PMI’s latest study sets another milestone in assessing the harm reduction potential of IQOS.

• The study adds to the extensive evidence package available on IQOS, PMI’s most advanced smoke-free product, further confirming that switching to it completely is likely to reduce the risk of smoking related diseases versus continued smoking
• Lifetime A/J mouse[1] inhalation study shows reduced incidence and multiplicity of lung carcinomas in mice exposed to IQOS aerosol, compared to those exposed to cigarette smoke
• Reiterates request for KFDA to clarify its conclusions on heated tobacco products to avoid confusion among consumers
• Focus should be on the totality of evidence including non-clinical and clinical studies, and not on “Tar” which is globally recognized as non-indicative of potential risk or harm, and possibly misleading to consumers

LINK TO PRESENTATION AVAILABLE HERE.

Seoul, Korea, August 30, 2018 -- Today Philip Morris International presented positive results from its latest non-clinical study, an 18-month inhalation study in A/J mice to compare the effects of IQOS aerosol with those of cigarette smoke and air.

A/J mice are known to develop lung emphysema and lung cancer in response to cigarette smoke exposure. In the 18-month life-long study, female A/J mice were exposed to either air, cigarette smoke or IQOS aerosol, while male mice were exposed to either air or IQOS aerosol. The results show that incidence and multiplicity of lung carcinomas was significantly increased upon exposure to cigarette smoke compared to air exposure. In contrast, incidence and multiplicity of lung carcinomas in IQOS exposed mice was significantly lower compared to cigarette smoke exposed mice and similar to air exposed mice. The study concluded that IQOS reduces genetic damage and inflammation compared to continued smoking as well as incidence and multiplicity of lung carcinomas in a validated cancer animal model.

Manuel Peitsch, PMI’s Chief Scientific Officer said: “To our knowledge, this is the first inhalation study which provides evidence on the potential impact of a smoke-free product on cancer development. This milestone study further strengthens the scientific evidence showing that switching to IQOS is a better choice for smokers than continuing to smoke cigarettes. However, cessation remains the best choice.”  

Philip Morris Korea Inc. further took the opportunity to call on the Korean Food and Drug Administration (KFDA) to clarify its 7th June conclusions on heated tobacco products, while their own analysis like other independent international studies confirmed that the levels of the nine chemicals tested in the aerosol of heated tobacco products were on average 90% lower when compared to the top five cigarette brands in Korea. Despite these findings the KFDA chose to focus its conclusion on measurements of “Tar”, which the World Health Organization (WHO) has said is not a sound basis for regulation, and can be misleading.

PMI has been conducting extensive research to confirm the risk reduction potential of IQOS, with 18 non-clinical and 10 clinical studies. These studies assess not only the reduced emission of harmful chemicals, but also the reduced exposure in humans and the reduced adverse health effects of switching versus continued smoking, i.e. the entire causal chain of events linking smoking to disease. In addition to PMI’s research, there is a growing number of studies and reviews of available evidence whose findings are in line with PMI’s. These include reviews by the US Food and Drug Administration’s Southeast Tobacco Laboratory and the Committee on Toxicity of the UK Government, as well as the German Federal Institute for Risk Assessment.

 

Standards for Animal Care and Use

Our non-clinical assessments are performed under Good Laboratory Practice (GLP). GLP ensures uniformity, consistency, reliability, reproducibility, quality and integrity in the methodology of the tests and therefore the results.

As part of our strategy to “Replace, Reduce and Refine” in vivo testing, we are actively working on new in vitro models in the hope that one day in vitro models could completely replace non-human in vivo assays. When in vivo studies are necessary, we use rodents in precise and well controlled inhalation studies. The facility in which we conduct these studies is accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) which is testament to the level of care and humane treatment of the rodents that we use.

We have a 2-step process to ensure that we are conducting only necessary studies in the most ethical way. Our corporate PMI Animal Welfare Committee reviews all proposed animal studies to evaluate whether study objectives are achievable, or whether the objectives can be achieved through other testing means. We also have an Institutional Animal Care and Use Committee (IACUC), which further evaluates the experimental procedures in detail and makes sure that any opportunity to apply the “Replace, Reduce and Refine” strategy is implemented.

Furthermore, we adhere to the Animal Research: Reporting of In Vivo Experiments (ARRIVE) guidelines, published by the National Center for the Replacement, Refinement and Reduction of Animals in Research and intended to improve the reporting of research using animals, maximizing information published and thus minimizing the performance of unnecessary studies.

[1] Study conducted with specially bred A/J mouse strain. It is highly susceptible to lung tumor development and has been widely used as a screening system in carcinogenicity testing.