Press Release
NeurogesX Launches Multi-Center Study for Painful HIV-Associated Neuropathy
Large Clinical Trial Follows Promising Results of Pilot StudySan Carlos, Calif. - October 8, 2003
NeurogesX, Inc. announced today the initiation of a Phase II/III clinical study of NGX-4010 for the treatment of neuropathic pain associated with HIV infection and AIDS.
Neuropathic pain is often the most disturbing manifestation of distal symmetrical polyneuropathy, which is estimated to occur in up to one-third of HIV-infected individuals with longstanding HIV infection and AIDS. Severe pain, mostly in the feet, often results and is historically difficult to treat. No FDA-approved therapy is available to date.
NGX-4010 is a novel high-concentration capsaicin dermal delivery system, which is being studied in various neuropathic pain conditions.
A significant and substantial pain reduction lasting four weeks after a single application of NGX-4010 was shown in a randomized controlled study in postherpetic neuralgia (PHN), a painful condition that may persist following an outbreak of herpes zoster, commonly known as shingles. Subsequently, substantial reductions in pain were observed in a 12-week open-label study in painful HIV-associated neuropathy.
"This preliminary study demonstrates the tolerability of NGX-4010 in patients with HIV-related neuropathic pain," said Dr. David Simpson, Professor of Neurology, Mount Sinai School of Medicine, and a principal investigator for the pilot study. "The very promising treatment results warrant further evaluation of safety and efficacy in the setting of a larger, controlled trial." Dr. Simpson is serving as the lead academic investigator for the new Phase II/III trial.
Details of the Multi-Center Phase II-III Study
The study is a randomized, double-blind, controlled trial to compare the analgesic effect of NGX-4010 compared to a control treatment (low-concentration capsaicin) given for 30, 60 or 90 minutes. The trial will enroll up to 300 patients with moderate to severe pain from HIV-associated neuropathy at 30 sites across the United States. Enrollment is ongoing and expected to continue into early 2004. Patients will be followed for 12 months, with the option of receiving additional open-label treatment up to three times based on the persistence or recurrence of HIV neuropathy pain. The primary endpoint in this study is analgesic efficacy as measured using standard patient-completed daily pain diaries. Other endpoints include safety and tolerability, as well as additional efficacy measures such as onset and duration of analgesic effects.
"Study C107 will allow us to assess the efficacy, safety and tolerability of NGX-4010 at three different dose levels for treating painful symptoms of HIV-associated neuropathy, whether resulting directly from HIV disease or from certain antiretroviral drugs," said Thorsten von Stein, MD, PhD, Chief Medical Officer of NeurogesX. "The study will also yield information about the efficacy, safety and tolerability of open-label re-treatment with NGX-4010 over one year."
For further information about ongoing clinical trials in painful HIV-associated neuropathy and PHN, please visit ClinicalTrials.gov and search by "NeurogesX" (no quotes). ClinicalTrials.gov, a service of the U.S. National Library of Medicine (NLM), 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 privately held specialty pharmaceutical company focusing on the development of products for the treatment of nerve signaling disorders. The company’s initial products are focused on the treatment of chronic and acute pain. The company is also applying its basic science and clinical expertise in neurobiology to develop treatments for non-pain indications caused by aberrant nerve signaling. The company 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, Grove Street Advisors for CalPERS, TIAA (Teachers Insurance and Annuity Association), Duke University, Montreux Equity Partners, 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:
Anthony A. DiTonno
CEO and President
NeurogesX, Inc.
aditonno@neurogesx.com
650-508-2116
Stephen F. Ghiglieri
CFO
NeurogesX, Inc.
sghiglieri@neurogesx.com
650-508-2116
Mike Jackman
Jackman Communications
mike@jackman.com
415-388-3216