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Clinical Assessment

Clinical assessment is the cornerstone of Philip Morris International’s assessment program. Clinical studies assess whether the reduction in the formation of harmful and potentially harmful constituents (HPHCs) measured in the laboratory leads to a reduction in HPHC exposure under real-use conditions when an adult smoker switches to the product. Furthermore, they demonstrate whether switching from cigarettes to a candidate reduced-risk product has a beneficial effect on a smoker’s health profile. Clinical studies also help determine the extent to which adult smokers would find the product an acceptable alternative to cigarettes.

PMI has completed eight clinical studies on its novel Tobacco Heating System (THS, version 2.2) with a total of almost 900 adult smokers to date. PMI is also conducting clinical trials on its other candidate reduced risk products. The information about the eight THS 2.2 clinical studies as well as other relevant ongoing studies is summarized below.

Four pharmacokinetic and pharmacodynamic clinical studies investigating nicotine uptake, suppression of the urge to smoke, and subjective effects compared to cigarettes:

Two 5-day clinical studies in confinement investigating exposure reduction to harmful and potentially harmful constituents (HPHCs):

The results showed that the reduction in exposure to HPHCs measured in smokers who switched to THS approached the effect observed in smokers who quit smoking for the duration of the study. To learn more, visit:

Two 3-month clinical studies investigating exposure reduction to HPHCs over a longer period of time in a more real-life setting:

The results showed that the reduction in exposure to HPHCs measured in smokers who switched to THS approached the effect observed in smokers who quit smoking for the duration of the study. In both of these 3-month studies, PMI also measured six clinical risk markers. These clinical risk markers are reflective of disease mechanisms known to be affected by smoking and to reverse upon cessation. While these Reduced Exposure clinical studies were primarily designed to focus on biomarkers of exposure, the results are generally consistent with the expected direction of change and indicate that switching completely to THS led to an overall improvement of clinical risk markers affected by smoking after only three months.

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In addition to the eight completed studies, PMI is conducting longer term clinical studies to measure clinical risk markers known to be affected by smoking, and reverse upon cessation (so called “Exposure Response Study”). The study is designed to measure the reversal of clinical risk markers when smokers switch to THS over a 12-month period. The study is divided into two consecutive 6-month phases, focusing first on markers known to reverse more quickly and then on respiratory function, which takes more time. These results will be benchmarked against those of the Smoking Cessation Response study (below).

Close to 1,000 adult participants have enrolled in the study, and all participants have completed the first 6-month phase. More than 80% of the adult participants enrolled have agreed to continue for the full year. Top line results of the first 6-month phase are expected by the second quarter of 2017. The full 12-month results of the Exposure Response Study are expected by the first quarter of 2018.

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To establish a one-year “gold standard” of cessation for assessing candidate reduced risk products, PMI is conducting the Smoking Cessation Response study across a number of countries, which measures the reversal of clinical risk markers when adult smokers quit smoking for one year.

Over 1,100 adult participants have enrolled. A 6-month interim data report is expected by the third quarter of 2017, while the full 12-month results with be available by the first quarter of 2018.

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Further, PMI has initiated an observational cohort study in Japan to assess the patterns of product use and population-level differences in clinical risk endpoints between THS users and combustible cigarette smokers. The so-called LYFE Study will enroll 2000 THS users, 2000 conventional smokers and 760 never-smokers over a period of four years in equally distributed annual waves, and it will follow participants for up to 5 years. The study is designed to assess how consumers use of tobacco and nicotine products change over time, the patterns of product use, and behavioral trajectories of smoking.

In addition, a Clinical Sub-Study will enroll 2,280 participants, 760 THS consumers, matched 1:1 with conventional cigarette smokers and never-smokers. Participants in the Clinical Sub-Study will have two clinical site visits (at 1 and 3 years) to perform physical exams and collect biological samples to assess population-level differences in biomarkers of exposure and clinical risk endpoints.

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