Arranca el primer ensayo clínico en España con una innovadora terapia celular contra el cáncer

El Vall d’Hebron Instituto de Oncología (VHIO), que forma parte del Campus Vall d’Hebron, acaba de recibir la autorización de la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) para poner en marcha el primer ensayo clínico con células TIL (por sus siglas en inglés, Tumour-infiltrating Lymphocytes) de España, que se han seleccionado según su reconocimiento de neoantígenos derivados de mutaciones detectadas a través de la secuenciación del tumor. Esos linfocitos, que se encuentran de manera natural en el tumor, se reactivan en el laboratorio en presencia de interleuquina 2 (IL-2) para reactivar su capacidad de reconocer las células tumorales y destruirlas.

Al obtener una biopsia tumoral, el tumor se corta en pequeños fragmentos que se cultivan en IL-2 para favorecer la expansión de los linfocitos T infiltrantes. Posteriormente, se realiza un cribaje personalizado en el laboratorio para ver qué linfocitos T reconocen mutaciones que son únicas de las células tumorales o neoantígenos. A partir de aquí, se seleccionan los TIL que reconocen neoantígenos y se expanden en el laboratorio para luego volver a administrárselos al paciente.

“En definitiva, se trata de crear un ejército de células del propio paciente que nos ayude a atacar de forma más eficaz al tumor”, explica la Dra. Alena Gros, investigadora principal del Grupo de Inmunoterapia e Inmunología de VHIO, que ha liderado el desarrollo preclínico de esta terapia.

El equipo de la Dra. Alena Gros, gracias al apoyo del Programa Integral de Inmunoterapia e Inmunología (CAIMI) impulsado por la Fundación BBVA, lleva años investigando las respuestas antitumorales producidas de forma natural por las células T contra mutaciones que ocurren en diferentes tipos de tumores, entre ellos los cánceres endometriales y otros tumores epiteliales no resecables.

Los datos obtenidos por la Dra. Gros han demostrado que los tumores están infiltrados de forma variable por diferentes tipos de células inmunitarias o TIL, como pueden ser CD4+, CD8+, entre otras, y que la expresión de la proteína PD-1 en los linfocitos puede ayudar a identificar aquellos que son más reactivos al tumor. El ensayo clínico actual, basado en la administración de linfocitos específicos de neoantígenos, es una primera aproximación para tratar a pacientes con cáncer. Los datos indican que los TIL específicos de neoantígenos son más seguros y deberían ser más potentes eliminando los tumores. En el futuro también se prevé desarrollar productos de TIL seleccionados a partir de distintos biomarcadores que son capaces de distinguir los linfocitos reactivos del tumor, incluso a partir de sangre periférica.

En el ensayo clínico que se inicia ahora, financiado por el ISCIII, participarán diez pacientes, a los que se les subministrará la terapia celular con TIL combinada con una quimioterapia y un factor de crecimiento de linfocitos T (interleuquina 2, IL-2). Su objetivo es determinar si la terapia con TIL es segura y si puede ser una alternativa terapéutica para pacientes que no responden a otros tratamientos. La Dra. Elena Garralda, investigadora principal de este ensayo y directora de la Unidad de Investigación de Terapia Molecular contra el Cáncer (UITM) – CaixaResearch, comenta que

“la terapia con TIL es una terapia altamente personalizada que ha dado resultados en pacientes con melanoma metastásico, pero que todavía no tiene una elevada eficacia demostrada en otros tipos de tumores sólidos. Aunque la previsión es que no todos los pacientes responderán a esta terapia con TIL, este estudio nos permitirá entender mejor cómo funciona esta terapia para poder seleccionar mejor a aquellos pacientes que tienen más probabilidad de responder al tratamiento. Se trata de una terapia desarrollada íntegramente en VHIO y para mi equipo es un privilegio poder iniciar el ensayo clínico en pacientes después de tantos años de trabajo”, añade la Dra. Garralda.

Este proyecto ha requerido la formación y el trabajo coordinado de un gran equipo multidisciplinario, integrado por profesionales de diferentes ámbitos en la gestión e investigación de VHIO (Desarrollo Clínico Precoz, Grupo de Inmunología e Inmunoterapia del Cáncer, Área de Coordinación Científica, Clinical Research Office-CRO-Académica) y el Banc de Sang i Teixits (BST), para poder validar esta técnica para su uso clínico. El trabajo ha incluido importantes aspectos regulatorios, complejos y novedosos, que han permitido llegar a la fase del ensayo clínico con pacientes.

2 opiniones en “Arranca el primer ensayo clínico en España con una innovadora terapia celular contra el cáncer”

  1. Good day!

    We are sending via contact forms to the sites of companies via any countries and domain zones of the world in all languages.

    website =» xn—-7sbb1bbndheurc1a.xn--p1ai

    WHAT IS THE MAILING OF SITES BY FEEDBACK FORMS?
    This is a type of mailing using the feedback forms that are located in the contact section of the website and filled by our robot in a preset mode with a rate of a few thousand feedback forms per 1 minute, while the alphanumeric code from the pictures (captcha) is also solved.
    After that, the correspondent e-mails including your offers are sent to the electronic addresses of businesses.
    When sending mailing by contact feedback forms, it turns out that each website sends a correspondent e-mail “to itself” and, therefore, all messages arrive in the inbox of the exact mailbox in which the business is ready to receive the commercial information.

    UTP:
    Fast 100% notification of firms and website owners about new commercial offers.
    Search of new customers that other advertisements cannot find.

    THE MAIN AIM:
    Finding customers that cannot be found through other types of advertisements.

    Benefits:
    1.one hundred % delivery of business letters.
    2.Increase of the client base.
    3. Expansion of the your market segment.
    4.Regionality and topic orientated mailings.
    5. Sending information to directors.
    6. Demand study.
    7. Conducting marketing research.
    8. Conducting surveys and studying public opinion.
    9. Fast notofication.
    10. Cost.
    11. Entering the international markets.

    Competitive advantages:
    1.When sending mailing by feedback forms, all e-mails arrive in the inbox folder. When sending e-mail newsletters, this can reach up to five percent.

    2.When sending mailing by feedback forms it is possible to send a few million letters per day to inbox folders. When sending e-newsletters a few thousands arrive in the inboxes, the remaining ones often either do not reach or fill the spam.

    3. When sending mailing by contact forms a letter does not get blocked by mails because it is sent from different sites. When sending e-mail newsletters it is possible to send a few thousands of those but nevertheless all the IP addresses from which the mailing is sent will be in «BAN».

    4. When sending mailing by contact forms the minimum of macro-synonims is used to form headings and text of the letter. When sending bulk e-mails, it is necessary to use synonyms («macros») for each phrase and create thousands various headings.

    5. A lot of organisations try to hide their e-mail and only leave a contact form for contacting with them.

    6. When sending mass e-mails, your cooperation offer can be delivered to every employee of the company, (which causes discontent) compared to mailing by feedback forms where the message is received at the mailbox specifically set up for commercial offers.

    7.1/2 part of business mailboxes are located on free mail servers, they are badly «searchable» by electronic address, but when sending mailing by feedback forms through these mail systems, all e-mails are one hundred percent delivered to the recipients.

    8. Only thirty-forty % of businesses get into the directories within 2-3 years, and the rest are already placed in our VOIS databases and are waiting for your commercial offers.
    It turns out that that emails of companies from directories are filled with spam, which means that they will not have such outcome as when sending mailing by contact forms using our new VOIS databases.

    9. Any kind of stop words in the body or headings of the letter can be sent through feedback forms. When sending e-mail newsletters, such messages either do not reach the recipient or end up in junk.
    The list of stop words of mail systems includes almost all words and phrases that encourage potential customers to take actions.

    Application:

    1. Searching for new clients.
    2. Quick informing of marketplaces about new business offers.
    3. Accessing directors.
    4.Supply.
    5. Conducting tenders.
    6.Conducting marketing research.
    7.Studying public opinion and conducting surveys.
    8. Searching for customers internationally.
    Reasons for purchasing this service:

    1. one hundred percent delivery of your e-mails and cooperation offers to millions of organisations around all countries in the world.
    Every internet resource sends a e-mail to itself so all filters of mail systems are bypassed.

    2.Mailing by contact forms is an ideal way in for conducting various researches of marketing, surveys and studies of social opinion on any kind ofdirection and type of activity.
    When sending mailing by feedback forms, you will will be absolutely sure that your message has been delivered to 100-percent of users of your product and service and if a service or product is «badly promoted», then the potential problem lies in in something else, for example in price.
    At the same time, within one week you will see demand for your products and services, you will not need to spend funds on rent and other more time-consuming and expensive marketing activities.

    3.Mailing by feedback forms is the most economical and quickest way to get your service or product to the markets of other countries.

    4. Mailing by contact forms is an excellent tool for conducting various tenders.

    5.Daily update of the databases, as more than 150,000 new Internet resources, appear all over the globe daily, and you, in turn, get potentially new customers.

    6. Full geographical scope for all countries of the globe.

    7. We offer customers that you will not find through other advertisement.
    When sending mailing by contact forms, you will be able to get to that part of your customers, that are impossible to find in automatic mode in any other way.
    For instance, you will be able to send a business offer to those potential customers that were earlier out of reach due to e-mail filters while sending e-mail newsletters.
    In reality, there is a unusual situation: businesses that got into the directories are completely spammed with all sorts of cooperation offers while very little e-mails are sent to the remaining ones.

    8. Unique technology of decoding the CAPTCHA.
    There are services for decrypting numeric and alphabetic code (captcha/CAPTCHA). It costs 1 dollar to solve thousand captchas.
    It turns out that, processing 1 million websites our robot decrypts 1 million CAPTCHAs, which costs 1000 $ only to decode captcha/CAPTCHA, and we provide this free of charge for you!

    9. By ordering mailing by contact forms, you are promoting your service or product not to separate people, but to collectives, for example domain .com, where more than 150 million commercial businesses from all over the world are collected (we have samples of them from international zones for every state).

    10. Mailing by contact forms also includes a type of text mailing
    Email that is linked to the feedback form is the main e-mail address of firms through which orders and cooperation offers are sent. This e-mail is also set up for cell phones as it is necessary to respond to the information very fast so as not to misplace the application or the relevance of the cooperation offer.

    11. The base of countries also includes all joint businesses from all countries closely related to or working with this country, for instance, diasporas and national communities.
    BAN, sanctions of mail systems and search engines?
    These mailings are an alternative to sending e-mail newsletters, therefore search engine sanctions and «BAN» do not apply to them.
    Mail delivers the data of letters to the inbox folder, as it goes through the «warm communication channel» from the new IP address of the website to the corporate electronic address of the same site.
    Simply speaking, these mailings «live in e-mails» and e-mail filters do not react to them, because mails have a great level of trust in communication channels between sites and corporate electronic addresses.

    OUR DATABASES:
    You can buy our databases separately from the mailing by sending us a message by feedback form.

    MORE THAN 2000 WHOIS DATABASES BY DOMAIN ZONES AND COUNTRIES OF THE WHOLE WORLD.

    COLLECTIONS OF DATABASES BY THE MAIN CONTINENTS OF THE WORLD.

    COLLECTIONS OF DATABASES BY THE MAIN LANGUAGES.

    SELECTIONS OF DATABASES BY THE MAIN CMS.

    SELECTIONS BY THE MAIN COUNTRIES OF THE WORLD.

    HOW TO MAKE AN ORDER FOR MAILING BY FEEDBACK FORMS:
    The simplest text + headings, the main goal is to interest the future customer, and they will read the rest on your site.
    Most likely, all ads on your subject are already on the Internet, enter the necessary requests into the search engine and choose the most suitable ones.
    The headings are substituted randomly from text file.
    Only messages in the text form are sent, links are inserted without problems, they are active. If the future customer needs pictures or more detailed information, then you should forward the client to visit your site.

    In the letter:
    Text without pictures, since pictures do not pass through the contact form.
    Your contact details:
    Website address:

    Fields to fill in:
    Name:
    Country:
    City:
    Site:
    Several headings:
    Email for automatic responces:

    website =» xn—-7sbb1bbndheurc1a.xn--p1ai
    Price List =» xn—-7sbb1bbndheurc1a.xn--p1ai/en/price/

Deja una respuesta

Tu dirección de correo electrónico no será publicada. Los campos obligatorios están marcados con *