{"id":1949,"date":"2021-02-16T14:20:27","date_gmt":"2021-02-16T14:20:27","guid":{"rendered":"http:\/\/www.barnaclinic.com\/blog\/en\/?p=1949"},"modified":"2021-02-22T14:21:43","modified_gmt":"2021-02-22T14:21:43","slug":"car-t-leukaemia","status":"publish","type":"post","link":"https:\/\/www.barnaclinic.com\/blog\/en\/blog\/car-t-leukaemia\/","title":{"rendered":"The AEMPS approves the use of a CAR-T therapy developed by the Hospital Cl\u00ednic Group for the treatment of a type of leukaemia"},"content":{"rendered":"

In recent years, cancer treatment<\/strong><\/a> has been revolutionised by immunotherapy<\/strong><\/a>, an approach that uses a patient’s own immune system to attack tumour cells<\/strong>. The Spanish Agency of Medicines and Medical Devices<\/a> (AEMPS) has just approved ARI-0001, a CAR T-cell therapy (a type of immunotherapy<\/strong><\/a>) developed entirely by the Hospital Cl\u00ednic Group, for use as a medicinal product. This is the first time that a treatment with genetically modified cells developed entirely in Europe has been approved by a regulatory agency<\/strong>, and it is also the first time that it has been done without the backing of a pharmaceutical company.<\/p>\n

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CAR-T ARI-0001\u00a0<\/strong>has been approved for the treatment of lymphoblastic leukaemia<\/strong> patients over the age of 25 who fail to respond to any of the conventional treatments currently available. This condition is one of the four most common groups of leukaemia and causes the excessive production of immature lymphocytes, which end up supplanting the normal cells in the bone marrow. Although patients generally respond well to chemotherapy treatments, between 10% and 15% of patients die. This may be because they end up developing resistance to the treatment, or because of its toxicity or relapses. Until now, these patients had no therapeutic alternatives, as this is an orphan disease.<\/p>\n

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CAR-T ARI-0001\u00a0<\/strong>has been approved for the\u00a0treatment of lymphoblastic leukaemia<\/strong>\u00a0patients over the age of 25 who fail to respond to any of the conventional treatments currently available<\/h4>\n<\/blockquote>\n

Key to being able to develop this drug has been the ARI Project<\/strong><\/a>, an initiative conceived from the dream of Ari Bened\u00e9<\/strong>, a young girl diagnosed with the condition who, along with her mother, started this project, which has raised around 1.8 million euros for the research and development of this CAR-T therapy<\/strong>. Dr Josep M. Campistol<\/strong>, Managing Director of the Hospital Cl\u00ednic, stressed that, \u201cthis achievement has been possible thanks to the joint effort of many of the hospital’s professionals and researchers who have participated in the various stages of treatment development, from the fine-tuning of CAR-T to the completion of the trial, in order to demonstrate its effectiveness. We have also had the support of broader society, through the ARI Project, to bring this project to fruition, one which reflects the Hospital Clinic’s vocation of offering our patients the most innovative treatment alternatives\u201d<\/em>.<\/p>\n

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\"Josep\u201cThis achievement has been possible thanks to the joint effort of many of the hospital’s professionals and researchers who have participated in the various stages of treatment development, from the fine-tuning of CAR-T to the completion of the trial, in order to demonstrate its effectiveness. We have also had the support of broader society, through the ARI Project, to bring this project to fruition, one which reflects the Hospital Clinic’s vocation of offering our patients the most innovative treatment alternatives<\/em><\/h4>\n

Dr\u00a0Josep M. Campistol<\/strong>, Managing Director of the Hospital Cl\u00ednic<\/p><\/blockquote>\n

CAR-T, a<\/strong>\u00a0medicine that is tailor made for each patient<\/strong><\/h2>\n

The so-called CAR-T therapies<\/strong> are one of the most personalised approaches that exist in the treatment of cancer<\/strong>. In an initial phase, T-lymphocytes<\/strong>, white blood cells that are responsible for the immune response, are extracted from the patient’s blood. Then, in the laboratory, these T-lymphocytes<\/strong> are genetically reprogrammed. Finally, they are reintroduced into the patient so that they can recognise and attack tumour cells, without harming healthy ones.<\/p>\n

That fact that it is a medicine that is tailor-made for each patient means that it is very expensive, in excess of 300,000 euros per patient in the United States, and represents a challenge for many health systems. The version that has been developed by the Hospital Cl\u00ednic Group manages to greatly reduce its cost<\/strong>, rendering it substantially cheaper.<\/p>\n

CAR-T ARI-0001, d<\/strong>eveloped entirely by the Hospital Cl\u00ednic Group<\/strong><\/h2>\n

The AEMPS approval of the use of CAR-T ARI-0001<\/strong> as a medicine is one of the final steps in a long process that has been carried out entirely by the Hospital Cl\u00ednic Group.<\/p>\n

First, the new drug was developed using a proprietary antibody created at the Hospital Cl\u00ednic more than thirty years ago, and which has now been given a new application. Once ARI-0001<\/strong> was seen to be capable of controlling the disease in animal models, it was time for a clinical trial with patients. This got under way in July 2017 and was led by Dr Julio Delgado<\/strong>, from the Hospital Cl\u00ednic’s Haematology Department, and Dr Susana Rives<\/strong>, from the Hematology<\/strong><\/a> Department of SJD Barcelona Children’s Hospital.<\/p>\n

The results of the study showed that CAR-T ARI-0001<\/strong> induces a complete response in over 70% of patients, meaning there is no residual disease. Dr \u00c1lvaro Urbano-Ispizua<\/strong>, Director of the Clinical Institute of Haemato-Oncological Diseases<\/a>, explains that \u201cour CAR-T is safe and highly effective, with results comparable to those reported for other CAR-T therapies. Thanks to this therapy, we have been able to cover an unmet need for the treatment of patients with acute lymphoblastic leukaemia, specifically adult patients who are refractory to the available treatments and for whom there was no other option\u201d<\/em>.<\/p>\n

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\"Alvaro\u201cOur CAR-T is safe and highly effective, with results comparable to those reported for other CAR-T therapies. Thanks to this therapy, we have been able to cover an unmet need for the treatment of patients with acute lymphoblastic leukaemia, specifically adult patients who are refractory to the available treatments and for whom there was no other option\u201d<\/em><\/h4>\n

Dr\u00a0\u00c1lvaro Urbano-Ispizua<\/strong>, Director of the\u00a0Clinical Institute of Haemato-Oncological Diseases<\/a><\/p><\/blockquote>\n

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Image: Francisco Avia<\/small><\/strong><\/em><\/p>\n

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ASK FOR AN APPOINTMENT<\/a>\u00a0|\u00a0ASK FOR A TELEVISIT<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

In recent years, cancer treatment has been revolutionised by immunotherapy, an approach that uses a patient’s own immune system to attack tumour cells. The Spanish Agency of Medicines and Medical Devices (AEMPS) has just approved ARI-0001, a CAR T-cell therapy (a type of immunotherapy) developed entirely by the Hospital Cl\u00ednic Group, for use as a […]<\/p>\n","protected":false},"author":2,"featured_media":1932,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[84],"tags":[835,836,585,837,838,839,772,840,841],"class_list":["post-1949","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized","tag-hemato-oncological-diseases","tag-hematology","tag-hospital-clinic-group","tag-immunotherapy","tag-leukemia","tag-lymphoblastic-leukemia","tag-oncology","tag-treatment-of-leukemia","tag-treatment-of-lymphoblastic-leukemia"],"yoast_head":"\nThe AEMPS approves the use of a CAR-T therapy developed by the Hospital Cl\u00ednic Group for the treatment of a type of leukaemia - Blog barnacl\u00ednic+<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.barnaclinic.com\/blog\/en\/blog\/car-t-leukaemia\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"The AEMPS approves the use of a CAR-T therapy developed by the Hospital Cl\u00ednic Group for the treatment of a type of leukaemia - Blog barnacl\u00ednic+\" \/>\n<meta property=\"og:description\" content=\"In recent years, cancer treatment has been revolutionised by immunotherapy, an approach that uses a patient’s own immune system to attack tumour cells. 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