticals Presents Serdaxin Phase IIa Clinical Data at the American College of Neuropsychopharmacologists ]]> http://www.proactiveinvestors.co.uk/companies/news/23846/rexahn-pharmaceuticals-presents-serdaxin-phase-iia-clinical-data-at-the-american-college-of-neuropsychopharmacologists--23846.html Rexahn Pharmaceuticals (NYSE AMEX:RNN), a clinical stage pharmaceutical company based in Rockville, Maryland, announced today that clinical data on the antidepressant activity of its Serdaxin drug were presented yesterday at the American College of Neuropsychopharmacologists Annual Meeting, held in Miami Beach, Florida.

The data, which comes from Serdaxin’s Phase IIa study, was presented by Joshua Rosenthal, one of the co-authors of the study.

The study’s results, which were first announced back in April by Rexahn, showed that patients with severe major depressive disorder taking 5 mg of Serdaxin had statistically significant improvement in Montgomery-Asberg Depression Rating Scale scores after 8 weeks of treatment, compared to a placebo. 

"Serdaxin represents a new mechanism and approach to anti-depression therapy by enhancing both the serotonin and dopamine activity of neural transmitters. We believe this approach has the potential to help a broader spectrum of patients than the currently marketed therapeutics," said Rick Soni, the Chief Operating Officer of Rexahn.

According to the company, Serdaxin has also shown neuroprotective potential in animals treated with neurotoxins, and may have important applications in the treatment of human neurodegenerative disorders such as Parkinson's disease and Alzheimer disease. Animal model studies also suggest that Serdaxin reduces aggressive behavior and relieves anxiety, Rexahn said.

The company said it plans to initiate a larger phase IIb clinical trial, involving about 300 patients, in the second half of 2010.

]]> Thu, 09 Dec 2010 12:25:00 +0000 http://www.proactiveinvestors.co.uk/companies/news/23846/rexahn-pharmaceuticals-presents-serdaxin-phase-iia-clinical-data-at-the-american-college-of-neuropsychopharmacologists--23846.html <![CDATA[Rexahn Pharmaceuticals adds US patent to CNS treatment portfolio ]]> http://www.proactiveinvestors.co.uk/companies/news/23259/rexahn-pharmaceuticals-adds-us-patent-to-cns-treatment-portfolio-23259.html Rexahn Pharmaceuticals (NYSE Amex: RNN) said Monday that the company was issued an additional U.S. patent for its central nervous system treatment portfolio.

The patent, entitled "Oral Neurotherapeutic Cephalosporin Sulfoxide and Sulfone-containing Compositions”, covers neurotherapeutic pharmaceutical formulations for cefazoline sulfone, cefazoline sulfoxide, ceftriaxone sulfoxide, and ceftriaxone sulfone for treating neurological disease and behavioral and cognitive disorders.

"New patent coverage for these cefazolin and ceftriaxone groups broadens our CNS-related portfolio and strengthens our intellectual property position as well,” said president Rick Soni. 

Rexahn currently has three drug candidates in Phase II clinical trials -- Archexin, Serdaxin, and Zoraxel – and a pipeline of preclinical compounds to treat multiple cancers and CNS disorders.

]]> Mon, 22 Nov 2010 18:53:00 +0000 http://www.proactiveinvestors.co.uk/companies/news/23259/rexahn-pharmaceuticals-adds-us-patent-to-cns-treatment-portfolio-23259.html <![CDATA[Rexahn Pharmaceuticals publishes anti-cancer compounds study in medical journal ]]> http://www.proactiveinvestors.co.uk/companies/news/22842/rexahn-pharmaceuticals-publishes-anti-cancer-compounds-study-in-medical-journal-22842.html Rexahn Pharmaceuticals (NYSE Amex: RNN) said Monday it published a study demonstrating the potent anticancer activity of its quinoxalinyl-piperazine drug compounds in a medical journal.

The study, published in the Bioorganic & Medicinal Chemistry, showed that the compounds "strongly inhibit" the growth of human cancer cells through programmed cell death, including colorectal cancer cells that were resistant to other cancer treatments.

The company said that quinoxalinyl-piperazine also has a synergistic toxic effect on cells when combined with several known cancer drugs such as paclitaxel, doxorubicin, cisplatin, gemcitabine or 5-fluorouracil.

During the trial, it was proven that with drug resistant HCT-15 cancer cells, the company's compounds had a stronger anti-cancer effect than paclitaxel, decreasing cancer growth by 70-fold, the company said.

"This result implies that the compound may control and overcome drug resistance," Rexahn concluded in a statement.

Rexahn currently has three drug candidates in phase II clinical trials, including Archexin, Serdaxin, and Zoraxel, and a pipeline of preclinical compounds to treat multiple cancers and CNS disorders.

]]> Tue, 09 Nov 2010 09:24:00 +0000 http://www.proactiveinvestors.co.uk/companies/news/22842/rexahn-pharmaceuticals-publishes-anti-cancer-compounds-study-in-medical-journal-22842.html <![CDATA[Rexahn Pharmaceuticals receives more than $800,000 in US govt grants for projects ]]> http://www.proactiveinvestors.co.uk/companies/news/22750/rexahn-pharmaceuticals-receives-more-than-800000-in-us-govt-grants-for-projects-22750.html Rexahn Pharmaceuticals (NYSE Amex:RNN) said Thursday it has been awarded US government grants totaling more than $822,000 for the company's drug projects.

The grants were awarded as part of a program under the Patient Protection and Affordable Care Act of 2010, designed to provide tax credits or grants to biotechnology companies with no more than 250 employees for expenses related to a medical development project.

"We are very pleased to receive the grants for all four applications we submitted. The award will further strengthen Rexahn's financial position as we advance our drug development projects for cancers, depression, and erectile dysfunction," said president and COO Rick Soni.

The program targeted projects that showed potential to produce new therapies to treat areas of unmet medical need or chronic or acute diseases, as well as reduce long-term health care costs in the United States.

The grants are meant to reimburse up to 50% of investments in qualifying projects in 2009 and 2010.

Rexahn currently has three drug candidates in phase II clinical trials: Archexin for pancreatic cancer, Serdaxin for depression, and Zoraxel for erectile dysfunction. The company is also developing a drug delivery system for cancer, which works to target cancer cells to avoid damage to healthy tissue.

]]> Fri, 05 Nov 2010 11:13:00 +0000 http://www.proactiveinvestors.co.uk/companies/news/22750/rexahn-pharmaceuticals-receives-more-than-800000-in-us-govt-grants-for-projects-22750.html <![CDATA[Rexahn Pharmaceuticals rallies on publication of new preclinical data for anti-cancer compounds ]]> http://www.proactiveinvestors.co.uk/companies/news/22237/rexahn-pharmaceuticals-rallies-on-publication-of-new-preclinical-data-for-anti-cancer-compounds--22237.html Rexahn Pharmaceuticals (NYSE Amex: RNN) said Tuesday that it published new preclinical data on the development of anti-cancer compounds in the European Journal & Medicinal Chemistry.

In the published study, Rexahn said that various substituted 3-aryl-1-isoquinolinamine derivatives were shown to have "excellent" toxicity against eight different human cancer cells, including breast, prostate, colon, ovary, kidney, pancreas, glioblastoma and melanoma.

"In this second published study, we further establish that isoquinolinamine derivatives, such as our anti-cancer compound RX-8243 - a new chemical entity - are potent anti-cancer compounds that have the potential to be developed into chemotherapeutic agents," said president Rick Soni.

Last month, Rexahn announced the publication of new preclinical data in Bioorganic & Medicinal Chemistry Letters demonstrating that RX-8243, an isoquinolinamine analogue, significantly inhibits the growth of human cancer cells, including paclitaxel-resistant human colorectal cancer cells.

Rexahn develops and commercialized drugs for cancer, CNS disorders and sexual dysfunction. The company currently has three drug candidates in phase II clinical trials:  Archexin, Serdaxin, and Zoraxel - and a pipeline of preclinical compounds to treat different cancers and CNS disorders.

The company was up more than 3% in the first hour of trading on Tuesday at $1.2 as of 9:41am ET.

]]> Tue, 19 Oct 2010 15:14:00 +0100 http://www.proactiveinvestors.co.uk/companies/news/22237/rexahn-pharmaceuticals-rallies-on-publication-of-new-preclinical-data-for-anti-cancer-compounds--22237.html <![CDATA[ Rexahn says study shows neuroprotective effects of clavulanic acid, main ingredient in Seradaxin drug ]]> http://www.proactiveinvestors.co.uk/companies/news/21260/-rexahn-says-study-shows-neuroprotective-effects-of-clavulanic-acid-main-ingredient-in-seradaxin-drug-21260.html Clinical stage pharma company Rexahn Pharmaceuticals (NYSE Amex: RNN) said Tuesday that a published Drug Development Research article indicates that clavulanic acid, the active ingredient of the company's lead central nervous system drug Seradaxin, protects neurons from brain damage associated with neurodegnerative disease.

In the study, rodents that were exposed to different neurotoxins, were administered with clavulanic acid, which protected neurons in the hippocampus and dopaminergic regions of the brain that are critical in Alzheimer's and Parkinson's disease, respectively.

"The exciting neuronal protective properties of clavulanic acid make it a highly promising treatment for neuronal cell death diseases like Parkinson's and Alzheimer's," said Rexahn CEO Chang Ahn.

Parkinson's disease afflicts five million people worldwide, and with the aging of the baby boom generation, that population is expected to double by 2030.

According to the Alzheimer's Association, by 2050, the number of Americans aged 65 and older with Alzheimer's is projected to reach between 11 million and 16 million, unless medical breakthroughs can prevent or more effectively treat the disease.

Currently, Alzheimer's and Parkinson's therapies only provide symptomatic relief.

"Clavulanic acid has breakthrough potential of shielding the brain cell survival mechanisms, rather than fighting one-by-one the multitude of triggers that can activate the cell death mechanisms common in Alzheimer's and Parkinson's," added Ahn.

Alzheimer's has at least five major triggers, while Parkinson's has three major dysfunctioning mechanisms. Rather than intercepting and fighting each trigger, clavulanic acid has shown to broadly protect brain cell mechanisms.

Rexahn develops and commercializes therapeutics for cancer, CNS disorders, sexual dysfunction and other unmet medical needs. The company currently has three drug candidates in Phase II clinical trials, including Archexin, Serdaxin, and Zoraxel.

The company rallied more than 3% Tuesday morning, to trade at $1.24 on NYSE Amex Exchange.

]]> Wed, 22 Sep 2010 08:34:00 +0100 http://www.proactiveinvestors.co.uk/companies/news/21260/-rexahn-says-study-shows-neuroprotective-effects-of-clavulanic-acid-main-ingredient-in-seradaxin-drug-21260.html <![CDATA[Rexahn Pharma hires investment banker Frederick Frank as an independent consultant ]]> http://www.proactiveinvestors.co.uk/companies/news/17430/rexahn-pharma-hires-investment-banker-frederick-frank-as-an-independent-consultant-17430.html Rexahn Pharmaceuticals Inc (AMEX:RNN) said it hired Frederick Frank, the current vice-chairman of Peter J. Solomon Co (PJSC), to advise on a range of corporate activities. As an independent consultant, Frank is expected to help Rexahn build its assets and drive shareholder value.

"Rexahn is in a great position with a strong pipeline, best-in-class products, and the positive Phase II clinical results of Serdaxin and Zoraxel. I am looking forward to helping the company build value for these assets," Frederick Frank said.

The company highlighted Frank’s extensive experience in investment banking, noted his specific experience in relation to the pharmaceutical, biotechnology, healthcare services, medical device and nutraceutical industries. “He has been involved in hundreds of financings, strategic alliances and merger and acquisition transactions in the global healthcare industry”, Rexahn stated.

Rexahn chairman and CEO Dr. Chang Ahn commented: “His expertise in global healthcare and 50 years of banking experience focused in biotechnology will be a great asset to the company.”

Rexahn is a clinical stage biopharmaceutical company, commercializing oncology and central nervous system (CNS) therapeutics. Rexahn’s core scientific expertise is in signal transduction; this has produced a drug portfolio with significant potential clinical value.

The company is working on a variety of therapeutics for cancer, CNS disorders, sexual dysfunction and other unmet medical needs.

Rexahn currently has three drug candidates in Phase II clinical trials, Archexin, Serdaxin, and Zoraxel - all potential best in class therapeutics - and a pipeline of preclinical compounds in development to treat multiple cancers and CNS disorders. Rexahn also operates key R&D programs of nano-medicines, 3D-GOLD, and TIMES drug discovery platforms.

One of the company's most advanced development products is Serdaxin, which according to Rexahn prevents neuronal death which is a disease mechanism implicated in many brain disorders from depression to Parkinson’s and Alzheimer’s diseases. The treatment protects dopamine-releasing neurons from environmental damage. Serdaxin directly targets the disease mechanism by slowing or halting the progression of the disease, Rexahn state.

The company has multiple clinical programs planned for investigating Serdaxin in the treatment of anxiety disorders, Parkinson’s disease, Alzheimer’s disease and neurodegenerative illnesses, neuro-protection and bio-defense uses.

]]> Tue, 08 Jun 2010 09:39:00 +0100 http://www.proactiveinvestors.co.uk/companies/news/17430/rexahn-pharma-hires-investment-banker-frederick-frank-as-an-independent-consultant-17430.html <![CDATA[Rexahn Pharma to Initiate Zoraxel Phase IIb trial for treating erectile dysfunction ]]> http://www.proactiveinvestors.co.uk/companies/news/16558/rexahn-pharma-to-initiate-zoraxel-phase-iib-trial-for-treating-erectile-dysfunction--16558.html Rexahn Pharmaceuticals Inc (AMEX: RNN), a clinical stage pharmaceutical company commercializing potential best in class oncology and central nervous system (CNS) therapeutics, said it will initiate a Phase IIb clinical trial for Zoraxel in the treatment of erectile dysfunction (ED).

The Phase IIb study is designed 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 International Index of Erectile Function (IIEF), Sexual Encounter Profile (SEP) survey, and quality of life study endpoints.

The Phase IIb study is expected to begin in the second half of 2010 and the preliminary data is expected to be available in 2011. The study will be conducted at multiple sites in the US.

Rexahn’s decision to move forward with the Phase IIb trial is supported by data from a Phase IIa proof of concept study of 39 ED patients treated with Zoraxel.

The Phase IIa study was completed in May 2009 and demonstrated that Zoraxel consistently improved IIEF scores of treated subjects. Furthermore, the study found that treated subjects demonstrated a dose dependent treatment effect with improved erectile function and quality of life measures. Zoraxel was also found to be safe and well tolerated, with no serious adverse events reported.

Rexahn currently has three drug candidates in Phase II clinical trials, Archexin, Serdaxin, and Zoraxel - all potential best in class therapeutics - and a pipeline of preclinical compounds in development to treat multiple cancers and CNS disorders. Rexahn also operates key R&D programs of nano-medicines, 3D-GOLD, and TIMES drug discovery platforms.

Zoraxel is being developed as an orally administered tablet for on-demand use, and is one of three clinical stage compounds being developed by Rexahn. Zoraxel has a well established and excellent safety record in humans and studies demonstrate a lack of severe side effects associated with current standard of care phosphodiesterase (PDE-5) inhibitor ED drugs. Zoraxel is a centrally acting, dual enhancer of serotonin and dopamine in the brain, whereas PDE-5 inhibitors work in peripheral blood vessels.

]]> Thu, 13 May 2010 10:52:00 +0100 http://www.proactiveinvestors.co.uk/companies/news/16558/rexahn-pharma-to-initiate-zoraxel-phase-iib-trial-for-treating-erectile-dysfunction--16558.html <![CDATA[Rick Soni of Rexahn Pharmaceuticals talks about Serdaxin as an anti-depressant, a partnership with Teva Pharmaceuticals and Phase 2 trials. ]]> http://www.proactiveinvestors.co.uk/companies/news/15996/rick-soni-of-rexahn-pharmaceuticals-talks-about-serdaxin-as-an-anti-depressant-a-partnership-with-teva-pharmaceuticals-and-phase-2-trials--15996.html Rick Soni, President and COO of Rexahn Pharmaceuticals, talks about a strong positive signal that Serdaxin can work as an anti-depressant, a planned Phase 2b trial for this application, a partnership with Teva Pharmaceuticals, Zoraxel as a possible treatment for erectile dysfunction, and Archexin’s Phase 2 trials for pancreatic cancer.

]]> Tue, 27 Apr 2010 11:18:00 +0100 http://www.proactiveinvestors.co.uk/companies/news/15996/rick-soni-of-rexahn-pharmaceuticals-talks-about-serdaxin-as-an-anti-depressant-a-partnership-with-teva-pharmaceuticals-and-phase-2-trials--15996.html <![CDATA[Rick Soni, President and COO of Rexahn Pharmaceuticals, talks to Proactiveinvestors ]]> http://www.proactiveinvestors.co.uk/companies/ceo_focus/424/rick-soni-president-and-coo-of-rexahn-pharmaceuticals-talks-to-proactiveinvestors-424.html Mon, 26 Apr 2010 00:00:00 +0100 http://www.proactiveinvestors.co.uk/companies/ceo_focus/424/rick-soni-president-and-coo-of-rexahn-pharmaceuticals-talks-to-proactiveinvestors-424.html <![CDATA[Rexahn Pharmaceuticals to present pre-clinical data for anti-cancer compound at AACR Annual Meeting ]]> http://www.proactiveinvestors.co.uk/companies/news/15611/rexahn-pharmaceuticals-to-present-pre-clinical-data-for-anti-cancer-compound-at-aacr-annual-meeting-15611.html Rexahn Pharmaceuticals Inc (AMEX: RNN) announced it will present pre-clinical data on its anti-cancer compound RX-8243 at the American Association for Cancer Research's (AACR) 101st Annual Meeting on April 17 2010 at the Walter E. Washington Convention Center in Washington, DC.

During the “Experimental and Molecular Therapeutics” session, the company will display the data entitled “Characterization of a novel small molecule with potent anticancer activity”.

RX-8243 is a novel isoquinolinamine analogue that inhibits Ark1 (Aurora A) kinase and other Ser/Thr kinases implicated in cancer progression.

According to Rexahn, pre-clinical studies demonstrated that RX-8243 blocked tumor growth in xenograft models at low nanomolar concentrations. These studies also have shown RX-8243 to be more effective against paclitaxel, gemcitabine and cisplatin-resistant cancer cell lines when compared to the original cytotoxic cancer drugs, the company states.

RX-8243 is part of a robust pipeline of pre-clinical anti-cancer compounds that Rexahn has developed to provide higher efficacy and to improve the quality of life and survival of patients.

Rexahn is a clinical stage biopharmaceutical company, commercializing oncology and central nervous system (CNS) therapeutics. Rexahn’s core scientific expertise is in signal transduction; this has produced a drug portfolio with significant potential clinical value.

The company is working on a variety of therapeutics for cancer, CNS disorders, sexual dysfunction and other unmet medical needs. The company currently has three drug candidates in Phase II clinical trials, Archexin, Serdaxin, and Zoraxel and a robust pipeline of preclinical compounds to treat multiple cancers and CNS disorders.

One of the company most advanced development products is Serdaxin, which according to Rexahn prevents neuronal death which is a disease mechanism implicated in many brain disorders from depression to Parkinson’s and Alzheimer’s diseases. The treatment protects dopamine-releasing neurons from environmental damage. Serdaxin directly targets the disease mechanism by slowing or halting the progression of the disease, Rexahn state.

Separately, Rexahn is currently investigating Serdaxin as a treatment for depression in Phase II clinical trials.

The company has multiple clinical programs planned for investigating Serdaxin in the treatment of anxiety disorders, Parkinson’s disease, Alzheimer’s disease and neurodegenerative illnesses, neuro-protection and bio-defense uses.

]]> Thu, 15 Apr 2010 16:38:00 +0100 http://www.proactiveinvestors.co.uk/companies/news/15611/rexahn-pharmaceuticals-to-present-pre-clinical-data-for-anti-cancer-compound-at-aacr-annual-meeting-15611.html <![CDATA[Rexahn Pharmaceuticals clarifies purpose and results of Serdaxin clinical trial ]]> http://www.proactiveinvestors.co.uk/companies/news/15564/rexahn-pharmaceuticals-clarifies-purpose-and-results-of-serdaxin-clinical-trial-15564.html Rexahn Pharmaceuticals (AMEX: RNN) said that yesterday’s Phase IIa clinical results for Serdaxin un-ambiguously reached the conclusion that patients, especially those suffering from severe depression, respond positively. Today, the company has provided additional information on the trials results.

The Phase IIa clinical results were for the Serdaxin drug, in the treatment of major depressive disorder (MDD).

“Based on the feedback and reaction from our shareholders, stakeholders and other market participants, it is clear that neither the purpose of the Serdaxin trial or its results were well understood,” Rexahn chief executive Dr Chang Ahn stated.

“Some market participants have asked us why our overall trial results were not statistically significant. The answer is simply that the Serdaxin study was never designed to achieve statistical significance as a primary objective, but rather to establish a positive signal among treated patients”.

The study showed that patients with severe major depressive disorder MDD taking 5 mg of Serdaxin (55.6%) had statistically significant improvement in Montgomery-Asberg Depression Rating Scale (MADRS) scores after 8 weeks of treatment, compared to placebo (34.0%), Rexahn stated.

“The purpose of the Serdaxin Phase IIa trial was to establish as a proof of concept that Serdaxin can work as an antidepressant drug for patients suffering from Major Depressive Disorder. I am happy to say that this is exactly what the study accomplished”, Dr Ahn added.

Furthermore, the company is extremely pleased with Serdaxin’s Phase IIa clinical trial, which Rexahn said should be viewed as a success. As such, based on the strength of the results, Rexahn is now planning to move forward with a 300 patient phase IIb clinical trial in the second half of 2010. “We believe this study will further substantiate Serdaxin as a viable treatment for depression,” Dr Ahn concluded.

Earlier this month, the company submitted a Phase II protocol to the US Food and Drug Administration (FDA) for the clinical study of Serdaxin, in another indication, for the treatment of Parkinson’s disease (PD). Rexahn believes that Serdaxin is a potential market-leading CNS (Central Nervous System) drug acting as a neuro-protective agent and an antidepressant.

According to Rexahn, Serdaxin prevents neuronal death which is a disease mechanism implicated in many brain disorders from depression to Parkinson’s and Alzheimer’s diseases. The treatment protects dopamine-releasing neurons from environmental damage. Serdaxin directly targets the disease mechanism by slowing or halting the progression of the disease, Rexahn state.

]]> Wed, 14 Apr 2010 16:26:00 +0100 http://www.proactiveinvestors.co.uk/companies/news/15564/rexahn-pharmaceuticals-clarifies-purpose-and-results-of-serdaxin-clinical-trial-15564.html <![CDATA[Rexahn Pharmaceuticals submits Phase II study protocol for Serdaxin to US FDA ]]> http://www.proactiveinvestors.co.uk/companies/news/15245/rexahn-pharmaceuticals-submits-phase-ii-study-protocol-for-serdaxin-to-us-fda-15245.html Rexahn Pharmaceuticals (AMEX: RNN) has submitted a Phase II protocol to the US Food and Drug Administration (FDA), for the clinical study of Serdaxin in the treatment of Parkinson’s disease (PD). Rexahn believes that Serdaxin is a potential market-leading CNS (Central Nervous System) drug acting as a neuro-protective agent and an antidepressant.

Parkinson’s disease is a common movement disorderaffecting more than 5 million patients worldwide, characterized by the progressive loss of dopaminergic neurons in the brain. This can ultimately result in several serious symptoms affecting the patient’s motor-skills, such as muscle stiffness, a slowing of movement, an unstable posture and muscle tremors. These physical impairments are also accompanied by non-motor disabilities including dementia, depression, and sleep disturbance.

“Although there are currently various treatment options for PD, a meaningful cure is overdue”, Rexahn chief executive Dr Chang Ahn commented. “Based on Serdaxin’s novel action as a dual serotonin and dopamine enhancer, we believe it has the potential to be the first drug of its kind to target both the classic symptoms of PD and treat the depression so often associated with this disease”.

According to Rexahn, Serdaxin prevents neuronal death which is a disease mechanism implicated in many brain disorders from depression to Parkinson’s and Alzheimer’s diseases. The treatment protects dopamine-releasing neurons from environmental damage. Serdaxin directly targets the disease mechanism by slowing or halting the progression of the disease, Rexahn state.

Separately, Rexahn is currently investigating Serdaxin as a treatment for depression in Phase II clinical trials.

“Serdaxin has demonstrated an ability to prevent neuronal deaths in PD models, and the drug’s positive Phase IIa results in depression further enhance its promise as a treatment for PD”, Dr Chang Ahn added.

The Phase II study will assess Serdaxin’s efficacy as a treatment for Parkinson’s disease in approximately 300 subjects, the trial will include the Unified Parkinson’s Disease Rating Scale (UPDRS) and quality of life instruments as study endpoints and will be conducted at multiple sites.

Separately, Rexahn has also has formed a Parkinson’s Scientific Advisory Board (SAB) composed of leading medical researchers in the field of neurology, who will advise on the design and development of the Serdaxin clinical trials. The SAB is being chaired by Dr. William Weiner, the head of the University of Maryland’s Parkinson’s Disease and Movement Disorders Center.

"We believe that Serdaxin's properties in animal models open exciting possibilities as a new treatment for patients with PD. All the members of the SAB will be actively engaged in Serdaxin's clinical development, which we hope will further establish the drug's efficacy in treating PD", Weiner commented.

Rexahn believes that Serdaxin may achieve greater and broader therapeutic coverage, and said that it appears to have no serious side effects such as nausea, vomiting, insomnia, weight gain, sexual dysfunction, cognitive deficit or motor impairment that are linked to existing antidepressant drugs. Serdaxin has a well-established, excellent human safety profile.

The company has multiple clinical programs planned for investigating Serdaxin in the treatment of anxiety disorders, Parkinson’s disease, Alzheimer’s disease and neurodegenerative illnesses, neuro-protection and bio-defense uses.

Primarily, Rexahn is a clinical stage pharmaceutical company dedicated to commercializing first in class and market leading therapeutics for cancer, CNS disorders, sexual dysfunction and other unmet medical needs. The company currently has three drug candidates in Phase II clinical trials, Archexin, Serdaxin, and Zoraxel and a robust pipeline of preclinical compounds to treat multiple cancers and CNS disorders.

]]> Tue, 06 Apr 2010 14:02:00 +0100 http://www.proactiveinvestors.co.uk/companies/news/15245/rexahn-pharmaceuticals-submits-phase-ii-study-protocol-for-serdaxin-to-us-fda-15245.html <![CDATA[What’s All the Excitement About Rexahn Pharmaceuticals? ]]> http://www.proactiveinvestors.co.uk/companies/news/15174/whats-all-the-excitement-about-rexahn-pharmaceuticals--15174.html By Gene Marcial, cpreports.com

If you believe that the unsung biotechs will finally have their day in the sun, you are right on the money. The smart-money crowd is betting that this year, it will be the biotech stocks that will provide the leadership among the small-caps. In fact, some budding late-development stage pharmaceuticals are already displaying impressive strength.

One in particular is the still undiscovered Rexahn Pharmaceuticals, trading on the AMEX with the ticker symbol RNN, which has zoomed from a 52-week low of 40 cents share on Sept. 2, 2009, to $1.62 on Mar. 30, 2010.

That sharp upswing may be a prognosticator of what lies ahead for the stock. Some close watchers of the company, which is developing signal inhibitor therapies for cancer and treatments for central nervous system diseases, predict that Rexahn will  bounce back to its 52-week high of $2 a share reached on May 12, 2009 — If not higher – sometime this year. Analyst Elemer Piros of investment firm Rodman & Renshaw, who rates the stock outperform, sees it climbing to $2 a share this year.  

What’s behind the excitement over the stock? Rexahn has a number of promising drugs in its pipeline and one that’s catching a lot of attention on Wall Street is Serdaxin, a treatment for depression and mood disorders. Management is expected to release sometime in the second quarter the results of the Phase IIA clinical trials. The results are expected to be very positive.

“We believe the results of this trial will be extremely positive, demonstrating considerable efficacy,” says Rob Goldman of the Goldman Small-Cap Research, who rates the stock a “speculative buy, with a target of $4 a share. The results could lead to an eventual partnership with a major pharmaceutical company, he says. “with a flurry of favorable news ahead, we expect the stock wil begin to garner significant attention and a higher valuation in the coming months,” says Goldman.

Top Rexahn executives are believed to be in serious talks with at least five large drug makers on a possible partnership deal for the production and commercialization of Serdaxin. There is serious interest by the major pharmaceuticals in Serdaxin because it addresses a huge $18 billion market, says one Rexahn insider. The company is also expected to submit a protocol to the Food and Drug Administration for the first studies of Serdaxil as a treatment for Parkinson’s disease.

Already, Rexahn has a partnership agreement with Teva Pharmaceuticals, one of the largest drug makers in the world, which has invested some $3.5 million to co-develop the company’s anti-cancer compound named RX-3117. The drug has therapeutic potential for the treatment of a broad range of cancers, including colon, lung, and pancreatic cancer, says Goldman. Rexahn is expected to receive a total of $200 million from Teva in milestone payments for RX-3117 over a period of time.
 
Based on the Teva parrtnership model, Rexahn could get some $750 million in milestone payments for Sersdaxin from a major pharmaceutical company that will parrtner with Rexhan, according to a source close to the company. With that kind of a milestone payment to a company whose market cap is just $115 million, Rexahn's stock could be several multiples higher from where it is today.       

Rexahn has two other drug candidates that are in phase II trials: Zoraxel, a treatment for erectile dysfunction, and Archexin, a treatment fro metastatic pancreatic cancer.

Zoraxel, unlike other existing treatments for erectile dysfunction, is a central nervous system based mechanism that acts as a dual enhancer of serotonin and dopamine in the brain, where the neurotransmitters play a key role in sexual activity, notes Goldman. Rexahn believes Zoraxel may be the first erectile dysfunction drug to affect all three phases of sexual activity – sexual motivation, arousal, and erection. Another significant aspect of the drug: It has a potential to also treat female sexual dysfunction, according to the company’s research.   

Archexin is a first-in-class potent inhibitor of the Akt-1 protein kinase in cancer cells, and has been granted by the Food and Drug Administration a orphan drug designation for five cancers – renal cell carcinoma, glioblastoma, and cancers of the stomach, ovary, and pancreas, notes Goldman.

For a small, little known company, Rexahn could, indeed, become a significant player in the universe of biotechs with its rich  pipeline of new drugs. The next catalyst for the stock is the release of the results of the phase IIA trials on Serdaxil. And once a partnership is announced for Serdaxn, expect the stock to soar.

 

 

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Featured on CPreports.com is Gene Marcial’s “Inside Wall Street” column, written by the guru who has been providing insights into large and smallcap investment strategies for over 28 years through his columns in BusinessWeek and the Wall Street Journal. 

 

]]> Thu, 01 Apr 2010 14:42:00 +0100 http://www.proactiveinvestors.co.uk/companies/news/15174/whats-all-the-excitement-about-rexahn-pharmaceuticals--15174.html <![CDATA[Rexahn Pharmaceuticals discovery platform continues to churn out potential blockbuster compounds ]]> http://www.proactiveinvestors.co.uk/companies/news/14997/rexahn-pharmaceuticals-discovery-platform-continues-to-churn-out-potential-blockbuster-compounds-14997.html Rexahn Pharmaceuticals (Amex: RNN) is a clinical stage biopharmaceutical company commercializing best in class oncology and central nervous system (CNS) therapeutics. Chang Ahn, the founder of Rexahn Pharmaceuticals, lost his sister to stomach cancer in January of 1990. This drove Dr. Ahn’s passion to find a cure, which eventually positioned Rexahn as a leading biopharmaceutical company developing and delivering novel therapies for cancer and disorders of the central nervous system. Rexahn’s core scientific expertise is in signal transduction; this has produced a drug portfolio with significant potential clinical value. 

The Company’s research determined that by “tuning” the cell signaling pathways to shut down the uncontrolled cell growth that results in cancer, they could similarly tune the cell signaling pathways related to CNS-based conditions such as Parkinson’s, Alzheimer’s, depression, and sexual dysfunction. Rexahn has three drug candidates in various stages of Phase II clinical trials.

·    Archexin® - a first-in-class AKT inhibitor therapy for treating various cancers, such as pancreatic cancer, renal cell carcinoma, glioblastoma, and cancers of the ovary and stomach.
·    Serdaxin® - a best-in-class therapy for treating depression, and potentially break-through treatment for Parkinson’s and Alzheimer’s.
·    Zoraxel™ - a first-in-class CNS-based therapy for treating sexual dysfunction.

Discovery Platform - Rexahn owns a highly productive discovery platform that continues to yield a portfolio rich in potential first-in-class and best-in-class compounds. The discovery platform features a first-in-class small molecule drug discovery (TIMES, “The Inhibitors of Multi-Expression Signals”), highly integrated computational modeling (3D-GOLD, “3D-Gateway of Ligand Discovery”) and nano-based drug targeting and delivery. Working in concert, these technologies enable the Company to screen, select, and optimize large numbers of compounds while retaining stringent selection criteria. Rexahn’s R&D pipeline success is largely due to its R&D platforms, which has demonstrated greater efficacy with fewer side effects.


Overview

Rexahn’s pipeline, scientific and business goals for 2010 are:

·    Advance Serdaxin in a Phase IIb clinical trial in depression. In October 2009, Rexahn reported top-line Phase IIa clinical results for Serdaxin for Major Depressive Disorder (MDD). The study demonstrated that patients ages 18-65 with MDD exhibited clinically significant improvement over baseline in symptoms of depression. Serdaxin exhibited an onset of action in less than two weeks and was found to be safe and well tolerated, without any of the serious side effects often linked to currently marketed antidepressant drugs.


·    Expand clinical development of Serdaxin to Parkinson’s disease. Current animal model studies demonstrate that Serdaxin protects neuronal cells from death, of which death is a key mechanism implicated in many brain disorders such as Parkinson’s and Alzheimer’s. In a Parkinson’s disease animal model, Serdaxin has proven to be a powerful neuroprotective agent and has significant potential as a next-generation drug for disease-modifying treatment that goes beyond the dopamine replacement schemes often used in current treatments. Additionally, an MRI study exhibited stronger neuronal activity in dopamine and serotonin systems in Serdaxin-treated animals. Rexahn expects to begin a Phase II clinical trial for Parkinson’s in the second quarter of 2010.


·    Advance clinical development of Zoraxel for sexual dysfunction. In the first half of 2010, Rexahn expects to submit a protocol to the FDA for a Zoraxel Phase IIb clinical study for male 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 showed improved erectile function and quality of life during the 8-week treatment period.


·    Continue clinical development of Archexin for the treatment of pancreatic cancer. Archexin is a potent AKT protein kinase inhibitor with potential utility to inhibit cancer cell survival and proliferation, angiogenesis and drug resistance. The drug is currently being studied in Phase II clinical trials for pancreatic cancer. Rexahn expects to complete it by the end of 2010. In previous clinical studies, Archexin has demonstrated an excellent human safety profile, with fatigue being the only noticeable side effect. Archexin has FDA Orphan drug designation for five different cancer types; renal cell carcinoma, glioblastoma, pancreatic, stomach, and ovarian cancers.


·    Initiate clinical program for RX-3117. Rexahn and its partner Teva Pharmaceutical Industries, one of the largest pharmaceutical firms in the world, are co-developing novel anti-cancer compound, RX-3117, for the treatment of cancer, in particular, gemcitabine-resistant lung and pancreatic cancers. RX-3117 has shown potent anti-tumor effects in xenograft human tumor models. Preclinical studies have revealed the compound’s high bioavailability and superior safety profile to gemcitabine, which is the current first-line therapy for pancreatic and other cancers. Rexahn and Teva expect to begin human clinical trials for RX-3117 in late 2010. Teva is scheduled to invest millions of dollars into Rexahn. Teva’s investment into the Company is contracted to be at a 20% premium to the then current market price. The Company will also receive roughly $4 million milestone fee in 2010 if a set of milestones are achieved. The Teva partnership illustrates and validates the underlying, hidden value of the Rexahn’s pipeline drugs, even in the pre-clinical stage. Rexahn is expected additional partnerships for later stage products over the next 6-12 months.

Financial

Major shareholders in Rexahn, in addition to insiders, are a top 5 pharmaceutical company, the largest pharmacy chain, and the leading tobacco company in Korea. These "closely held" investors account for holding 80% of the company's outstanding shares.

As of December 31, 2009, the Company was burning $1.8 million in cash per quarter and had:
·    $10 million in cash
·    Assets of $10 million
·    Equity of $8 million

Top Three Drugs in the Pipeline

Serdaxin® – Depression and Parkinson’s disease - Unlike other treatments for depression and mood disorders, Serdaxin tackles three mechanisms simultaneously: serotonin, dopamine, and neuronal survival. Serdaxin is a game-changing mood disorder drug in a huge market filled with major players (Pfizer, Eli-Lilly, GSK). Among antidepressants, SSRIs/SNRIs appear to be the leading therapy but are only partially effective and have a 50% estimated response rate and up to 30% relapse rate. Serdaxin aims to change all of that. Previous research indicates that loss of serotonin in the brain underlies common symptoms such as anxiety.

Recent findings, however, indicate that dopamine plays a central role in other aspects of the disease, including anhedonia (loss of pleasure) and lack of motivation. In preclinical studies, Serdaxin supports both serotonergic and dopaminergic systems in the brain, enabling a multi-prong approach to treating depression. In the next four years, over $5 billion of the $11 billion anti-depressant market will come off patent protection. This means that Serdaxin has perhaps the best shot at replacing those compounds and expanding the market for patients who did not do well on Prozac or Zoloft.

In addition, Serdaxin prevents neuronal death, a disease mechanism implicated in many brain disorders from depression to Parkinson’s and Alzheimer’s diseases. In a Parkinson’s disease animal model, Serdaxin protects dopamine-releasing neurons from environmental damage. This result supports the Company’s hypothesis that Serdaxin is a long-awaited neuroprotective agent and potential next-generation treatment that goes beyond dopamine replacement.

Zoraxel is a developmental stage drug for sexual dysfunction that directly modulates the sexual activity control center in the brain. Zoraxel enhances the action of serotonin and dopamine, brain signaling molecules that play a key role in three phases of male sexual activity: arousal, erection and release. Zoraxel is the first erectile dysfunction (ED) therapeutic to affect all three of these phases. Unlike PDE-5 inhibitors (Viagra, Cialis and other ED drugs) that only address blood flow issues and thus peripherally acting, Zoraxel is centrally acting in the brain affecting all three functions of male sexual activity. Roughly half the patients who suffer from sexual dysfunction do not respond to Viagra.

Preclinical studies demonstrated Zoraxel improves sexual performance via enhanced motivation and arousal. Its centrally acting mechanism also warrants potential use in the treatment of female sexual dysfunction. Zoraxel also has superior safety compared to PDE-5 inhibitors. Considering all these, Zoraxel has multi-billion dollar blockbuster potential.

Archexin has US FDA orphan drug designation for five cancers (RCC, glioblastoma, and cancers of the ovary, stomach and pancreas). Multiple indications for other solid tumors may also be pursued. In preclinical studies, Archexin significantly reduced AKT in cancer cells of many human solid tumors. Once again, a multi-billion dollar blockbuster is possible.

Archexin is an antisense oligonucleotide compound that is highly selective for inhibiting mRNA expression and production of Akt protein. Akt activation leads to cancer cell survival, proliferation, angiogenesis, and drug resistance.  Both native and activated forms of Akt are involved in cancer cell signaling. Archexin is the first anticancer drug that inhibits both native and activated forms of Akt, with the potential to inhibit cancer survival and proliferation, angiogenesis, and drug resistance. In the Archexin Phase I clinical study, grade 3 fatigue was the only dose limiting toxicity observed.

The goal of the ongoing Phase II trial is to assess efficacy and safety in treating metastatic pancreatic cancer. The primary study endpoints are tolerability and survival. Preliminary results of the Phase II clinical trial for the use of Archexin in pancreatic cancer is expected in late 2010.

Summary

With three drugs of significant potential in Phase II trials and a number of other compounds in various stages of development, Rexahn is much more diversified than many small dug companies that typically rely on one or two drugs. With the pharmaceutical partnership as well as long-term Korean institutional and corporate shareholders in the company, Rexahn is well positioned for the foreseeable future.

]]> Mon, 29 Mar 2010 13:50:00 +0100 http://www.proactiveinvestors.co.uk/companies/news/14997/rexahn-pharmaceuticals-discovery-platform-continues-to-churn-out-potential-blockbuster-compounds-14997.html <![CDATA[Rexahn Pharma sets up advisory board to assist with anti-Parkinson’s drug development ]]> http://www.proactiveinvestors.co.uk/companies/news/14779/rexahn-pharma-sets-up-advisory-board-to-assist-with-anti-parkinsons-drug-development-14779.html Rexahn Pharmaceuticals (NYSE Amex: RNN) has announced the formation of its Parkinson’s Disease Scientific Advisory Board (SAB), which will collaborate with Rexahn on the clinical development strategy for its central nervous system (CNS) drug candidate Serdaxin.

The board will feature some of the leading medical researchers in neurology including Director of Maryland’s Parkinson’s Disease and Movement Disorders Center, William Weiner, who will act as chairman of SAB. Weiner has been involved in Parkinson’s disease medical research for over 40 years and has published over 200 peer reviewed articles and 20 textbooks on the disease and related disorders.

Weiner will be joined by Kenneth Marek, MD, President and Senior Scientist at the Institute for Neurodegenerative Disorders, New Haven, Connecticut. He serves on the scientific advisory board of the Michael J Fox Foundation.

Also joining the SAB is Andrew Feigin, MD, Professor, at Departments of Molecular Medicine and Neurology At Hofstra University School of Medicine. Dr. Feigin has 18 years experience in the design and conduct of clinical trials for Parkinson’s disease.

The fourth member is Fernando Pagan, MD, Associate Professor of Neurology at Georgetown University Hospital (GUH). He is also Co-Director of the Movement Disorders Program and Medical Director of National Parkinson Foundation Center of Excellence at GUH.

“With Serdaxin, Rexahn is developing a promising therapeutic for Parkinson’s disease, a condition in great need of effective treatment options. I am excited to help contribute to the design of Serdaxin’s clinical trials and ultimately to help guide this promising drug into the clinic, where it may one day help treat patients suffering from this debilitating illness,” said Weiner.

Serdaxin is one of the company’s two most advanced drugs, currently approaching the conclusion of its Phase II trial. The company states that its drugs have the potential to “change the paradigm of how some cancers and CNS disorders are treated, not only providing patients with new cures, but also hope for a better quality of life,” with its Phase II drugs targeting diseases where “meaningful cures” are overdue.

Rexahn’s two other drug candidates currently undergoing Phase II clinical trials are Zoraxel, which treats sexual dysfunction, and Archexin, an AKT-inhibitor therapy for treating various cancers, such as pancreatic cancer, renal cell carcinoma (RCC), glioblastoma, and cancers of the ovary and stomach.

The company has said that all of these three drugs are all potentially best-in-class therapeutics.

]]> Tue, 23 Mar 2010 14:57:00 +0000 http://www.proactiveinvestors.co.uk/companies/news/14779/rexahn-pharma-sets-up-advisory-board-to-assist-with-anti-parkinsons-drug-development-14779.html