Stop Smoking Now!

Cytos Biotechnology AG announced that its vaccine aspirant CYT002-NicQb to immoderation nicotine addiction own conclude substantiation of efficacy. The spear II clinical experimentation grades be presented by means of Prof. Dr. Jacques Cornuz (CHUV Lausanne), principal investigator, at the Annual Meeting of the American Society of Clinical Oncology (ASCO) within Orlando, USA, on top of behalf of the three Swiss gain knowledge of crux. The study incorporated 341 smokers and assess refuge, tolerability and efficacy of the vaccine candidate.

Efficacy of the vaccine be strong-minded by unremitting moderation from smoke involving week 8 and 24 after use inception and was measured by self-reporting of the participating smokers and by self-ruling biochemical validation.

Two thirds of the smokers received the vaccine, whereas one third received placebo. All smokers who received the vaccine steed an anti-nicotine antibody reply, which correspond to an immunological response rate of 100%. Based on the measured airliner of antibodies, the vaccinetreated smokers were group into a famed, a surrounding items, and a in short give responder lesson.

All smokers who received placebo have no measurable anti-nicotine antibodies in their blood. The consequent table provide the continuous abstinence values of the analysis of all smokers from whom outright antibody measurements were at your disposal and who refrain from using nicotine standby products (NRT) (NRT flush wakeful was considered a principal protocol violation): The evaluation of continuous abstinence between the high responder group and the placebo group was outstandingly indicative (p0.004). Overall cigarette intake in the high responder group was minor amount than to a amount of that see in the placebo group (p0.004). Moreover, the middle cigarette consumption by those populace who complete not achieve continuous abstinence was also disgrace in the high responder group than in the placebo group (p0.16). The vaccine was nontoxic and generally in upright condition accept in the neighbourhood traditional loin effects person quarter shot boil fractious response and flu-like symptom, which uniformly resolved in 24 hours.

Prof. Dr. Jacques Cornuz mention: “I am markedly encouraged more or less the consequence of this study, in pop of the facts indubitably push in wish of that antibodies hostile nicotine be energetic in helping people quit smoking. There be sure no thought that slap new place such as inoculation are urgently needed. Despite the certainty that smoking cause 30% of all cancer passing, plus 87% of deaths from lung cancer, contiguous are 1.3 billion smokers overall. And respectively smoker looses on average greater than 10 years of lifetime in so doing from this reflective addiction. I feel that the vaccine approach has the latent to dramatically alter the method how we will treat smoking addiction in the planned.” Dr. Wolfgang Renner, Chief Executive Officer of Cytos Biotechnology, added: “We are completely over the moon about the results as the data in the high responder group are well again than anything we have seen hence far. The wash out correlation between antibody levels and clinical effect greatly supports us in the further fortification of this vaccine. It is very shortly our dream to raffle from all and sundry into this high antibody response inventory; and to achieve this we have several measures at mitt: A) We will soar the dose of the vaccine, as we have already done with other clinical candidate in conflicting sign, B) we can cover more injection as even after the fourth injection there turn out to be no antibody plateau, and C) we will certainly use these findings in our ongoing formulation development. But overriding importantly, the data schema chicly that we can use the body’s individual armour, the immune bundle of contacts, to modulate even such thorny requisites similar to addiction. This finding is extremely substantial with wonder to our pipeline of 27 vaccine candidates in other major creature area like high blood coercion, flabbiness or Alzheimer’s disease where on earth we use duplicate serious ImmunodrugTM rule.” More hearsay about the phase II study, the vaccine candidate CYT002-NicQb and nonspecific information about smoking and nicotine addiction can be found on About nicotine addiction According to the World Health Organization, 1.3 billion people smoke. With 5 million tobacco-related deaths per year, tobacco use is the prevailing bring of avoidable death in the world today.

Smoking harms nearly all organ of the unit and 30% of all cancer deaths, including 87% of deaths from lung cancer, are attributable to smoking (American Cancer Society, 2005). Nicotine, an alkaloid derived from tobacco leaves, has be shown to be the principal addictive piece of tobacco.

Upon inhalation of cigarette smoke, nicotine overrun into the bloodstream and within second penetrates through the blood-brain screen, where it stimulate specific neurons in the intelligence.

Stimulation of these neurons lead to the unbind of dispatch rider molecules, which furnish soar to an almost instant rate and a misgivings of ease. This sensory stimulus is accusing to the addictive magnificence of nicotine and causes a high slip back rate after quit attempt. Although nearly 75% of smokers in the U.S. story that they want to quit smoking, less than 5% of those who try quitting are competent to stay on tobacco-free for 3 to 12 months (Surgeon’s General Report, USA, 2004).

About CYT002-NicQb CYT002-NicQb is a medicinal vaccine in development for the treatment of nicotine addiction. Vaccination with CYT002-NicQb has been shown to win terminated high levels of nicotine-specific antibodies that tie up nicotine in the blood. As the complex of nicotine attached to an antibody is moreover hulking to pass the blood-brain-barrier, nicotine uptake into the brain and the subsequent excitement of nicotine-perceptive neurons in the brain is believed to be dreadfully reduced or even prevented. In this way the addiction-driving and satisfaction-inducing stimulus of nicotine is minimize.

About the phase II study The study, the largest ever achieve with a vaccine to treat nicotine addiction, was a randomized, doppelganger unsighted, placebo-controlled, multicenter phase II clinical trial to intermediary safety, tolerability and efficacy of the vaccine candidate. It was carried out at the Kantonsspital St. Gallen, the Centre Hospitalier Universitaire Vaudois (CHUV) Lausanne, and the Lung Center Hirslanden Zurich, all in Switzerland. The study was conduct in 341 hearty masculine and womanly smokers, aged 18-70 who have been smoking between 10 and 40 cigarettes per restrained of day for at smallest realistic 3 years and who were motivated to quit smoking. 5 injections of the vaccine or placebo were given at monthly interval at month 0, 1, 2, 3, and 4. All participant received smoking cessation counselling by the study collaborator at each pop in during three months. One month after the primary injection, the participants were observe with to gross a serious seek to quit smoking. Smoking tailor`s dummy run was text by the participants in personal diary, and independent biochemical validation was performed by method carbon monoxide in exhale air (a sequel of cigarette burn that flood in the blood for expert of 24 hours).

About the analysis Out of 341 smokers enrol in the study, all participants were included in the efficacy analysis from whom complete antibody measurements were available and who refrained from using nicotine replacement psychiatric therapy (NRT) (n239). NRT is believed to have a different effect on the two treatment group (CYT002-NicQb and placebo). Based on the proposed works of guidance, NRT products and the vaccine are anticipated to neutralize each other, whereas in smokers on placebo NRT has a familiar appreciative effect.

An intent-to-treat analysis of the inclusive study population has not achieved statistical deportment; and so, the sub-group analysis base on antibody levels was performed.

In this analysis, NRT user were excluded, latter, the vaccinate smokers with complete antibody measurements were divided into three groups of mounting antibody levels (low, medium, and high responder group), and efficacy analysis was performed on each group. The placebo group was treat identically: NRT users were excluded and all participants with complete antibody measurements were included. Study participants were count as continuously abstinent with the matchless come to an end when by any means visit between week 8 and 24 the carbon monoxide close attention in their exhaled air was downstairs 10 ppm and when for the period of the entire length between week 8 and 24 they declared themselves as being non-smokers.

Media and Analyst Conferences for CYT002-NicQb phase II study results Cytos Biotechnology will closure the following medium and analyst conference equal to the CYT002- NicQb phase II study results: - 2 Media Conferences on Tuesday, May 17, 2005, 10.30am (CET) at Cytos Biotechnology, Wagistrasse 25, CH-8952 Schlieren, and at the CHUV, Rue du Bugnon 46, CH-1011 Lausanne, breathing space “Andros” at level 8, room No 1205.

At Cytos Biotechnology in Schlieren: Dr. Wolfgang Renner, CEO, and Dr. Philipp Mller, Executive Vice President Clinical Development of Cytos Biotechnology, and the study investigators Dr.

Felix Jungi and Dr. Karl Klingler will be available for interview. The regime will be in German (or on order in English).

At the CHUV in Lausanne: Jakob Schlapbach, CFO of Cytos Biotechnology, and Prof. Dr. Jacques Cornuz, principal investigator of the study will be available for interviews. The presentation will be in French.

- Conference for analysts and saver on Tuesday, May 17, 2005, 2pm (CET) at Cytos Biotechnology, Wagistrasse 25, CH-8952 Schlieren.

Dr. Wolfgang Renner, CEO, and Dr. Philipp Mller, Executive Vice President Clinical Development of Cytos Biotechnology, and the study investigators Dr. Felix Jungi and Dr. Karl Klingler will be available for interviews. The presentation will be in English and will also be accessible by be a resident of webcast via the internet site About Cytos Biotechnology AG Cytos Biotechnology AG is a local Swiss biotechnology camaraderie that specialize in the revealing, development and commercialization of a new class of biopharmaceutical products - the ImmunodrugsTM. ImmunodrugsTM are used for use in the treatment and rein of common returning disease, which dog millions of people worldwide. ImmunodrugsTM are designed to programme the patient’s immune system to make desired therapeutic antibody or cytotoxic T-cell response that modulate chronic disease conduct yourself. Taking control of the high malleability of its ImmunodrugTM pulpit, Cytos Biotechnology has body type a pipeline of 27 different ImmunodrugTM candidates in mixed disease areas, of which six are at keepsake in clinical development.

The Immunodrug candidates are existing both in-house (24) and mutually with Novartis (1) and Pfizer Animal Health (2).

Founded in 1995 as a spin-off from the Swiss Federal Institute of Technology (ETH) in Zurich, the company is to be found in Schlieren (Zurich). Currently, the company has 110 driving force. Cytos Biotechnology AG has been programmed on the SWX Swiss Exchange (SWX:CYTN) since October 2002.

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