NeurogesX Announces Presentation of Positive Phase 3 Clinical Data at the Second International Congress on Neuropathic Pain Meeting (NeuPSIG)
SAN CARLOS, Calif., June 07, 2007 /PRNewswire-FirstCall/ -- NeurogesX, Inc. announced today the presentation of clinical data from a positive Phase 3 trial in postherpetic neuralgia (PHN). Misha-Miroslav Backonja, M.D., Professor of Neurology at University of Wisconsin in Madison and lead academic investigator in the NeurogesX trial, plans to present the results of the study in a June 8 poster session at the Second International Congress on Neuropathic Pain in Berlin, Germany. Dr. Backonja's poster presentation is based on an abstract titled, "Localized Treatment with NGX- 4010 Significantly Reduced Pain for up to 12 Weeks: Results of A Randomized, Double-Blind, 12-Week Controlled Study in Postherpetic Neuralgia Patients."
The study evaluated the effect of a single application of NGX-4010, the Company's novel dermal patch, on pain due to PHN. The primary endpoint in this Phase 3 trial was achieved, demonstrating a statistically significant reduction in pain over an 8-week period (NGX-4010, -29.6% vs. control, -19.9%; p = 0.001). The reduction of pain was sustained over 12 weeks (NGX-4010, -29.9% vs. control, -20.4%; p=0.0016).
"The results of this pivotal Phase 3 trial demonstrate NGX-4010 is effective both alone and in combination with other neuropathic pain medications for the treatment of PHN," said Dr. Backonja. "We believe that NGX-4010's unique profile has the potential to provide a meaningful therapeutic alternative to traditional therapies that need to be taken daily, most of which have systemic side effects."
According to the Centers for Disease Control, there are approximately 1.0 million cases of shingles in the United States each year, and approximate one in five shingles sufferers go on to develop PHN. People with PHN experience pain and increased sensitivity of the skin that can persist for many years.
NeurogesX plans to complete a confirmatory Phase 3 trial in PHN in the second half of 2007 and expects to submit marketing applications to the European Medicines Agency in 2007 for European Union approval and to the U.S. Food and Drug Administration (FDA) in 2008.
NGX-4010 is a physician-administered dermal patch containing a TRPV1 agonist which targets small nerve fibers in the skin at the site of neuropathic pain. Clinical studies to date indicate that a single 30 or 60 minute administration of NGX-4010 may result in clinically meaningful pain relief for up to 12 weeks. NGX-4010 is designed to work locally in the skin without significant absorption into the bloodstream, possibly allowing users to avoid the side effects of current treatment options, such as anti- convulsants, anti-depressants and opioids.
NeurogesX is a biopharmaceutical company focused on developing novel pain management therapies. The Company's initial focus is on chronic peripheral neuropathic pain, including PHN, painful HIV-distal sensory polyneuropathy (HIV-DSP), and diabetic neuropathy. NeurogesX's late stage product portfolio is led by product candidate NGX-4010, a dermal patch designed to manage pain associated with peripheral neuropathic pain conditions that offers significant advantages over other pain therapies. Two Phase 3 trials with NGX-4010 have been completed and have met their primary endpoints, one in PHN and one in HIV-DSP. NGX-4010 has been granted Orphan Drug and Fast Track Status for HIV-DSP by the FDA.
Safe Harbor Statement
This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the "Act"). NeurogesX disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Safe Harbor for forward-looking statements contained in the Act. Examples of such statements include, but are not limited to, statements relating to the filing for regulatory approvals and the timing of such filings; the successful completion of clinical trials with respect to NeurogesX' lead product candidate, NGX-4010; and market acceptance of NGX- 4010. Such statements are based on management's current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to, patient enrollment for clinical trials may be difficult; past results of clinical trials may not be indicative of future clinical trials results; NeurogesX' product candidate may have unexpected adverse side effects or inadequate therapeutic efficacy; positive results in clinical trials may not be sufficient to obtain FDA or European regulatory approval; physician or patient reluctance to use NGX-4010, if approved, or the inability of physicians to obtain sufficient reimbursement for such procedures; potential alternative therapies; maintaining adequate patent or trade secret protection without violating the intellectual property rights of others; and other difficulties or delays in clinical development, obtaining regulatory approval, market acceptance and commercialization of NGX-4010. For further information regarding these and other risks related to NeurogesX' business, investors should consult NeurogesX' filings with the Securities and Exchange Commission.
NeurogesX Stephen Ghiglieri (650) 508-2116 The Ruth Group Investors / Media Stephanie Carrington / Janine McCargo (646) 536-7017 / firstname.lastname@example.org email@example.com
CONTACT: Stephen Ghiglieri of NeurogesX, +1-650-508-2116; or Investors,Stephanie Carrington, +1-646-536-7017, , orMedia, Janine McCargo, +1-646-536-7033, , both ofThe Ruth Group firstname.lastname@example.org email@example.com
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Posted: June 2007