Rexahn Pharmaceuticals, Inc. (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. Current clinical studies demonstrate that Serdaxin prevents neuronal death, a disease mechanism implicated in many brain disorders, such as Parkinson’s and Alzheimer’s disease. 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 treatment that goes beyond the dopamine replacement schemes often used in current treatments. Additionally, a functional magnetic resonance imaging (fMRI) study exhibited stronger neuronal activity in dopamine and serotonin systems in Serdaxin-treated animals. Rexahn expects to begin a Phase II clinical trial in Parkinson’s disease in the second quarter of 2010.
- Advance Serdaxin in Phase IIb clinical study for depression. Rexahn plans to advance Serdaxin in a Phase IIb clinical trial in depression. In October 2009 Rexahn reported top-line Phase IIa clinical results for Serdaxin for MDD. The study demonstrated that patients ages 18-65 with MDD exhibited clinically meaningful improvement over baseline in symptoms of depression as measured by the Montgomery-Asberg Depression Rating Scale (MADRS) total score. 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.
- 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. Archexin is a first in class, potent Akt protein kinase inhibitor with potential utility to inhibit cancer cell survival and proliferation, angiogenesis, and drug resistance and is currently being studied in Phase II clinical trials in pancreatic cancer. Rexahn expects to complete these trials 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, including renal cell carcinoma, glioblastoma, pancreatic, stomach and ovarian cancers.
- Initiate clinical program for RX-3117. Rexahn and partner Teva Pharmaceutical Industries are co-developing novel anti-cancer compound, RX-3117, for the treatment of cancer, in particular, gemcitabine-resistant lung cancer. 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 Q4 2010.
- Form new partnerships. Rexahn seeks to form new product collaborations in addition to the partnership with Teva Pharmaceutical Industries; scientific platform alliances to maximize the utility of the Company’s three powerful discovery platforms; and research collaborations to further expand the pipeline candidates.
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