{"id":3556,"date":"2022-02-18T11:37:08","date_gmt":"2022-02-18T11:37:08","guid":{"rendered":"https:\/\/www.barnaclinic.com\/blog\/?p=3556"},"modified":"2022-04-28T16:48:29","modified_gmt":"2022-04-28T16:48:29","slug":"car-t-ari-0001-prime-designation-ema","status":"publish","type":"post","link":"https:\/\/www.barnaclinic.com\/blog\/en\/blog\/car-t-ari-0001-prime-designation-ema\/","title":{"rendered":"The CAR-T ARI-0001 developed by the Hospital Cl\u00ednic obtains the PRIME designation from the European Medicines Agency"},"content":{"rendered":"

ARI-0001<\/strong><\/a> is a CAR-T therapy<\/strong><\/a> that has been developed at Hospital Cl\u00ednic for the treatment of acute lymphoblastic leukaemia. In February 2021, the Spanish Agency for Medicines and Health Products (AEMPS) approved its use<\/a> and it became the first treatment with genetically modified cells and fully developed in Europe that was approved by a regulatory agency<\/strong>. The path of ARI-0001<\/strong> has not stopped here, and now the European Medicines Agency (EMA)<\/strong><\/a> has granted it the<\/strong> PRIME designation<\/strong><\/a>, which means that it has become a priority for the agency thus offering its support for an evaluation acceleration of this therapy.<\/p>\n

<\/p>\n

The Hospital Cl\u00ednic also becomes the first academic institution to obtain this designation from the EMA<\/strong>. \u201cOnly 25% of the applications to obtain this PRIME designation are successful, including pharmaceutical companies and academic institutions\u201d, explained Dr Julio Delgado<\/strong>, coordinating haematologist of the multidisciplinary immunotherapy<\/strong><\/a> program at Hospital Cl\u00ednic. \u201cThis is a complex process, because until now, only four academic institutions had applied for the PRIME designation, all of them denied. Cancer immunotherapy<\/strong><\/a> is a cornerstone of Hospital Cl\u00ednic\u2019s commitment to researching new therapeutic possibilities for patients with limited options\u201d, adds Dr Delgado.<\/p>\n

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IT MAY INTEREST YOU\u2026<\/h4>\n

–<\/em> 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<\/a><\/h4>\n<\/div>\n

THE CAR-T ARI-0001 THERAPY, A PRIORITY FOR THE EMA<\/h2>\n

The development of new therapies is a long and complex process. Many treatments fall by the wayside and others see their arrival in clinical practice delayed for years. In cases of pathologies where there are no alternatives, this is a serious detriment for patients. With all this in mind, the EMA launched its PRIME program to cover precisely these unmet needs.<\/p>\n

This voluntary scheme is based on better interaction and early dialogue with institutions developing promising medicines, to optimize development plans and accelerate evaluation so that these medicines can reach patients as soon as possible.<\/p>\n

\u201cThere was no approved CAR-T therapy<\/strong><\/a> for patients older than 25 years with ALL resistant to conventional treatments. The CAR-T ARI-0001<\/strong><\/a> covers this therapeutic need. Hence the interest of the EMA\u201d, points out Dr \u00c1lvaro Urbano-Ispiz\u00faa<\/strong><\/a>, director of the Institute of Hematological and Oncological Diseases (ICMHO)<\/a>. \u201cIt is an important first step that will allow us to work so that patients can benefit as soon as possible from therapies that can significantly improve their quality of life\u201d, he says.<\/p>\n

\n

\"Alvaro<\/h4>\n

\u201cThere was no approved CAR-T therapy<\/strong><\/a> for patients older than 25 years with ALL resistant to conventional treatments. The CAR-T ARI-0001<\/strong><\/a> covers this therapeutic need. Hence the interest of the EMA\u201d<\/h4>\n

Dr \u00c1lvaro Urbano-Ispiz\u00faa<\/strong><\/a>, director of the Institute of Hematological and Oncological Diseases (ICMHO)<\/a> of the Hospital Cl\u00ednic de Barcelona<\/p><\/blockquote>\n

CAR-T, A PERSONALISED THERAPY<\/h2>\n

The therapies called CAR-T are one of the most personalised drugs that exist in the treatment of cancer. In a first phase, T lymphocytes, white blood cells that are responsible for the immune response, are extracted from the patient\u2019s blood. Later, in the laboratory, these T lymphocytes are genetically reprogrammed and, finally, reintroduced into the patient so that they can recognize and attack tumour cells, without damaging healthy ones.<\/p>\n

As it is a drug that is tailored to each patient, this means that its cost is high \u2013 exceeding 300.000 euros per patient in the United States \u2013 and poses a challenge for many health systems. The version that has been developed by the Hospital Cl\u00ednic Group manages to reduce its cost enormously, becoming substantially cheaper.<\/p>\n

COMPLETE RESPONSE IN MORE THAN 70% OF PATIENTS<\/h2>\n

In the case of CAR-T ARI-0001<\/strong><\/a>, the development started from an antibody created in the hospital more than 30 years ago, for which a new application was found. T lymphocytes, responsible for the immune response, are obtained through apheresis. These are genetically reprogrammed so that, when transfused back into the patient, they can specifically recognize tumour cells and attack them. After three weeks, the response in the patient can already be observed.<\/p>\n

To assess its efficacy, a clinical trial was carried out between 2017 and 2019, led by Dr Julio Delgado<\/strong>, from the Hematology<\/strong><\/a> Service of Hospital Cl\u00ednic and Dr Susana<\/strong> Rives<\/strong>, from the Hematology Service of Hospital Sant Joan de D\u00e9u de Barcelona. The study included 58 adult and paediatric patients. Of these, 38 with ALL were treated with the CAR-T developed at the Cl\u00ednic<\/strong>. All patients had received several lines of treatment and the vast majority had received bone marrow transplantation. Therefore, these were patients without available therapeutic alternatives. The results showed that CAR-T ARI-0001<\/strong> produced a complete response in more than 70% of patients, leaving no residual disease.<\/p>\n

In addition to ARI-0001, the Hospital Cl\u00ednic is working on the development of other therapies of this type, such as ARI-0002h, <\/strong>for patients with multiple myeloma resistant to standard treatments<\/a> and which has already shown that it is capable of achieving a rate of response of up to 75% after one year of treatment and that 60% of patients have a complete remission and without residual disease.<\/p>\n

\n

IT MAY INTEREST YOU\u2026<\/h4>\n

–<\/em> The Hospital Cl\u00ednic Group develops a second CAR-T, suitable for multiple myeloma resistant to treatment<\/a><\/h4>\n<\/div>\n

A CAR-T UNIT OF EXCELLENCE<\/h2>\n

The CAR-T Unit<\/a> of the Hospital Cl\u00ednic Group is a multidisciplinary team that brings together more than 180 professionals, including haematologists, pharmacologists, neurologists, intensivists and immunologists, among others. Since it was put into operation more than 10 years ago, more than one hundred patients have already been treated in this unit with its own products, such as the CAR-T ARI-0001<\/strong><\/a>\u00a0therapy<\/strong>, but also many others with other commercial products.<\/p>\n

It is currently one of the centres authorised by the National Health System for the commercial administration of CAR-T products (it is the one that obtained the highest score of all authorised centres), and is currently accredited for the administration of the two available commercial CARTs (Yescarta from Kite-Gilead and Kymriah from Novartis). These accreditations have enabled the centre to treat patients with diffuse large B-cell lymphomas, primary mediastinal lymphomas, transformed follicular lymphomas, and acute lymphoblastic leukaemia within an approved CAR-T treatment program.<\/p>\n

\n

IT MAY INTEREST YOU\u2026<\/h4>\n

–<\/em> CAR-T PROGRAM AT BARNACL\u00cdNIC+<\/a><\/h4>\n<\/div>\n

One of the main goals pursued with the CAR-T Unit<\/a>\u00a0is to bring this treatment closer to patients who had few therapeutic options, thus expanding the options for treating tumours and thus offering patients good treatment alternatives. With the award of the PRIME designation, this goal will be a little closer.<\/p>\n

\n
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DO YOU WANT TO CONTACT OUR HEMATOLOGY SERVICE OR DO YOU WANT INFORMATION ABOUT OUR CAR-T PROGRAM?<\/span><\/h4>\n

ASK FOR A FACE-TO-FACE APPOINTMENT<\/a> |\u00a0ASK FOR TELEVISIT<\/a><\/p>\n<\/div>\n

\n

Image: Hospital Cl\u00ednic<\/small><\/strong><\/em><\/p>\n","protected":false},"excerpt":{"rendered":"

ARI-0001 is a CAR-T therapy that has been developed at Hospital Cl\u00ednic for the treatment of acute lymphoblastic leukaemia. In February 2021, the Spanish Agency for Medicines and Health Products (AEMPS) approved its use and it became the first treatment with genetically modified cells and fully developed in Europe that was approved by a regulatory […]<\/p>\n","protected":false},"author":2,"featured_media":3411,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1082,1050,526,1129],"tags":[1400,1401,1226,1399,1402,1403,836,1398,1225,772],"class_list":["post-3556","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-haematology","category-hematology","category-medical-oncology","category-oncology-surgery","tag-ari-001-en","tag-car-t-en","tag-car-t-therapy","tag-car-t-unit","tag-dr-alvaro-urbano-en","tag-dr-julio-delgado-en","tag-hematology","tag-immunology","tag-onco-hematology","tag-oncology"],"yoast_head":"\nThe CAR-T ARI-0001 obtains the PRIME designation from the EMA<\/title>\n<meta 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