Gene Modulation by Peptide Nucleic Acids (PNAs) Targeting microRNAs (miRs)

Since non-viral gene therapy was developed and employed in different in vitro and in vivo experimental systems as an effective way to control and modify gene expression, RNA has been considered as a molecular target of great relevance (Li &Huang, 2008, López-Fraga et al., 2008). In combination with standard chemotherapy, the siRNA therapy can reduce the chemoresistance of certain cancers, demonstrating its potential for treating many malignant diseases. Examples of RNA sequences to be targeted for therapeutic applications are mRNAs coding oncoproteins or RNA coding anti-apoptotic proteins for the development of anti-cancer therapy. In the last years, progresses in molecular biology have allowed to identify many genes Coding for small non coding RNA molecules, microRNA (miRNAs or miRs), able to regulate gene expression at the translation level (Huang et al., 2008, Shrivastava & Shrivastava, 2008, Sahu et al. 2007, Orlacchio et al., 2007, Williams et al., 2008, Papagiannakopoulos & Kosik, 2008). Accordingly, an increasing number of reports associate the changed expression with specific phenotypes and even with pathological conditions (Garzon & Croce, 2008, Mascellani et al., 2008, Sontheimer & Carthew, 2005, Filipowicz et al., 2005, Alvarez-Garcia & Miska, 2005). Interestingly, microRNAs play a double role in cancer, behaving both as oncogenes or tumor suppressor genes. In general, miRs promoting cancer targets mRNA coding for tumor-suppression proteins, while microRNAs exhibiting tumor-suppression properties usually target mRNAs coding oncoproteins. MicroRNAs which have been demonstrated to play a crucial role in the initiation and progression of human cancer are defined as oncogenic miRNAs (oncomiRs) (Cho, 2007). The oncomiR expression profiling of human malignancies has also identified a number of diagnostic and prognostic cancer signals (Cho, 2007, Lowery et al., 2008). Moreover, microRNAs have been firmly demonstrated to be involved in cancer metastasis (metastamiRs). Examples of metastasis-promoting microRNAs are, miR-10b (Calin et al., 2006), miR-373 and - 520c (Woods et al., 2007), miR-21, -143 and -182 (Hayashita et al., 2005; Si et al., 2007; Zhu et al.,2007). Reviews on metastamiR has been recently published Hurst et al. (Hurst et al. 2009, Edmonds et al. 2009). Reviews on metastamiRs has been recently published by Hurst et al

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to ♀EFAX™ and reduction of menstrual discomfort pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Following an application from Nutrilinks Sarl submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Cyprus, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to ♀EFAX™ and reduction of menstrual discomfort. The food, ♀EFAX™, which is standardised pure krill oil and is the subject of the health claim, is sufficiently characterised. The claimed effect, reduction of menstrual discomfort, is a beneficial physiological effect. No human intervention studies from which conclusions could be drawn for the scientific substantiation of the claim were provided by the applicant. A cause and effect relationship has not been established between the consumption of ♀EFAX™ and reduction of menstrual discomfort

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2013. Scientific Opinion on the substantiation of a health claim related to “non - fermentable ” carbohydrates and maintenance of tooth mineralisation by decreasing tooth demineralisation pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Following an application from Roquette Frères, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to Nutriose® which should replace “fermentable carbohydrates” in foods or beverages in order to obtain the claimed effect, i.e. maintenance of tooth mineralisation by reducing tooth demineralisation. From the information provided, the Panel noted that the main characteristic of carbohydrates which is relevant to the claimed effect is the rate and amount of acid production resulting from their fermentation by saccharolytic bacteria in the oral cavity. This Opinion applies to “non-fermentable” carbohydrates, which should replace “fermentable” carbohydrates in foods or beverages in order to obtain the claimed effect. The Panel considers that maintaining tooth mineralisation by reducing tooth demineralisation resulting from acid production in plaque caused by the fermentation of carbohydrates is a beneficial physiological effect. The Panel concludes that a cause and effect relationship has been established between the consumption of foods/beverages containing “fermentable” carbohydrates at an exposure frequency of four or more times daily and an increased tooth demineralisation, and that the consumption of foods/beverages containing “non-fermentable” carbohydrates instead of “fermentable” carbohydrates may maintain tooth mineralisation by decreasing tooth demineralisation. In order to bear the claim, “fermentable” carbohydrates should be replaced in foods or beverages by “non-fermentable” carbohydrates, so that consumption of such foods or beverages does not lower plaque pH below 5.7 during and up to 30 minutes after consumption, and does not lead to dental erosion

EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2013 . S tatement on the safety of ' Cetyl Myristoleate Complex ' as an ingredient in food supplements

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to update its opinion on the safety of ‘Cetyl Myristoleate Complex’ (CMC) as a novel food ingredient in the light of a new repeated dose 90-day oral toxicity study in mice. In its previous opinion of 2010, the Panel concluded that based on the available data, the safety of CMC as an ingredient in food supplements has not been established. This conclusion was based on the considerations that in the absence of appropriate data on absorption, distribution, metabolism and excretion, the provided toxicological data were insufficient. Whereas the applicant considers that the NOAEL of CMC in this new 90-day study was 1000 mg/kg body weight (bw), the highest dose tested, the Panel considers that this study and study report has many shortcomings to be a reliable source of information supporting the absence of adverse effects of the parent material CMC. The Panel concludes that the safety of 'Cetyl Myristoleate Complex' has not been established

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to E<em>ff</em>_EXT™ and maintenance of normal joint mobility pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Following an application from Nutrilinks Sarl, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to EffEXT™ and maintenance of normal joint mobility. The Panel considers that EffEXT™, which is standardised pure krill oil, is sufficiently characterised. The claimed effect proposed by the applicant is “contributes to support joint flexibility”. The Panel considers that maintenance of normal joint mobility is a beneficial physiological effect. The applicant identified one human intervention study as being pertinent to the health claim. The Panel notes that chronic inflammation was an inclusion criterion of the study, that a significant number of the patients recruited were reported to have confirmed diagnosis of osteoarthritis, rheumatoid arthritis, or of both cardiovascular disease and osteoarthritis, and that the WOMAC osteoarthritis questionnaire was administered only to patients with arthritic disease (osteoarthritis or rheumatoid arthritis). The Panel also notes that no evidence which could justify the extrapolation of the results, obtained in patients with joint diseases characterised by chronic inflammation, to the target population, subjects without chronic joint diseases, was provided by the applicant. The Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claim. The Panel concludes that a cause and effect relationship has not been established between the consumption of EffEXT™ and maintenance of normal joint mobility