Partnering spotlight: Robust pipeline at Rexahn led by three phase II drugs
Reviewing the Rexahn Pharmaceuticals pipeline is like reading about a team of potential medal winning Olympic athletes. Each compound is an innovative or first in class product in its therapeutic segment. Three drugs are currently in Phase II clinical trials to treat cancers, central nervous system disorders, and sexual dysfunction. Further, IND filings for two oncology compounds are planned by 2010.
Rexahn has a robust R&D pipeline, and proprietary drug discovery platform and nano-medicine technologies that further strengthen the commercial best in class potential of its portfolio.
“Our objective is to partner with the world’s leading pharmaceutical companies as part of an overarching commercialization strategy to advance and fund ongoing clinical trials, and leverage scale economies and commercial capabilities of a larger drug company,” said Wendy Tsai, Senior Director of Business Development, who explained that, “We are open to a variety of potential deal structures including strategic alliances, licensing of individual compounds, and co-development/co-commercialization deals.”
Milestones for 2009 include results from a Phase II study of Zoraxel™ treating erectile dysfunction, and enrollment for the Phase II study of Archexin™ treating pancreatic cancer and renal cell carcinoma, as well as for a Serdaxin™ Phase II study.
In February the company initiated the Phase IIA clinical trial for Serdaxin seeking up to 100 patients to evaluate preliminary efficacy in treating major depressive disorder (MDD). The Serdaxin trial is a randomized, double blind, dose ranging and placebo-controlled study conducted at multiple sites in the USA. Preliminary data is expected in early 2010.
Serdaxin is a small molecule, orally available, CNS therapeutic adaptable to treating several neurology and psychiatry disorders. The compound is differentiated by its dual enhancement of serotonin and dopamine levels in the brain, in areas that control or are involved in Parkinson’s disease, depression, and other neurodegenerative disorders. In earlier studies, Serdaxin has attenuated cell death of dopaminergic neurons induced in the MPTP animal model of Parkinson’s disease. Serdaxin has also demonstrated neuroprotective effects in preclinical seizure models of neurotoxicity, and potent activity in rodent models of anxiety, stress, or depression. It has an excellent safety profile, and appears to lack adverse side effects on motor activity, memory, and cognition. With tens of millions of people worldwide suffering from debilitating CNS illnesses, Serdaxin has the potential to be a new medicine and neuroprotective agent.
Zoraxel is a centrally acting sexual dysfunction drug, and may be the first ED drug to affect all three phases of sexual activity, sexual arousal, erection and release. Zoraxel has an excellent safety profile without the side effects caused by the popular PDE-5 inhibitors.
Archexin is a targeted cancer drug and first in class, potent inhibitor of the Akt-1 protein kinase to treat renal cell carcinoma and pancreatic cancer that also features FDA orphan drug designation for glioblastoma and cancers of the ovaries and stomach. Indications for other solid tumors will be pursued.
“These are multi-billion dollar target markets with very high unmet patient needs,” stated Rick Soni, CBO of Rexahn, who said “We believe bringing our first in class products to market will make a significant impact in saving the lives of patients and their quality of life.”
Founded in 2001, Rexahn has a solid track record of collaborations with leading universities and institutions in the USA, Europe, and Korea. Rexahn is publicly traded on the New York Stock Exchange Alternext under the symbol “RNN.”
Related Posts
No related posts.