Smoking Clinical Trial
Official title:
Phase I Study Assessing Safety and Efficacity of NFL101 as Tobacco Therapy(CESTO)
This Phase I study is to investigate the safety of two dose levels of NFL-101 in smokers.
Tobacco addiction is one of the biggest public health threats the world has ever faced,
killing nearly six million people a year. There are more than 1 billion smokers in the world,
up to half will eventually die of a tobacco-related disease. Nicotine replacement treatments
were the first pharmacological treatments approved for use in smoking cessation therapy and
include nicotine gums, transdermal patches, tablets, nasal sprays, and inhalation systems.
More recently, buproprion and varenicline were approved but showed limiting side effects. The
development of safe and efficient alternatives for this indication is now called for.
Tobacco cessation cases were observed concomitantly with the administration of a
desensitization treatment against tobacco allergy. Based on these observations, NFL
Biosciences developed a drug candidate for tobacco cessation. This new drug (NFL 101) was
assessed in preclinical studies. Notably, regulatory genotoxicity (Institut Pasteur de Lille)
and toxicity studies in rats (Ricerca, Wil Research, Lyon) showed no toxicity. The NFL 101
composition and the low doses injected led to propose a mechanism of action based on an
immune response. Immunogenicity studies conducted with the European Georges Pompidou Hospital
(HEGP) on peripheral blood mononuclear cells and rodents have supported such hypotheses.
Therefore, the objective of this Phase I study is to investigate the safety of two dose
levels of NFL-101 in smokers.
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