[{"command":"openDialog","selector":"#drupal-modal","settings":null,"data":"\u003Cdiv id=\u0022republish_modal_form\u0022\u003E\u003Cform class=\u0022modal-form-example-modal-form ecl-form\u0022 data-drupal-selector=\u0022modal-form-example-modal-form\u0022 action=\u0022\/en\/article\/modal\/6589\u0022 method=\u0022post\u0022 id=\u0022modal-form-example-modal-form\u0022 accept-charset=\u0022UTF-8\u0022\u003E\u003Cp\u003EHorizon articles can be republished for free under the Creative Commons Attribution 4.0 International (CC BY 4.0) licence.\u003C\/p\u003E\n \u003Cp\u003EYou must give appropriate credit. We ask you to do this by:\u003Cbr \/\u003E\n 1) Using the original journalist\u0027s byline\u003Cbr \/\u003E\n 2) Linking back to our original story\u003Cbr \/\u003E\n 3) Using the following text in the footer: This article was originally published in \u003Ca href=\u0027#\u0027\u003EHorizon, the EU Research and Innovation magazine\u003C\/a\u003E\u003C\/p\u003E\n \u003Cp\u003ESee our full republication guidelines \u003Ca href=\u0027\/horizon-magazine\/republish-our-stories\u0027\u003Ehere\u003C\/a\u003E\u003C\/p\u003E\n \u003Cp\u003EHTML for this article, including the attribution and page view counter, is below:\u003C\/p\u003E\u003Cdiv class=\u0022js-form-item form-item js-form-type-textarea form-item-body-content js-form-item-body-content ecl-form-group ecl-form-group--text-area form-no-label ecl-u-mv-m\u0022\u003E\n \n\u003Cdiv\u003E\n \u003Ctextarea data-drupal-selector=\u0022edit-body-content\u0022 aria-describedby=\u0022edit-body-content--description\u0022 id=\u0022edit-body-content\u0022 name=\u0022body_content\u0022 rows=\u00225\u0022 cols=\u002260\u0022 class=\u0022form-textarea ecl-text-area\u0022\u003E\u003Ch2\u003EDrug testing breakthrough sees side effects before they happen\u003C\/h2\u003E\u003Cp\u003EIn total, 95 % of all potential drugs fail during development, and half of these fail during large-scale trials, which are usually the last hurdle they have to clear before regulators decide whether to approve them for use.\u003C\/p\u003E\u003Cp\u003EHowever, scientists have discovered that some molecules in the body, which could indicate potential side-effects, appear long before there is any major damage to organs, meaning that drug development could be abandoned earlier if a problem is detected.\u003C\/p\u003E\u003Cp\u003ESince 2009, a group of scientists has scrutinised 100 of these molecules, known in the industry as biomarkers, and discovered a couple of promising candidates for kidney, liver and blood vessel damage.\u003C\/p\u003E\u003Cp\u003E\u2018These biomarkers tell us about the likelihood that, for example, a specific patient may progress to severe injury and raise warning flags,\u2019 said Dr Michael Merz, a drug safety expert based in Germany at pharmaceuticals firm Novartis and coordinator of the EU-funded SAFE-T project, which is behind the research.\u003C\/p\u003E\u003Cp\u003EFor example, with many drugs, some patients may show signs of liver injury initially, but then mostly adapt. With the new biomarkers, scientists hope they can spot those patients who are instead on course for unacceptable organ injury.\u003C\/p\u003E\u003Cp\u003E\u2018We now have a couple of markers that apparently can predict which patients may progress to liver failure,\u2019 said Dr Merz.\u003C\/p\u003E\u003Cp\u003E\u003Cstrong\u003ESystematic\u003C\/strong\u003E\u003C\/p\u003E\u003Cp\u003EAlthough many biomarkers for drug safety have previously been investigated by scientists, using them to flag side effects had not been checked in patients in a systematic way.\u003C\/p\u003E\u003Cp\u003EThe SAFE-T project\u2019s mission was to investigate the most promising biomarkers in real patients, such as those receiving cancer drugs known to cause harmful side effects. They also tested for the moledules in tissue samples held by pharmaceutical companies from diabetic, rheumatoid arthritis, tuberculosis and cancer patients, among others.\u003C\/p\u003E\u003Cp\u003E\u2018Pharmaceutical companies are already benefitting by using these markers in their clinical trials so that they can see, say, kidney damage, even if it\u2019s only a small percentage of cells being damaged,\u2019 said Dr Thomas Joos, the scientific lead of the project at the University of T\u00fcbingen, Germany.\u003C\/p\u003E\u003Cp\u003EThe biomarker approach has received encouragement in the form of letters of support from European and US drug regulatory bodies.\u003Cblockquote class=\u0022tw-text-center tw-text-blue tw-font-bold tw-text-2xl lg:tw-w-1\/2 tw-border-2 tw-border-blue tw-p-12 tw-my-8 lg:tw-m-12 lg:tw--ml-16 tw-float-left\u0022\u003E\n \u003Cspan class=\u0022tw-text-5xl tw-rotate-180\u0022\u003E\u201c\u003C\/span\u003E\n \u003Cp class=\u0022tw-font-serif tw-italic\u0022\u003E\u2018Whatever the benefit of a drug to patients, even if making cardiac disease better, it\u2019s unacceptable to cause cancer.\u2019 \u0026amp;nbsp;\u003C\/p\u003E\n \u003Cfooter\u003E\n \u003Ccite class=\u0022tw-not-italic tw-font-normal tw-text-sm tw-text-black\u0022\u003EDr Jonathan Moggs, Novartis\u003C\/cite\u003E\n \u003C\/footer\u003E\n\u003C\/blockquote\u003E\n\u003C\/p\u003E\u003Cp\u003EThe project also led to a new company, SIGNATOPE, which plans to introduce predictive tests for kidney injury in dogs, cats, rats and monkeys. This could serve the industry in its quest for new and safe drugs, while also removing the need for unnecessary animal tests.\u003C\/p\u003E\u003Cp\u003E\u003Cstrong\u003EGenes\u003C\/strong\u003E\u003C\/p\u003E\u003Cp\u003EA separate group of scientists have found a way to predict whether drugs might cause cancer by identifying tell-tale molecules which interfere with how genes work, turning them on or off.\u003C\/p\u003E\u003Cp\u003E\u2018Whatever the benefit of a drug to patients, even if making cardiac disease better, it\u2019s unacceptable to cause cancer,\u2019 said Dr Jonathan Moggs, a researcher at Novartis in Switzerland.\u0026nbsp;\u2018Cancer risk assessment is especially important for medicines given to patients for long periods of time.\u0027\u003C\/p\u003E\u003Cp\u003EHe coordinates the MARCAR project which, like SAFE-T,\u0026nbsp;has been funded under the Innovative Medicines Initiative, a public-private partnership between the EU and the European Federation of Pharmaceutical Industries and Associations, which aims to speed up the development of better and safer medicines for patients.\u003C\/p\u003E\u003Cp\u003E\u003Ca href=\u0022http:\/\/bit.ly\/newsalertsignup\u0022 target=\u0022_blank\u0022 rel=\u0022noopener noreferrer\u0022\u003E\u003Cimg src=\u0022https:\/\/horizon-magazine.eu\/research-and-innovation\/sites\/default\/files\/hm\/news-alert-final.jpg\u0022 width=\u0022983\u0022 height=\u0022222\u0022 \/\u003E\u003C\/a\u003E\u003C\/p\u003E\u003Cp\u003E\u003Cspan style=\u0022font-size: 13.008px;\u0022\u003EOne promising molecule identified by \u003C\/span\u003E\u003Cspan style=\u0022font-size: 13.008px;\u0022\u003EMARCAR researchers\u0026nbsp;\u003C\/span\u003E\u003Cspan style=\u0022font-size: 13.008px;\u0022\u003Eseems to flag when liver cells are being set back to an early stage, which represents one step on the road towards cancer.\u003C\/span\u003E\u003C\/p\u003E\u003Cp\u003E\u2018This is very exciting, because there is a lack of predictive biomarkers in the field of drug-induced tumour formation,\u2019 said Dr Moggs. \u2018A good biomarker might be sensitive enough to be detectable after only a few weeks.\u2019\u003C\/p\u003E\u003Cp\u003EThe idea would be to stack a selection of markers up for testing, strengthening any predictions made. The hope is for regulatory authorities to one day accept some of these tell-tale molecules as alternatives to carrying out two-year animal tests.\u003C\/p\u003E\u003Cp\u003E\u003Cem\u003EIf you liked this article, please consider sharing it on social media.\u003C\/em\u003E\u003C\/p\u003E\u003C\/textarea\u003E\n\u003C\/div\u003E\n\n \u003Cdiv id=\u0022edit-body-content--description\u0022 class=\u0022ecl-help-block description\u0022\u003E\n Please copy the above code and embed it onto your website to republish.\n \u003C\/div\u003E\n \u003C\/div\u003E\n\u003Cinput autocomplete=\u0022off\u0022 data-drupal-selector=\u0022form-su0a0h55ohayobcbe5wpw-wx-f1ecrh6igmpc-ufiu8\u0022 type=\u0022hidden\u0022 name=\u0022form_build_id\u0022 value=\u0022form-SU0A0h55OhayoBCbe5wPW-wX_F1eCrH6IgMPC-UFIU8\u0022 \/\u003E\n\u003Cinput data-drupal-selector=\u0022edit-modal-form-example-modal-form\u0022 type=\u0022hidden\u0022 name=\u0022form_id\u0022 value=\u0022modal_form_example_modal_form\u0022 \/\u003E\n\u003C\/form\u003E\n\u003C\/div\u003E","dialogOptions":{"width":"800","modal":true,"title":"Republish this content"}}]