SAN CARLOS, Calif., Sept. 21 /PRNewswire-FirstCall/ -- NeurogesX, Inc. announced today that it has completed enrollment in study C119, a second Phase 3 clinical trial of its lead product candidate NGX-4010 for the treatment of painful HIV-distal sensory polyneuropathy (HIV-DSP). NGX-4010 is a dermal patch designed to manage peripheral neuropathic pain. Previously completed Phase 3 trials demonstrated that a single, 30- or 60-minute treatment with NGX-4010 applied directly to the site of pain may provide pain relief for up to three months. C119 is a randomized, double-blind, controlled study that has enrolled over 480 patients at study sites in the United States, the United Kingdom, Australia and Canada.
“We believe that completion of enrollment in our C119 study marks a significant milestone in our NGX-4010 development program in HIV-DSP. We are currently in the follow-up phase of the study and expect to be able to provide top-line results near the end of the first quarter of 2008,” commented Dr. Jeffery Tobias, Chief Medical Officer. “HIV-DSP is an important and underserved problem in patients with HIV/AIDS. There are currently no approved therapies for this indication. With the completion of enrollment in study C119, we are moving closer to our goal of providing an effective treatment for this patient population.”
The study protocol for study C119 evaluates the effect of a single, 30- or 60-minute treatment with NGX-4010 or a low-concentration control patch applied directly to the patient’s site of pain. NGX-4010 is administered by a physician during an in-office procedure. After 30 or 60 minutes, the study patch is removed and the patient’s response to treatment is evaluated during the subsequent 12-week study period.
Anthony A. DiTonno, President and CEO, commented, “I am very pleased with our ability to complete the enrollment of this study ahead of plan. When we completed our initial public offering earlier this year, we indicated that we would file a new drug application (NDA) with the Food and Drug Administration (FDA) in the second half of 2008. Completion of enrollment in this study, on top of our three already completed successful Phase 3 trials, increases our confidence that we can meet this goal.”
NeurogesX has successfully completed two Phase 3 studies in postherpetic neuralgia (PHN) and one in HIV-DSP. NGX-4010 has been granted orphan status and has received fast track designation from the FDA for HIV-DSP. NeurogesX believes that it is on track to file for marketing approval in the European Union before the end of 2007 for a broad indication of peripheral neuropathic pain. The Company is currently evaluating various regulatory filing strategies in the United States in order to most efficiently seek FDA approval of both the PHN and HIV-DSP indications, and believes that it will be able to submit a new drug application with the FDA in 2008.
About PHN and HIV-DSP
PHN is a painful condition affecting sensory nerve fibers. It is a complication of shingles, a second outbreak of the varicella-zoster virus, which initially causes chickenpox. Following an initial infection, some of the virus can remain dormant in nerve cells. Years later, age, illness, stress, medications or other factors that are not well understood can lead to reactivation of the virus. The rash and blisters associated with shingles usually heal within six weeks, but some people continue to experience pain for years thereafter. This pain is known as postherpetic neuralgia. PHN may occur in almost any area, but is especially common on the torso.
HIV-DSP is caused primarily by three factors: direct activation of cells known as sensory neurons by the HIV virus, the immune system’s fight against the infection, and the drugs administered to treat HIV. Painful HIV-DSP is characterized by significant pain in the feet and hands.
About NeurogesX, Inc.
NeurogesX is a biopharmaceutical company focused on developing novel pain management therapies. Its initial focus is on chronic peripheral neuropathic pain, including PHN, painful HIV-DSP and painful diabetic neuropathy. 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. Three Phase 3 clinical trials with NGX-4010 have been completed and have met their primary endpoints, two in PHN and one in HIV-DSP.
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 successful completion of the C119 clinical trial with respect to NeurogesX’ lead product candidate, NGX-4010, including the timing of announcement of results from such trial; filing for regulatory approval and the timing of such filings; the ability to obtain approval for and commercialize 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, 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 and the advantages of NGX-4010 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.
NeurogesX, Inc.
CONTACT: Stephen Ghiglieri of NeurogesX, Inc., +1-650-508-2116; orInvestors: 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 for NeurogesX, Inc.
