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NeurogesX, Inc. (Nasdaq: NGSX), a biopharmaceutical company focused on developing and commercializing novel pain management therapies, announced preliminary top-line results from study C119, its second Phase 3 clinical trial of NGX-4010, the Company's dermal patch drug candidate, in patients with HIV-distal sensory polyneuropathy (HIV-DSP). The prespecified analysis of the primary endpoint, comparing all patients treated with NGX-4010 compared to all patients treated with the control patch, did not meet statistical significance (p=0.1), with the overall NGX-4010 treatment group achieving a 29.5% reduction in pain from baseline over weeks 2 to 12 compared to a 24.6% reduction for the control group. The results were confounded by a much higher than anticipated control group response overall and, in particular, in the 60-minute control arm. Dr. Jeffrey Tobias, Chief Medical Officer, commented, "We observed responses in the NGX-4010 treatment arms consistent with what we have seen in multiple previous studies. However, the response in the 60-minute control group was greater than anticipated. We are encouraged that the safety profile of this study supports the lack of any observed major safety issues associated with NGX-4010 and that treatment with NGX-4010 was well tolerated. Since these results are preliminary, we have more analysis to carry out on this data. However, our initial evaluation of the data suggests that the NGX-4010 treatment arms behaved similarly to our other studies and there was a trend in favor of treatment. We will continue to evaluate whether the cumulative clinical data from our clinical studies may be able to support evidence of efficacy in HIV-DSP." The study, a multi-center, double-blind, controlled Phase 3 clinical trial in a total of 494 patients, was similar in design to the Company's previous successfully completed phase 3 study in HIV-DSP. Study C119 contained two treatment arms (30-minute and 60-minute arms) for both NGX-4010 and a control patch containing a low concentration of the same active ingredient as NGX- 4010. When looking at the individual treatment arms, the 30-minute group treated with NGX-4010 achieved a 26.1% reduction in pain from baseline compared to 19.1% for the control group (p=0.1) and the 60-minute group treated with NGX-4010 achieved a 32.8% reduction in pain from baseline compared to 30.1% for the control group (p=0.5). Secondary endpoints also did not achieve statistical significance. Anthony DiTonno, Chief Executive Officer, commented, "We remain focused on our overall goal of achieving commercial launch of NGX-4010 in 2009. We are on track to file a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) later this year in postherpetic neuralgia (PHN), and are continuing with the Marketing Authorization Application (MAA) under the centralized procedure in the Europe Union where our application for approval was accepted by the European Medicines Agency (EMEA) in September of last year. We expect to consult with both regulatory agencies in the coming weeks to discuss how the results of this most recently completed trial, when taken in the context of the entire clinical development record of NGX-4010, which has been studied in over 1,600 patients, may support gaining an approval broader than the potential PHN indication. " NGX-4010 is a dermal patch containing capsaicin, a selective TRPV1 agonist, designed to manage peripheral neuropathic pain. The Company has previously completed three Phase 3 studies in PHN, of which two met their primary endpoint. In those studies, a single, 60-minute treatment with NGX- 4010 applied directly to the site of pain reduced pain for up to 12 weeks. In addition to being studied in PHN, NGX-4010 was also studied in a successful Phase 3 clinical trial in painful HIV-DSP.
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