Vaccine for nicotine addiction NIC002 flunks: Cytos

Novartis, which bought the rights to the NIC002, will continue to develop the anti-smoking vaccine

Nicotine vaccine NIC002, a much anticipated preventive measure to stop smoking currently being developed by Cytos Biotechnology Ltd has failed in clinical studies.

NIC002 is a therapeutic vaccine in development for the treatment of nicotine addiction.

Nicotine vaccine NIC002 failed to achieve the primary endpoint in an interim analysis of a Phase II study.

Nicotine vaccine NIC002′s primary endpoint was defined as a statistically significant difference in continuous abstinence from smoking determined from weeks 8 to 12 after start of treatment compared to placebo.

Nicotine vaccine NIC002′s ongoing double blind, placebocontrolled,multi-centre is to evaluate the efficacy, safety, tolerability and immunogenicity of repeated administrations of 100?g NIC002 in 200 cigarette smokers who are motivated to quit smoking.

Vaccination with NIC002 has been shown to induce nicotine-specific antibodies that bind nicotine in the bloodstream. As the complex of nicotine attached to an antibody is too large to cross the bloodbrain barrier, nicotine uptake into the brain and the subsequent stimulation of nicotine-responsive nerve cells is believed to be reduced.

In this way, the reward-inducing and addiction-driving stimulus of nicotine should be minimized and abstinence from smoking more easily achieved and maintained.

In a previous Cytos phase II clinical trial the vaccine has promoted and sustained long-term abstinence from smoking in the subgroup of smokers that achieved high antibody levels upo vaccination.

Novartis bought the rights to the Cytos NIC002 anti-smoking vaccine in 2007 in a deal valued up to 600 million francs, including an upfront payment of 35 million francs, with further payments promised on development milestones.

Novartis will continue the study in order to collect more long-term data on the efficacy and safety of NIC002 and will decide on the next steps once the scheduled 12 month duration of the clinical trial is completed and when all data have been analyzed, Cytos said in an official release.

In a previous Cytos phase II clinical trial the vaccine has promoted and sustained long-term abstinence from smoking in the subgroup of smokers that achieved high antibody levels upon vaccination.

What is nicotine addiction?

Nicotine is a plant-derived alkaloid and the principal addictive component of tobacco. Upon inhalation of cigarette smoke, nicotine passes into the bloodstream and, within seconds, crosses the blood-brain barrier to enter the brain where it stimulates specific nerve cells.

Stimulation of these nerve cells leads to the release of messenger molecules, which give rise to an almost immediate reward and feeling of pleasure. This sensory stimulus is critical to the addictive properties of nicotine and causes a high relapse rate after quitting attempts. Although nearly 75% of smokers in the U.S.report that they want to stop smoking, less than 5% of those who make an attempt are able to stay tobacco-free for 3 to 12 months (CDC, USA; Surgeon General’s Report, 2004).

There are 1.3 billion smokers and with 4.9 million tobacco-related deaths per year, worldwide. Tobacco use is the leading cause of preventable death in the world today (WHO; Facts about smoking and health, 2006). Smoking harms nearly every organ of the body, resulting in life-threatening diseases like cancer, chronic obstructive pulmonary disease (COPD), stroke, and circulation disease.

Cytos Biotechnology Ltd is a public Swiss biotechnology company that specializes in the discovery, development and commercialization of a new class of biopharmaceutical products – the Immunodrugs. Immunodrugs are intended for use in the treatment and prevention of common chronic diseases, which afflict millions of people worldwide. Immunodrugs are designed to instruct the patient’s immune system to produce desired therapeutic antibody or T cell responses that modulate chronic disease processes.

The Immunodrug candidates are developed both in-house and together with Novartis, Pfizer and Pfizer Animal Health.

Founded in 1995 as a spinoff from the Swiss Federal Institute of Technology (ETH) in Zurich, the Company is located in Schlieren (Zurich).

Cytos’ high blood pressure vaccine which was being developed with Pfizer too failed to meet its target in a mid-stage trial, this year.