Healthcare Industry News: shingles
News Release - June 11, 2007
NeurogesX Completes Enrollment in Phase 3 Clinical Trial for Postherpetic NeuralgiaPhase 3 Trial for PHN Progressing on Schedule
SAN CARLOS, Calif., June 11 (HSMN NewsFeed) -- NeurogesX, Inc. (Nasdaq: NGSX ) announced today that it has completed enrollment in study C117, a second Phase 3 clinical trial of its lead product candidate NGX-4010, for the treatment of postherpetic neuralgia (PHN). NGX-4010 is a dermal patch designed to manage peripheral neuropathic pain. Previously completed Phase 3 trials demonstrate 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. C117 is a randomized, double-blind, controlled study that has enrolled over 400 patients at study sites in the United States and Canada.
"We are pleased to have reached another important milestone in our NGX- 4010 program with the completion of enrollment in the C117 trial for postherpetic neuralgia," commented Dr. Jeffery Tobias, Chief Medical Officer. "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 third quarter."
The study protocol evaluates the effect of a single, 60 minute treatment with NGX-4010 or a low-concentration control patch applied directly to the patient's site of pain. The treatment is administered by the physician during an in-office procedure. After one hour, the study patch is removed and the patient's response to treatment is evaluated during the subsequent 12-week study period.
"Completing enrollment in the C117 study reinforces our ability to manage late stage clinical trials," said Anthony A. DiTonno, President and CEO. "With this milestone, we feel that we are one step closer to potential commercialization of our lead product, NGX-4010."
NeurogesX has previously successfully completed Phase 3 studies in PHN and HIV-distal sensory polyneuropathy (HIV-DSP). NGX-4010 has been granted Orphan Status and received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the HIV-DSP indication. The Company believes that successful completion of one or more of the ongoing Phase 3 studies in PHN or HIV-DSP will enable it 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 (Nasdaq: NGSX ) 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's late stage product portfolio is led by product candidate NGX-4010, a topical patch designed to manage pain associated with peripheral neuropathic pain conditions, that the company believes offers significant advantages over other pain therapies. Two Phase 3 clinical trials with NGX-4010 have been completed and have met their primary endpoints, one 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 C117 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 filing; and 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. For further information regarding these and other risks related to NeurogesX' business, investors should consult NeurogesX' filings with the Securities and Exchange Commission.
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