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Monday, July 16, 2012

Abstract

Cytisine (Tabex) has been licensed in Eastern Europe as an aid to smoking cessation for 40 years. Cytisine is a partial agonist with high affinity binding to the α4β2 nicotinic acetylcholine receptor believed to be central to the rewarding effect of nicotine. There is insufficient information on effectiveness to warrant licensing by modern standards. To assess whether full‐scale controlled trials are warranted, this study sought to obtain an estimate of the 12‐month continuous abstinence rates of smokers using cytisine with minimal behavioural support.



Sunday, July 8, 2012

CLINICAL STUDIES


EEXTAB declared that the fundamental TASC trial (“TAbex® Smoking Cessation”)achieved all objectives with statistically significant levels of smoking cessation by the end of the first year


Convincing relative share of the smokers that gave up cigarettes by the end of the first year with odds ratio 3,7 (р<0.001)
Efficacy (compared to placebo), comparable with the most prescribed smoking cessation devices.
Results published in New England Journal of Medicine.
Treatment with optimum price/efficiency ratio and with a potential for global contribution in the fight against smoking.
Favourable safety profile without neurological and psychiatric problems.


Wilmington, Delaware & London, 29-th September 2011 –EXTAB („Extab”) corporation, a biopharmaceutical company for products in clinical phase, focused on the fight against smoking, has announced today positive, statistically significant results from the fundamental TASC trial on Tabex®. The trial was double-blind, placebo-controlled and included 740 smokers. The main and all secondary objectives were achieved.

The main objective of the trial was based on Russell Standard criteria for a 12-month abstinence from smoking after treatment completion. Cigarette quitting was objectively confirmed by measurement of carbon dioxide content in the air exhaled by the participants. The 12-month relative share of the Tabex-treated participants who gave up smoking was 8,4%, while in the placebo group it was 2,4 % (р<0.001). The odds ratio was 3.7 meaning that Tabex-treated smokers' chance to give up smoking was 3,7 times higher than that of the placebo group.

TASC trial was conducted in Poland on 740 addicted smokers. The psychological support and the number of monitoring sessions was brought to a minimum to simulate as far as possible a typical clinical environment. The treatment course was 25 days according to the current officially approved Tabex dosage.


TASC trial was financed by the National Preventive Research Institute (NPRI) with the support of the British Heart Foundation and the Department of Health and Cancer Research of the United Kingdom. Chief Investigator was Robert West (Professor in Health Psychology, London University College). The trial was conducted in Poland under the direction of Witold Zatonski (Professor in Epidemiology at Maria Sklodowska Curie Memorial Cancer Centre in Warsaw)

The results from the clinical trial have been published on-line on 29 September 2011 inNew England Journal of Medicine - http://www.nejm.org/doi/full/10.1056/NEJMoa110203.

Rick Stewart, Chairman and Chief Executive Officer of Extab sais: „We are delighted with these very good results. They confirm the data from previous clinical studies and from the experience gathered with Tabex in clinical practice. The efficacy demonstrated in the TASC trial can be positively compared with present-day most frequently prescribed therapies for smoking cessation. Efficacy could be further enhanced by addition of psychological support in future clinical trials. Detailed analysis of Tabex safety data did not reveal any significant neuropsychiatric or behavioral adverse reactions. We believe that this new evidence will speed up Tabex registration.”

Professor Robert West from the Department of Epidemiology at London University College, Chief Investigatory of the trial, sais:

„There are over a billion smokers in the world , and lung cancer is still among the leading causes of death. On this background, we are extremely encouraged by the fact that Tabex benefits are comparable with those of the best-selling smoking cessation devices, but the cost is significantly lower. We know that smoking cessation can be extremely difficult and, as shown by the results of this trial, we hope that the use of cytisine as nicotine substitute will help for improvement of social health worldwide by ensuring a real opportunity even for the poorest smokers.”

Jean King, Tobacco Control Adviser with the Institute for Cancer Research in the United Kingdom, sais:”It is a wonderful news that smokers worldwide will have an access to a new medicine for fighting their addiction. It is an absurd that cigarette companies are still permitted to advertise their deadly products and attract young people on the background of so many smokers who desperately try to give up cigarettes. We hope that cytisine will help the countries with low and medium living standards to perform their engagements in the fight against nicotine dependence in conformity with the Anti-tobacco Agreement of WHO”

Tabex has been marketed by Sopharma AD for many years in Central and Eastern Europe as a comparatively safe and efficient device for smoking cessation. Over 20 million patients have been treated up till now, and the last Periodic Safety Update Report analyses and summarizes the data of 4 mln. patients. Many clinical trials that included over 7000 participants have demonstrated Tabex efficacy and safety up till now. TASC is the first large trial conducted according to the rules of Good Clinical Practice (GCP).Adverse drug reactions related to Tabex administration have been mild and limited in general, with an excellent benefit/risk ratio.

EXTAB holds the rights of Tabex worldwide (except for the existing markets of SOPHARMA AD) and develops patent-protected forms of Tabex for the large markets in the developed countries as the USA, EU and Japan. Partnership activities are underway in China, India and the other developing markets.

Dr.Antony Clerk (Scientific Director) sais: “There is an urgent need of alternative efficient and affordable products on medical prescription for smoking cessation. Assessments of the World Health Organization (WHO) reveal that the present number of smokers is 1,3billion worldwide and the smoking-related death rate is over 5 mln. persons annually.WHO forecast is of 1 billion death cases due to smoking-related diseases in this century.We believe that Tabex is a unique opportunity to provide the Western markets and the developing world with an efficient and affordable treatment.”
Tabex® has been studied in 8 multicenter clinical trials of various design in Germany, Bulgaria and Poland. Summarized results have shown:
Tabex® was administered orally to 1045 subjects, compared to 400 smokers, taking placebo and 1500 taking other anti-smoking products.
Clinical results showed high per cent of smoking cessation with Tabex® that was higher and statistically reliable compared to placebo and the other products.
The daily therapeutic dose of Tabex® was 1.5 to 9 mg daily with no occurrence of undesirable effects.
An improvement in the general condition of smokers after smoking cessation with the help of Tabex® was reported due to discontinuation of chronic nicotine intoxication.
Tabex® has very good tolerance and in therapeutic doses it does not cause anorexia, nausea and vomiting.


The long-year clinical studies have shown the advantages of Tabex® and its medicinal efficacy in different groups of smokers.


A high percent (over 55-76%) of the subjects treated with Tabex® gave up smoking
Good tolerance and lack of undesirable effects in therapeutic doses
Good effect on depressive conditions and chronic pulmonary diseases that accompany longterm smoking
No undesirable drug interactions with neuroleptics, anti-depressants and insulin were reported.





People who smoke so-called light cigarettes are half as likely to quit than other smokers, research suggests



A false perception of reduced health risks with low-tar and low-nicotine brands could be a factor, the US authors believe. A third of those smoking lights said they had chosen this type of cigarette to reduce their health risks. Yet by doing so they may be increasing their health risks, say the authors in the American Journal of Public Health. The study of more than 12,000 smokers revealed those who used light cigarettes were about 50% less likely to quit than other cigarette smokers.

"All cigarettes are deadly" - Amanda Sandford of Action on Smoking and Health

Misnomer

Although light cigarettes contain less tar and nicotine, they are still linked to smoking-related diseases such as cancer. People who smoke light cigarettes are likely to inhale the same amount of hazardous chemicals because they inhale deeper to get enough smoke for a satisfactory nicotine 'hit', according to the National Cancer Institute. Therefore, they remain at high risk for developing smoking-related cancers and other diseases. All cigarettes are deadly manda Sandford of Action on Smoking and Health The only way to reduce the health risks is to quit altogether, say health experts.

Most of the light smokers in the study were women. The University of Pittsburgh School of Medicine team say its findings apply to some 30 million US adult smokers who smoke light cigarettes. Author Dr Hilary Tindle said: "Even though smokers may hope to reduce their health risks by smoking lights, the results suggest they are doing just the opposite because they are significantly reducing their chances of quitting. "Moreover, as they get older their chances of quitting become more and more diminished." She said it was vital smokers were given accurate information on associated health risks. European law bans misleading descriptions such as "light" and "mild" on all cigarettes sold in the European Union. In the US, however, no such laws exist. Amanda Sandford, of Action on Smoking and Health, said earlier research in the UK backed the US study's findings.

"It's not surprising that even though logically people know that all smoking is harmful, the power of marketing is such that many people would be conned into thinking the so-called lower tar or light brands are less dangerous. All cigarettes are deadly."








DOSAGE REGIMEN

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WHAT IS TABEX?

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