Safety and Efficacity of NFL101 as Tobacco Therapy

Smoking Clinical Trial

— CESTO  

Official title:

Phase I Study Assessing Safety and Efficacity of NFL101 as Tobacco Therapy(CESTO)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02521701
• Other study ID #: ICM2014/34
• Status: Completed
• Phase: Phase 1
• First received: March 3, 2015
• Last updated: August 10, 2017
• Start date: December 2014
• Est. completion date: August 2016

Study information

• Verified date: August 2017
• Source: Institut du Cancer de Montpellier - Val d'Aurelle
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This Phase I study is to investigate the safety of two dose levels of NFL-101 in smokers.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Male or female subjects = 18 and = 70 years old

• ECOG/OMS performance status 0-1

• Subjects currently smoking at least 11 cigarettes per day and with a dependency level = 5 according to Fagerstöm scoring

• Subjects willing to quit smoking

• Good general health (i.e. no uncontrolled medical condition)

• Good mental health (i.e. no alcohol or drug abuse in the past year, no psychiatric history- adequately treated depression is accepted).

• For women of childbearing age: adequate contraception at least until 28 days after the second injection

• French speaking

• Patients must be affiliated to a social security system

• Informed consent agreement and signature

Exclusion Criteria:

• Pregnancy and breastfeeding

• Concomitant participation to another clinical trial

• Concomitant active infectious diseases

• Concomitant desensitization therapy

• History of asthma or immune disorders

• History of any allergy including to nicotine or any components of study product

• Uncontrolled diabetes

• Use of corticosteroids, systemic steroids, antihistamines or immunosuppressive agents within 30 days prior to the study start

• Prior exposure to a nicotine vaccine or to any other vaccine within 30 days before study product administration

• Use of any therapy of smoking cessation within 90 days (including use of electronic cigarettes and alternative methods such as hypnosis or acupuncture)

• Legal incapacity or physical, psychological or mental status interfering with the subject's ability to sign the informed consent or to terminate the study

Related Conditions & MeSH terms

• Smoking

Intervention

Drug:
• NFL101
Level 1: 100 µg 50 µg per injection (in each arm), two injections at day 1 and two injections at day 29 The 140 µg must be diluted in 2.8 mL of dilution solution in order to obtain a 50 µg.mL-1 concentration. Level 2: 200 µg 100 µg per injection (in each arm), two injections at day 1 and two injections at day 29 The 140 µg must be diluted in 1.4 mL of dilution solution in order to obtain a 100 µg.mL-1 concentration. Therefore, for this level only, two vials are needed to inject 2 x 1.0 mL.

Locations

Country	Name	City	State
France	Institut du Cancer de Montpellier - Val d'Aurelle	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
Institut du Cancer de Montpellier - Val d'Aurelle

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events as a Measure of safety in smoking subjects.	to access safety of NFL 101	1 year
Secondary	to determine immunogenicity of NFL 101	Response rate as a mesure of efficacy of NFL 101 in smoking subjects.	1 year