SAN MATEO, Calif., July 11 /PRNewswire-FirstCall/ -- NeurogesX, Inc. , a biopharmaceutical company focused on developing and commercializing novel pain management therapies, announced the initiation of its Phase 1 clinical trial (study C203) of NGX-1998. The product candidate is a high-concentration, capsaicin-based liquid formulation designed to deliver a localized therapeutic dose directly to the pain site.
The randomized, single-blind Phase 1 trial is designed to evaluate potential control formulations for future NGX-1998 clinical trials. NeurogesX expects to complete the trial by the end of 2008.
Anthony DiTonno, President and CEO of NeurogesX, commented, "The initiation of this Phase 1 trial of NGX-1998 marks a significant step in our program to develop a second-generation liquid formulation of capsaicin to manage pain. We believe that our Phase 1 trial will provide us with important information that will help shape the design of further studies with the product candidate. We are pleased with the Company's progress with NGX-1998 advancing in the clinic and NGX-4010 under regulatory review in Europe and approaching NDA submission in the United States."
About NGX-1998
NGX-1998 is a topically applied, high-concentration liquid formulation of capsaicin designed to treat pain associated with neuropathic pain conditions. The objective of the NGX-1998 development program is to determine the ability of NGX-1998 to provide protracted pain relief from a single treatment. Similar to NGX-4010, the Company's late-stage dermal patch that also contains a high concentration of capsaicin, NGX-1998 is designed to deliver localized pain relief however, with a shorter treatment procedure time and potentially with reduced treatment-related discomfort than NGX-4010. NGX-1998, because it is a liquid, is expected to be able to address areas of the skin where dermal patches may be difficult or impractical to apply, such as the hairline. Additionally, the goal of the NGX-1998 program is to develop a product with a treatment procedure that would potentially allow its use by a greater variety of physicians than NGX-4010, including primary care physicians. NGX-1998 was previously studied in two Phase I studies in healthy volunteers conducted under an exploratory investigational new drug application.
About NeurogesX, Inc.
NeurogesX is a biopharmaceutical company focused on developing and commercializing novel pain management therapies. Its initial focus is on chronic peripheral neuropathic pain, including postherpetic neuralgia (PHN), painful HIV-distal sensory polyneuropathy (HIV-DSP) and painful diabetic neuropathy (PDN). NeurogesX' late stage product portfolio is led by its product candidate NGX-4010, a dermal patch designed to manage pain associated with peripheral neuropathic pain conditions, that the Company believes offers significant advantages over other pain therapies. NeurogesX' marketing authorization application (MAA) to the European Medicines Agency (EMEA) was accepted for review in September 2007 and NeurogesX plans to file a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) in 2008 for PHN.
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, the timing of the completion of the Phase 1 clinical trial for NGX-1998; the potential to treat additional indications and skin locations with NGX-1998 than are currently targeted by NGX-4010; and the expected benefits of NeurogesX' potential products, including its liquid formulation product candidate NGX-1998 and its lead product candidate 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, 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 or NGX-1998, 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 or NGX-1998 and the advantages of NGX-4010 or NGX-1998 over other pain therapies. For further information regarding these and other risks related to NeurogesX' business, investors should consult NeurogesX' filings with the Securities and Exchange Commission.
CONTACT: Stephen Ghiglieri of NeurogesX, +1-650-358-3310,
sghiglieri@neurogesx.com; or Investors, Stephanie Carrington,
+1-646-536-7017, scarrington@theruthgroup.com, or Media, Jason Rando,
+1-646-536-7025, jrando@theruthgroup.com, both of The Ruth Group
