A Multicenter Randomized, Double-Blind, Controlled Study to Evaluate Safety, Tolerability and Preliminary Efficacy of Two Capsaicin Concentration Variations of NGX-1998 (10% or 20% w/w) in Subjects With Postherpetic Neuralgia (PHN)

The purpose of this study is to assess the efficacy, safety and tolerability of NGX-1998 applied for 5 minutes for the treatment of postherpetic neuralgia (PHN).

开始日期2010-10-01

申办/合作机构

NeurogesX, Inc.

NCT00916942 / Completed临床2期

An Open-Label Study Of The Use Of Topical Lidocaine (2.5%)/Prilocaine (2.5%) Cream As Pre-Treatment For NGX-4010 In Subjects With Postherpetic Neuralgia (PHN)

This study is an open-label multi-center to evaluate the tolerability of treatment with NGX-4010 use with pre-patch topical application of a topical anesthetic cream. This is an open-label study. No hypothesis testing will be performed.
Eligible subjects will have PHN and a level of pain at an intensity level deemed appropriate for open-label treatment with NGX-4010, as judged by the Investigator. Painful areas of up to a maximum of 1000 cm2 will be pre-treated with lidocaine (2.5%)/prilocaine (2.5%) cream for 60 minutes followed by a single, 60-minute application of NGX-4010. Subjects may be on chronic pain medication regimens, but currently will not be using any topical pain medications on the affected areas, such as non-steroidal anti-inflammatory drugs, menthol, methyl salicylate, local anesthetics including Lidoderm® (lidocaine patch 5%), steroids or capsaicin.

开始日期2009-06-01

申办/合作机构

NeurogesX, Inc.

NCT00912262 / Completed临床1期

A Randomized, Single Blind Study to Investigate the Tolerability and Effects on Epidermal Nerve Fiber Density of Multiple Low-Concentrations of Capsaicin Topical Liquid NGX-1998 in Healthy Volunteers

The purpose of this single-blinded study in healthy volunteers is to select a Low-Concentration Capsaicin Topical Liquid (LC-CTL) to serve as a control formulation in the further clinical development of Capsaicin Topical Liquid, NGX-1998 (10% w/w). The goal is to identify a low concentration formulation that will not reduce ENFD in healthy normal volunteers when compared to NGX-1998 (10% w/w) but would still produce some local capsaicin-related application site responses (e.g. erythema, heat sensation or pain) when applied.

开始日期2008-06-01

申办/合作机构

NeurogesX, Inc.

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项与 NeurogesX, Inc. 相关的文献（医药）

2022-06-01·Pain

Benefit–risk assessment and reporting in clinical trials of chronic pain treatments: IMMPACT recommendations

Review

作者: Dworkin, Robert H. ; Steigerwald, Ilona ; Goli, Veeraindar ; Tobias, Jeffrey ; Markman, John D. ; Jensen, Mark P. ; Garrison, Louis P. ; Turk, Dennis C. ; O'Connor, Alec B. ; Singh, Jasvinder A. ; Mease, Philip J. ; Gewandter, Jennifer S. ; Lissin, Dmitri ; Cowan, Penney ; Farrar, John T. ; Kopecky, Ernest A. ; Jadad, Alejandro R. ; Strand, Vibeke ; Evans, Scott R. ; Raja, Srinivasa N. ; Kleykamp, Bethea A. ; Wasan, Ajay D. ; McDermott, Michael P. ; Iyengar, Smriti ; Sampaio, Cristina ; Ellenberg, Susan S. ; Tive, Leslie A. ; Junor, Roderick ; Wilson, Hilary D. ; Rowbotham, Michael C. ; Patel, Kushang V. ; Kesslak, J. Patrick ; Bhagwagar, Zubin ; Freeman, Roy L. ; Katz, Nathaniel P. ; Eccleston, Christopher

Abstract:

Chronic pain clinical trials have historically assessed benefit and risk outcomes separately. However, a growing body of research suggests that a composite metric that accounts for benefit and risk in relation to each other can provide valuable insights into the effects of different treatments. Researchers and regulators have developed a variety of benefit–risk composite metrics, although the extent to which these methods apply to randomized clinical trials (RCTs) of chronic pain has not been evaluated in the published literature. This article was motivated by an Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials consensus meeting and is based on the expert opinion of those who attended. In addition, a review of the benefit–risk assessment tools used in published chronic pain RCTs or highlighted by key professional organizations (ie, Cochrane, European Medicines Agency, Outcome Measures in Rheumatology, and U.S. Food and Drug Administration) was completed. Overall, the review found that benefit–risk metrics are not commonly used in RCTs of chronic pain despite the availability of published methods. A primary recommendation is that composite metrics of benefit–risk should be combined at the level of the individual patient, when possible, in addition to the benefit–risk assessment at the treatment group level. Both levels of analysis (individual and group) can provide valuable insights into the relationship between benefits and risks associated with specific treatments across different patient subpopulations. The systematic assessment of benefit–risk in clinical trials has the potential to enhance the clinical meaningfulness of RCT results.

2014-02-01·The Clinical journal of pain3区 · 医学

NGX-4010, a Capsaicin 8% Dermal Patch, for the Treatment of Painful HIV-associated Distal Sensory Polyneuropathy

3区 · 医学

Article

作者: Michael Rubin ; Jose Castro ; Corklin Teinhart ; Geertrui F. Vanhove ; George Drusano ; Ronald Ellis ; Justin McArthur ; Harold Artin ; Cynthia Brinson ; Stephen Brown ; Gerald Pierone ; Victor Valcour ; Joe Berger ; David M. Simpson ; Ann Morris ; Claire Borkert ; Russell Bartt ; Edwin De Jesus ; Barry Cutler ; Dean Rider ; David Clifford ; Grace McComsey ; David Brand ; Jeffrey K. Tobias ; Robert Myers ; Alex Tselis ; Amy Colson ; Leslie Diaz ; Colin Hall ; James Sampson ; Mollen Martin ; Suzanne Gazda ; Yuen So

OBJECTIVES:

To evaluate the efficacy, safety, and tolerability of repeated NGX-4010 treatments in the open-label extension phase of a 52-week study in patients with neuropathic pain due to HIV-associated distal sensory polyneuropathy (HIV-DSP).

METHODS:

Patients completing the 12-week, randomized, double-blind phase of the study could enter a 40-week, open-label phase, and receive up to 3, 60-minute NGX-4010 treatments. Patients recorded their "average pain for the past 24 hours" daily using the Numeric Pain Rating Scale (NPRS). Efficacy assessment included the percentage NPRS score reduction from baseline to weeks 2 to 12 after the final treatment, and Patient Global Impression of Change (PGIC) and Clinician Global Impression of Change (CGIC) questionnaires at study termination.

RESULTS:

Of 307 patients randomized, 272 entered the open-label phase; 81, 90, 55, and 46 received 0, 1, 2, and 3 retreatments, respectively. The mean percentage decrease in NPRS score from baseline to weeks 2 to 12 after the final treatment was similar in patients receiving single or multiple NGX-4010 treatments (-25.8%, -27.1%, -24.6%, and -22.7% for 1, 2, 3, and 4 NGX-4010 treatments, respectively). PGIC and CGIC results demonstrated a benefit of NGX-4010 treatment through to the end of the study regardless of the number of treatments received. Transient local application site reactions were the most frequently reported adverse events, and were mainly mild to moderate, nonserious, and did not increase with repeated treatment.

DISCUSSION:

Repeated NGX-4010 treatments were generally well tolerated and resulted in consistent reductions in HIV-DSP-associated pain and improvement in patient-reported outcomes.

2012-08-01·Toxicologic pathology4区 · 医学

A Comprehensive Review of the Carcinogenic and Anticarcinogenic Potential of Capsaicin

4区 · 医学

Review

作者: Bley, Keith ; Babbar, Sunita ; Boorman, Gary ; McKenzie, Donald ; Mohammad, Bashir

Human exposure to capsaicin, the most abundant pungent chili pepper component, is ubiquitous. Evaluation of capsaicin’s carcinogenic potential has produced variable results in in vitro and in vivo genotoxicity and carcinogenicity assays. The capsaicin tested in older studies was often from pepper plant extracts and included other capsaicinoids and diverse impurities. Recent studies utilizing high-purity capsaicin and standardized protocols provide evidence that the genotoxic and carcinogenic potential of capsaicin is quite low and that the purity of capsaicin is important. Several small epidemiological studies suggest a link between capsaicin consumption and stomach or gall bladder cancer, but contamination of capsaicin-containing foods with known carcinogens renders their interpretation problematic. The postulated ability of capsaicin metabolites to damage DNA and promote carcinogenesis remains unsupported. Anticancer activities of capsaicin have been widely reported, as it inhibits the activity of carcinogens and induces apoptosis in numerous cancer cell lines in vitro and explanted into rodents. Diverse mechanisms have been postulated for capsaicin’s anticancer properties. One hypothesis is that inhibition of cytochrome P450 enzymes—particularly CYP2E1—retards carcinogen activation but is contradicted by the low potency of capsaicin for CYP inhibition. The potential for dietary capsaicin to act as a chemopreventative is now widely postulated.

项与 NeurogesX, Inc. 相关的新闻（医药）

2023-03-23

·FierceBiotech

Disgraced former Seagen CEO tapped to lead MorphImmune less than a year after domestic assault arrest

Prosecutors declined to charge former Seagen CEO Clay Siegall in December 2022 after he was arrested for domestic violence earlier in the year. Former Seagen CEO Clay Siegall, Ph.D., will head up a new biotech spun out of Purdue University, less than a year after he stood down from the Seattle-based biopharma in the wake of an arrest for alleged domestic violence. Siegall, best known for co-founding and building Seagen into an oncology powerhouse that was recently bought by Pfizer for $43 billion, resigned in May 2022 following the arrest. A memo obtained by The Seattle Times detailed prosecutors' reasoning for declining to charge Siegall, which centered on contradictory witness statements. MorphImmune noted this decision in its statement. The preclinical oncology company also said in a statement to Fierce Biotech that it is a “values-based company” that prioritizes ethics, integrity and respect for others. The biotech said that its own outside counsel, as well as executive search agency Caldwell, performed an independent review on Siegall before the hire. MorphImmune’s board also “performed its own due diligence.” “These assessments find that Dr. Siegall is uniformly recognized not only as a highly passionate and dedicated person who has a demonstrated ability to build significant value as a company leader\ but also a colleague whose workplace demeanor and values are entirely consistent with those of MorphImmune,” the biotech said. Ronald Martell, former CEO of Sevion and NeurogesX, previously led MorphImmune after being hired almost two years ago. The company was spun out of research from Philip Low, a distinguished professor of chemistry at Purdue University. Low was co-founder and chief scientific officer at Endocyte, an Indiana-based biotech that was bought by Novartis in 2018 for $2.1 billion. MorphImmune’s chief scientific officer, Jack Higgins, was previously the chief development sciences officer at Molecular Templates. MorphImmune describes itself as designing targeted drugs that can “reprogram specific immune cell types” to treat a bevy of diseases. The company is currently advancing a couple of candidates including a folate receptor-targeted TLR7 agonist and a fibroblast activation protein (FAP) targeted radioligand therapy. MorphImmune has received early seed and follow-on investments from Research Bridge Partners, although it hasn't disclosed how much money has been raised to date. Editor's note: This story was updated with information about MorphImmune's pipeline.

并购高管变更

2012-09-05

·BioSpace

NeurogesX, Inc. to Present at Rodman & Renshaw 14th Annual Healthcare Conference

SAN MATEO, Calif., Sept. 5, 2012 (GLOBE NEWSWIRE) -- NeurogesX, Inc. (OTCQB:NGSX) (OTCBB:NGSX), a specialty pharmaceutical company focused on developing and commercializing a portfolio of novel non-opioid, pain management therapies, announced today that Ronald Martell, President and Chief Executive Officer, is scheduled to present at the Rodman & Renshaw 14th Annual Healthcare Conference to be held September 9-11, 2012, at the Waldorf Astoria Hotel in New York, NY. Mr. Martell, as well as Stephen Ghiglieri, Chief Financial Officer, will be available to respond to questions and participate in one-on-one meetings with investors.

2010-09-07

·BioSpace

NeurogesX, Inc. to Present at Three Upcoming Conferences

SAN MATEO, Calif., Sept. 7 /PRNewswire/ -- NeurogesX, Inc. (Nasdaq: NGSX), a biopharmaceutical company focused on developing and commercializing novel pain management therapies, announced today that Anthony DiTonno, President and Chief Executive Officer, is scheduled to present at three upcoming conferences: the Rodman & Renshaw Global Investment Conference, to be held September 13-15, 2010 in New York, NY; the UBS Global Life Sciences Conference, taking place September 20-22, 2010 in New York, New York; and the JMP Securities Healthcare Conference, taking place September 27-28, 2010 in New York, NY. Mr. DiTonno and Stephen Ghiglieri, Executive Vice President, Chief Operating Officer and Chief Financial Officer, will be available to respond to questions immediately following the presentations and to participate in one-on-one meetings with investors attending the conferences. Event: Rodman & Renshaw Annual Global Investment Conference Date: Tuesday, September 14, 2010 Time: 9:15am ET Place: New York Palace Hotel, New York, NY Event: UBS Global Life Sciences Conference Date: Monday, September 20, 2010 Time: 4:00pm ET Place: The Grand Hyatt, New York, NY Event: JMP Securities Healthcare Conference Date: Tuesday, September 28, 2010 Time: 1:00pm ET Place: New York Palace Hotel, New York, NY All presentations will be webcast live and can be accessed by visiting the investor relations section of NeurogesX' website at . The webcast will be archived for 90 days. About NeurogesX, Inc. NeurogesX, Inc. (Nasdaq: NGSX) is a San Francisco Bay Area-based biopharmaceutical company focused on developing and commercializing novel pain management therapies. NeurogesX was founded on the concept that use of prescription-strength capsaicin could help manage the pain associated with neuropathic pain conditions. Since its inception, NeurogesX has leveraged its passion to help people with pain to efficiently develop this concept, resulting in the commercial launch of Qutenza® (capsaicin) 8% patch in 2010. The Company continues to apply its knowledge and expertise in the development of other novel treatments for pain. The Company's lead product, Qutenza, is a localized dermal delivery system containing prescription strength capsaicin that is currently approved in the United States and the European Union. Qutenza is now available in the United States for the management of neuropathic pain associated with postherpetic neuralgia (PHN). In Europe, Qutenza is being marketed by Astellas Pharma Europe Ltd. (Astellas), the European subsidiary of Tokyo-based Astellas Pharma Inc. The Company's most advanced product candidate, NGX-1998, is a topically applied liquid formulation containing a high concentration of capsaicin designed to treat pain associated with neuropathic pain conditions such as PHN. NGX-1998 has completed three Phase 1 studies. The Company's early-stage product pipeline includes pre-clinical compounds which are prodrugs of acetaminophen and various opioids. The Company has evaluated these compounds in vitro and in vivo. 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 about the safety and efficacy of Qutenza. 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: difficulties or delays in the commercialization of Qutenza, including with respect to manufacture and supply of Qutenza; Qutenza and NeurogesX' other product candidates may have unexpected adverse side effects; physician or patient reluctance to use Qutenza; and other difficulties or delays in the launch of Qutenza in the United States and, by Astellas in the European Union. For further information regarding these and other risks related to NeurogesX' business, investors should consult NeurogesX' filings with the Securities and Exchange Commission. NeurogesX, Inc. The Ruth Group Stephen Ghiglieri Sara Pellegrino (investors) Executive Vice President, COO and CFO (646) 536-7002 (650) 358-3310 spellegrino@theruthgroup.com Jason Rando (media) (646) 536-7025 jrando@theruthgroup.com SOURCE NeurogesX, Inc.

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