Nicotine abuse vaccine TA-NIC(ImmuLogic Pharmaceutical)(Nicotine abuse vaccine TA-NIC(ImmuLogic Pharmaceutical))

概要

基本信息

药物类型

疫苗

别名

TANIC

靶点-

作用机制

免疫刺激剂

治疗领域

其他疾病

在研适应症-

非在研适应症

戒烟

原研机构

ImmuLogic Pharmaceutical Corp.

在研机构-

非在研机构

Celtic Pharma Capital Ltd.

最高研发阶段无进展临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

2

项与 Nicotine abuse vaccine TA-NIC(ImmuLogic Pharmaceutical) 相关的临床试验

NCT00633321 / Completed临床2期

A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Multicenter, Dose-Ranging Study of 100 or 250 μg of TA-NIC to Assess the Efficacy and Safety of the Vaccine as an Aid to Smoking Cessation

Over 1 billion people worldwide smoke, resulting in an estimated 4 million deaths annually from smoking-related disease.1 Persistent and long-term smoking leads to an increased risk of cardiovascular damage, respiratory disease, and a higher incidence of a variety of cancers; but for smokers who can quit there is an immediate and significant beneficial impact on their health and life expectancy. Cigarette smoking remains the leading preventable cause of death in the United States (US), accounting for approximately 1 of every 5 deaths (438,000 people) each year.
This Phase 2 study will investigate the efficacy and tolerability of 2 doses of TA-NIC compared to placebo as an aid to smoking cessation in smokers who are motivated to quit.

开始日期2007-05-01

申办/合作机构

Celtic Pharma Development Services, Inc.

EUCTR2005-000922-22-GB / Unknown statusN/A

A phase II double blind, randomised, placebo controlled, multicentre study to assess the efficacy and safety of TA-NIC in maintaining smoking cessation when given in conjunction with Nicotine Replacement Therapy (NRT) - Maintenance of smoking cessation in smokers who have quit (TA-NIC/03)

开始日期2006-04-18

申办/合作机构

Xenova Ltd.

100 项与 Nicotine abuse vaccine TA-NIC(ImmuLogic Pharmaceutical) 相关的临床结果

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100 项与 Nicotine abuse vaccine TA-NIC(ImmuLogic Pharmaceutical) 相关的转化医学

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100 项与 Nicotine abuse vaccine TA-NIC(ImmuLogic Pharmaceutical) 相关的专利（医药）

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8

项与 Nicotine abuse vaccine TA-NIC(ImmuLogic Pharmaceutical) 相关的文献（医药）

2020-01-01·Enfermería Clínica

Validación y aplicación de un instrumento para la documentación del proceso enfermero en cuidados intensivos

Article

作者: Aurélio-Boes, Marcos ; de Souza Oliveira-Kumakura, Ana Railka ; Trevisan, Danilo Donizetti ; Wopereis-Groot, Margareta Maria ; Nazário-Aoki, Roberta

OBJECTIVEto validate the content of an instrument for documenting the steps of the Nursing Process, using the standardized languages NANDA-I, NOC, and NIC (NNN), aiming at hospitalized patients in an Intensive Care Unit (ICU).METHODA methodological research performed in three steps: design of the existing instrument from the systems NANDA-I, NOC and NIC; content validation by 13 judges, from a four-point Likert-type scale - items were evaluated as to their clarity and pertinence; applicability: judgement of the content regarding clarity, reading ease, and presentation for 40 critical-care nurses. The Content Validity Index (CVI) and the Kappa coefficient (k) was calculated to measure the proportion of relevance and clarity, was well as to verify the level of agreement between the experts in each item.RESULTSThe instrument was considered clear and pertinent, with CVI above 0.8 in most items and overall Concordance Index (CI) of 0.90, showing a satisfactory level of agreement between judges. Regarding applicability, the instrument was deliberated clear, of easy reading, and with proper presentation by most critical-care nurses, being validated through 11 diagnoses with their respective results and nursing interventions.CONCLUSIONThe instrument showed to be valid and applicable for the group studied. It is expected that this study is able to contribute to the improvement of the Nursing Process in intensive care.

2008-12-02·Annals of Internal Medicine

Is Long-Term Use of Antismoking Drugs Consistent with Public Health Goals or Pharmaceutical Marketing Goals?

Letter

作者: Fugh-Berman, Adriane J ; Melnick, Douglas

TO THE EDITOR: A recent article by Steinberg and colleagues (1) argues that tobacco dependence should be considered a medical disease, like asthma or diabetes. Steinberg and colleagues argue that the smoking habit deserves chronic disease status, and that long-term drug treatment, despite being an off-label use, should be reimbursed. Smokers should be encouraged and supported to quit smoking, with short-term pharmacologic aids if necessary. Long-term use of products that have not been tested or approved for long-term use, however, is inconsistent with public health goals while being consistent with pharmaceutical marketing goals. We note that 2 authors of the commentary are on the speaker’s bureau of Pfizer and are consultants to Pfizer, Novartis, GlaxoSmithKline, and Celtic Pharma. Pfizer makes Chantix (varenecline) and Nicotrol nasal spray. GlaxoSmithKline makes Nicorette gum, Commit nicotine lozenges, Nicoderm nicotine patches, and Zyban (bupropion, also sold as Wellbutrin). Novartis makes Thrive, a nicotine chewing gum. Celtic Pharma is developing TA-NIC, a nicotine vaccine. Perhaps smoking cessation aids are being repositioned as longterm maintenance medications in order to expand the market. We think it a shame that Annals provided legitimacy to that goal by publishing the recent article.

2006-01-01·Przeglad lekarski

[New prospects of nicotine dependence treatment--vaccines].

Review

作者: Zymełka, Anna ; Koszowski, Bartosz ; Czogała, Jan ; Goniewicz, Maciej Lukasz

Smoking is considered to be one of the main threats to health in many societies around the world. Despite carrying out numerous large-scale campaigns promoting a healthy life-style and stimulant avoidance, nicotine dependence still concerns a huge group of people. What is more, almost half of the population is exposed to passive contact with tobacco smoke. At present, there is a whole range of pharmaceutical and non-pharmaceutical means of fighting nicotine dependence. The dramatic development of medical sciences in recent years, especially of the fields connected with biotechnology, resulted in working out of a new method of nicotinism treatment--antinicotinic vaccines. The starting point for working out of such drugs was the mechanism of nicotine action on central nervous system. The idea behind the vaccine is to prevent nicotine from passing through the blood-brain barrier. Nicotine molecules, due to their size and lipophilic character, can easily enter the brain. The mechanism of the antinicotinic vaccine's action consists in producing specific antibodies, which combined with nicotine in the bloodstream are to create immune complexes big enough not to enter the brain. Currently, clinical trails of three vaccines are being carried out: TA-NIC (Xenova Group, UK), NicVAX (NABI Biopharmaceuticals, USA), CYT002-NicQb (Cytos Biotechnology, Switzerland). The results indicate that this form of treatment is interesting when it comes to its effectiveness and in the future may become a routine method of nicotine dependence treatment.

100 项与 Nicotine abuse vaccine TA-NIC(ImmuLogic Pharmaceutical) 相关的药物交易

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