Press Release
Significant Pain Reduction for Painful HIV-Associated Neuropathy Demonstrated in NeurogesX Pilot Study
Substantial Pain Decreases From a Single 1-Hour Topical Treatment Sustained for 12 WeeksSan Carlos, Calif. - February 9, 2004
NeurogesX, Inc. announced today results from an open-label, multi-center study evaluating NGX-4010, a novel high-concentration trans-capsaicin dermal delivery system in patients with painful HIV-associated neuropathy. The study showed a mean decrease in pain intensity of 40 percent that remained stable for 12 weeks from a single, one-hour application. The results of the clinical trial were presented today at the 11th Conference on Retroviruses and Opportunistic Infections in San Francisco by Dr. David Simpson, Professor of Neurology, Mount Sinai School of Medicine, and a principal investigator for the study.
HIV infection itself and certain antiretroviral medications are both associated with the development of neuropathic pain, which is estimated to occur in up to one-third of HIV-infected individuals with longstanding HIV infection and AIDS. Symptoms range from mild tingling to severe and excruciating pain, mostly in the feet, in response to normal daily stimuli such as putting on socks. This condition is difficult to treat and there is no FDA approved therapy available to date.
The open-label, multi-center study evaluated the efficacy, safety and tolerability of NGX-4010 in twelve patients in 3 centers who were treated once and followed for 12 weeks. Patients recorded their pain intensity daily on an 11-point numerical scale. The primary efficacy endpoint was “percent change from baseline” in the “average pain for the past 24 hours” numerical pain score. Two-thirds of patients experienced pain decreases of 30 percent or more. Overall, tolerability was good with 100 percent of patients able to complete the treatment. No significant safety issues were noted. Importantly, further pain relief was seen even in patients already using other neuropathic pain treatment regimens, including opioids and anticonvulsant medications.
“These results are very encouraging,” said Dr David Simpson. “We are looking forward to confirming these results in the large, controlled clinical trial that is currently enrolling. If these results are confirmed, this could be the first effective tool for neuropathic pain associated with HIV infection and AIDS.” Dr Simpson is serving as the lead investigator for the new phase II/III randomized, double blind, controlled trial which is currently enrolling in 30 investigator sites across the United States.
NeurogesX’s current trial will enroll 300 patients with moderate to severe pain from HIV-associated neuropathy. Enrollment is ongoing and expected to continue through spring of this year. Patients will be followed for 12 months with the opportunity to receive additional open-label treatment up to three times, based on persistence or recurrence of neuropathic pain.
“The data presented today are validating for the continued development of NGX-4010, which has shown similar results in Phase II studies in patients suffering from post-herpetic neuralgia. Perhaps more importantly, these data are promising in the continuing search of clinically meaningful, peripherally focused solutions to the debilitating effects of neuropathic pain,” said Dr. Thorsten von Stein, Chief Medical Officer of NeurogesX, Inc. “Our HIV development program is a key part of our overall development program of NGX-4010.”
For further information about ongoing clinical trials in painful HIV-associated neuropathy and participating clinical sites, please visit ClinicalTrials.gov and search by “NeurogesX”. ClinicalTrials.gov , a service of the U.S. National Library of Medicine (LMN), provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.
About NeurogesX
NeurogesX (neur-o-GEE-six) is a late-stage, venture-financed, specialty pharmaceutical company developing novel treatments for neuropathic pain through advanced neuroscience insights and innovative delivery technology. The company’s first product, a topical treatment for neuropathic pain, has been evaluated in Phase II trials for the treatment of pains associated with shingles and HIV neuropathy-associated pain. Three Phase III multi-center pivotal clinical trials focused on these indications are currently enrolling patients. The company is also planning trials in painful diabetic neuropathy which will start in the second half of 2004. NeurogesX has raised $30 million in total equity investments since its first funding round in June 2000. Investors include Alta Partners, ARCH Venture Partners, Montreux Equity Partners, TIAA (Teachers Insurance and Annuity Association), Duke University, University of North Carolina and Walden International.
For more information about NeurogesX, go to www.neurogesx.com.
NeurogesX is a trademark of NeurogesX, Inc. All other trademarks and registered trademarks are those of their respective companies
Contacts:
Thorsten von Stein, Chief Medical Officer
CEO and President
NeurogesX, Inc.
tvonstein@neurogesx.com
650-508-2116
Mike Jackman
Jackman Communications
mike@jackman.com
415-388-3216