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NeurogesX Announces Preliminary Results from Second Phase 3 Clinical Trial in HIV-DSP
Date:2/27/2008

Primary and Secondary Endpoints Do Not Achieve Statistical Significance

Company Affirms Plans to File NGX-4010 NDA in 2008

Schedules Investor Conference Call at 5:00 p.m. EST

SAN MATEO, Calif., Feb. 27 /PRNewswire-FirstCall/ -- NeurogesX, Inc. (Nasdaq: NGSX), a biopharmaceutical company focused on developing and commercializing novel pain management therapies, today 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 oth
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SOURCE NeurogesX, Inc.
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