Nicotine by itself does not induce an antibody or immune response. However, when conjugated with an immunogenic protein such as recombinant cholera protein, an immune response is generated. These anti-nicotine antibodies may bind to the nicotine in a smoker’s blood and decrease or reduce the positive effects that nicotine creates in the smoker. In the Phase I trial, TA-NIC was delivered by 5 vaccinations over 8-20 weeks with a booster given 9 months after the first injection.

According to the 2001 National Health Interview Survey, approximately 22.8% of American adults (46.2 million) are currently smokers. Smoking rates in the United States have been declining since 1965.

The Biohorizon Emerging Health Technology Database contains two other emerging technologies for the treatment of Nicotine Addiction/Smoking Cessation, NicVax and Acomplia™. Notably, Nabi Pharmaceutical’s NicVax is another Phase I therapeutic vaccine, while Sanofi’s Acomplia™ is a Phase III drug therapy under development for both obesity and smoking cessation.

TA-NIC is an early stage therapeutic vaccine for smoking cessation with interesting Phase I trial results and substantial obstacles in the form of pivotal Phase 3 trials to overcome. We currently recommend no assessment activities for health services clients at this time.

Technology Details
Target Disease / Indication: Smoking Cessation/Nicotine Addiction
Technology Classification: Drug
Body System: Nervous System
Program Area: Medicine/Addictions
Regulatory Status: Phase I
BioHorizon Impact Score: 53/100 – Moderate

AVP 13358 is an orally active compound thought to exert its action through decreasing the production of IgE. It is generally accepted that IgE (immunoglobulin epsilon) plays an important role in the inflammatory response that produces many of the signs and symptoms of asthma and other allergic diseases. Other mediators of inflammation, such as IL-4 and IL-5, may also be suppressed by AVP 13358. According to Avanir, pre-clinical data suggests that AVP 13358 suppresses markers of disease in mouse models of asthma, including pulmonary lavage levels of IL-4, IL-5, eosinophils, and lymphocytes as well as expression of CD23 and the IL-4 receptor (IL4R(alpha)) on leukocytes.

Asthma is a chronic disease of the lungs characterized by recurring episodes of wheezing, breathlessness, chest tightness, and nighttime or early morning coughing. According to CDC surveillance data during 1980-1996, asthma prevalence in the United States has increased. Between 1995 and 1999, the rate of outpatient visits and emergency department visits for asthma has also increased, while the rates of hospitalization and death decreased. In 1996, an estimated 14.6 million persons (54.6/1,000 population) reported asthma during the previous 12 months in 1996. The pharmaceutical market for asthma therapeutics is estimated to be well in excess of 3 billion dollars per annum in the United States.

The Biohorizon Emerging Health Technology Database contains 49 technologies listing asthma as their main disease indication. 11 of these are in Phase I of development, and 25 are at the Phase II stage or beyond. While the Phase I clinical trial results for AVP 13358 are encouraging, this technology requires no preliminary assessment activities by health services delivery clients at this time.

Technology Details
Target Disease / Indication: Asthma
Technology Classification: Drug
Body System: Respiratory System
Program Area: Medicine/Respirology
Regulatory Status: Phase I
BioHorizon Impact Score: 50/100 – Moderate