SAN CARLOS, Calif., June 11 /PRNewswire-FirstCall/ -- 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
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
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.
NeurogesX | Stephen Ghiglieri | (650) 508-2116
The Ruth Group
Investors/Media | Stephanie Carrington/Jason Rando | (646) 536-7017 / 7025 | email@example.com | firstname.lastname@example.org
SOURCE NeurogesX, Inc.