IrsiCaixa Cumple 25 Años Investigando : De la Pandemia del SIDA a la del Coronavirus .
CAMBIO DE DISCURSO : ADIÓS A LA SEGUNDA LÍNEA SCLC-ES EN EEUU Y EN EU ...CAMBIAMOS DISCURSO A MANTENIMIENTO EN FIRTS-LINE ///.... PERO PARA MANTENIMIENTO DE 1a LÍNEA APARECE UN MUY SERIO COMPETIDOR DEL IMFORTE : TARLATAMAB + DURVALUMAB /// IMFORTE EN EU DE UN TAM DE 600 MILLONES A UN MERCADO REAL MUCHO MENOR QUE PODRÍA SER DE TAN SOLO UNOS 85 MILLONES /// 2 DE OCTUBRE DE 2028 ... ES LA FECHA PARA LA POSIBLE LLEGADA DE GENÉRICOS DE LURBINECTEDIN ...
30 noviembre 2020
Las Primeras Vacunas Contra el Covid Llegarán a los Hospitales Británicos en 8 Días .
Los directores de los hospitales del Servicio Nacional de Salud (NHS) han recibido una notificación comunicando la llegada de las primeras dosis en el plazo de diez días.
La vacuna será suministrada en primera instancia al personal sanitario, seguidos de los trabajadores en las residencias y de los mayores de ochenta años. ...
29 noviembre 2020
Tratamientos y Vacunas Contra el Coronavirus . Aquí Están las Últimas Novedades .
Coronavirus Treatments And Vaccines . Here Are The Latest Developments .
Peter Fimrite | on November 29, 2020
The microbial treasure hunt is not just to find a cure — which may not be possible — but to control the debilitating health problems caused by the coronavirus.
Major progress has been made this year. The antiviral drug remdesivir, produced in Foster City, has improved recovery times, and the steroid dexamethasone has cut the number of deaths in severely ill patients.
What follows is a list of some of the most promising medications and vaccines with ties to the Bay Area:
Antibodies and Immunity
• Mesenchymal stem cells / UCSF and UC Davis Medical Center:
UCSF Dr. Michael Matthay is leading a study of whether a kind of stem cell found in bone marrow can help critically ill patients with severe respiratory failure, known as ARDS. Matthay hopes the stem cells can help reduce the inflammation associated with some of ARDS’ most dire respiratory symptoms, and help patients’ lungs recover.
In all, 120 patients are being enrolled at UCSF Medical Center, Zuckerberg San Francisco General Hospital, the UC Davis Medical Center in Sacramento and hospitals in Oregon and Texas. He said the trial, which includes a small number of ARDS patients who don’t have COVID-19, should have results by summer or fall 2021. So far, 28 patients are enrolled in San Francisco.
• Lambda-interferon / Stanford University:
Stanford researchers completed their trial of lambda-interferon and found that it did not boost the immune system response to coronavirus infections.
“That trial did not find any difference in outcomes between the treatment and placebo,” said Yvonne Maldonado, chief of pediatric infectious diseases at Lucile Packard Children’s Hospital at Stanford, where 120 patients were enrolled in the trial. “It didn’t work.”
Antiviral drugs
• Remdesivir / Gilead Sciences (Foster City):
Remdesivir, once conceived as a potential treatment for Ebola, was approved by the Food and Drug Administration in October for use on hospitalized COVID-19 patients.
Trademarked under the name Veklury, the drug interferes with the process through which the virus replicates itself. It was one of the drugs given to President Trump and has been used regularly in hospitals under what is known as an emergency use authorization.
It was approved after three clinical trials showed hospitalized coronavirus patients who received remdesivir recovered five days faster on average than those who received a placebo. Patients who required oxygen recovered seven days faster, according to the studies.
Gilead now plans to conduct clinical trials to see how remdesivir works on pediatric patients, from newborns to teenagers, with moderate to severe COVID-19 symptoms. Remdesivir is also being studied with steroids and other drugs to see if it works better as part of a medicinal cocktail. An inhalable form of the drug is also being developed.
Nurse Olivia Rocha, prepares to take the temperature of Betty Talton, who is also taking a new tool against coronavirus, remdesivir, in University Hospital Covid Unit, on Tuesday, June, 2, 2020.
• Favipiravir / Fujifilm Toyama Chemical (Stanford University):
Stanford epidemiologists are testing favipiravir to see if it prevents the coronavirus from replicating in human cells, halts the shedding of the virus and reduces the severity of infection. Unlike remdesivir, it can be administered orally, so it can be used to treat patients early in the disease, before hospitalization is necessary.
The Stanford study has so far enrolled about 90 patients, who are given the drug within 72 hours of when they were first diagnosed with COVID-19. Half of them get a placebo. People can enroll by emailing treatcovid@stanford.edu.
Monoclonal antibodies
REGN-COV2 / Regeneron Pharmaceuticals / Stanford School of Medicine:
The REGN-COV2 cocktail is the same one Trump received, and Stanford is one of dozens of locations nationwide where clinical trials are being held. Two separate trials are under way at Stanford — one for hospitalized patients, the other for outpatients. A third trial is about to begin for people who aren’t sick but are in contact with carriers of the virus.
Regeneron halted testing on severely ill patients requiring high-flow oxygen or mechanical ventilation after the independent Data and Safety Monitoring Board determined that the drug was unlikely to help them.
The drug is a combination of two monoclonal antibodies — lab-made clones of the antibodies produced naturally in people who have recovered from COVID-19. The antibodies bind to the virus’ spike protein and block the virus’ ability to enter cells.
Dr. Aruna Subramanian, professor of infectious diseases at Stanford and lead investigator for the inpatient trial, said the 21 hospitalized patients in the study receive a high dose like Trump, a lower dose or a placebo. Subramanian plans to expand the inpatient trial to 45 patients. The outpatient study has enrolled a little more than 40 of the 60 patients researchers intend to sign up.
“There’s enough promising evidence that it helps people early in the infection,” Subramanian said. “What we don’t know is whether it helps people who are pretty sick but not critically ill.”
• Bamlanivimab / Eli Lilly / Stanford and UCSF:
Dr. Andra Blomkalns, chair of emergency medicine at Stanford and the lead in the Eli Lilly outpatient trial, said she is now enrolling older people with comorbidities like heart disease, chronic lung disease, a history of strokes and severe obesity shortly after they test positive.
The hypothesis is that the bamlanivimab monotherapy, which is very similar to the Regeneron monoclonals, might work best early in the infection. Although about 400 patients have been enrolled in the Lilly phase 3 trials nationwide, to date fewer than 10 have been enrolled at Stanford and UCSF.
Matthay, who headed up the Lilly monoclonal study with LY-CoV555 at UCSF, said the cancellation of this inpatient trial was disappointing, but “just because this one did not work, doesn’t mean another one won’t work for hospitalized patients.”
Blomkalns said the testing criteria has been changing. She expects the outpatient trial to open soon to adolescents ages 12 and up to determine whether the drug can be used as a preventive.
• Designer monoclonal antibodies / Vir Biotechnology, San Francisco:
Scientists at Vir are studying several types of monoclonal antibodies, including a type engineered to activate T cells, which can search out and destroy cells infected with the coronavirus. A study published in the journal Nature in October found that monoclonals, modified to bind with certain receptors, stimulated T cells and improved the human immune response.
“By observing and learning from our body’s powerful natural defenses, we have discovered how to maximize the capacity of antibodies through the amplification of key characteristics that may enable more effective treatments for viral diseases,” said Herbert Virgin, the chief scientific officer at Vir and co-author of the study.
A similarly modified monoclonal antibody, leronlimab, is being studied in coronavirus clinical trials by its Washington state drugmaker, CytoDyn, which has developed drugs to treat HIV. The company’s chief medical officer is in San Francisco, and the company that does laboratory tests of leronlimab is in San Carlos.
Anti-inflammatory drugs
• Colchicine / UCSF (San Francisco and New York):
The anti-inflammatory drug commonly used to treat gout flare-ups is being studied by scientists at UCSF and New York University. The drug short-circuits inflammation by decreasing the body’s production of certain proteins, and researchers hope that it will reduce lung complications and prevent deaths from COVID-19.
Preliminary results from a clinical trial found that “Colchicine can be effective in reducing systemic symptoms of COVID-19 by inhibiting inflammatory biomarkers.”
• Selinexor / Kaiser Permanente:
Kaiser hospitals in San Francisco, Oakland and Sacramento are studying selinexor, an anticancer drug that blocks a key protein in the cellular machinery for DNA processing. Preliminary findings during the trials indicated that low doses of selinexor helped hospitalized patients with severe COVID-19. The drug has both antiviral and anti-inflammatory properties, and it’s administered orally, according to Kaiser’s Dr. Jacek Skarbinski.
Vaccines
• VXA-COV2-1 / Vaxart, South San Francisco:
“It’s the only vaccine (candidate) that activates the first line of defense, which is the mucosa,” said Andrei Floroiu, Vaxart’s chief executive. He said intravenous vaccines kill the virus after it is inside the body, but this one stops it beforehand.
The drug, which is effective against influenza and norovirus, induced both neutralizing antibodies and T cells during coronavirus drug trials, according to preliminary trial results published in September.
• VaxiPatch / Verndari (Napa and UC Davis Medical Center):
A Napa company, Verndari, is studying vaccines for COVID-19 that can be delivered using an adhesive patch. Researchers at UC Davis Medical Center in Sacramento said the patch caused an immune response in preclinical tests.
An October report in the online journal ScienceDirect touted the system, saying it “could serve as a ‘shelter in place’ vaccination strategy, in which vulnerable populations receive delivery at home without needing to engage an already-overtaxed health care infrastructure.”
If the vaccine is proven effective and safe, patients could receive it through the mail, according to Dr. Daniel Henderson, Verndari’s chief executive officer.
• ChAdOx1 / AstraZeneca (UCSF, San Francisco General Hospital, Bridge HIV):
Enrollment is under way at 80 sites in the United States, including three in the Bay Area, for the phase 3 trial of AstraZeneca’s vaccine, developed by Oxford University from an adenovirus, which typically causes colds in chimpanzees.
At least 1,000 of the 40,000 participants in the phase 3 AstraZeneca trial will be from the Bay Area, including 500 at Sutter Health’s East Bay AIDS Center in Oakland, 250 at Zuckerberg San Francisco General Hospital and another 250 at Bridge HIV San Francisco.
An interim analysis of trials in Britain and Brazil showed the vaccine was 90% effective in preventing COVID-19 in 131 patients who got a half-dose of the vaccine by mistake. The vaccine was only 62% effective in people who got a full dose, leading to major questions about the results and how the trial was conducted.
Bay Area trial leaders Dr. Annie Luetkemeyer of UCSF and Dr. Susan Buchbinder, director of Bridge HIV and a UCSF professor of medicine and epidemiology, are hoping future trial results are more clear. That’s because AstraZeneca’s vaccine is cheaper than those made by its rivals Pfizer and Moderna, whose vaccines were 95% and 94.5% effective in preliminary tests.
The AstraZeneca candidate can also be stored at temperatures between 36 and 46 degrees Fahrenheit, which is orders of magnitude higher than the Pfizer and Moderna vaccines. The Pfizer and Moderna vaccines must be kept at 94 degrees below zero Fahrenheit, colder than many storage facilities can manage.
• Johnson & Johnson (Stanford University)
The vaccine is, like the AstraZeneca version, a chimpanzee adenovirus that was genetically altered so that it carries the RNA of the coronavirus spike protein. The technique inspires the body to produce antibodies that block the protein without causing people to get sick.
“Phase 2 studies show that it produces a good immune response and the early results of phase 3 show that it’s safe,” said Dr. Philip Grant, assistant professor of infectious disease at Stanford and leader of the trial.
Grant, who is enrolling about 15 people a day for the trial, said he doesn’t expect results on the vaccine’s effectiveness until sometime in March.
Dr. Carballo Comunica un Inminente Nuevo Ensayo Clínico en su Hospital con una Sola Dosis de 8 MG ... Tiene que Tratarse de una Nueva Fase I-II ... Ya Que el ensayo De Fase I-II Recién Terminado No se Realizó con esa Dosi ... Se Realizó con Tres Dosis : 1,5 MG , 2 MG y 2,5 MG .
28 noviembre 2020
Adolfo Garcia Sastre Ratifica Que Aplidin Ha Obtenido unos Prometedores Resultados en la Fase I-II . Lo Que Toca Ahora es Demostrar su Eficacia y Seguridad en la Fase III . Ana Fernandez Sesma : Antes Que Aplidin Yo me Pondría Primero la Vacuna Ya Que las Vacunas Sirven para Prevenir las Enfermedades ... Cualquiera de Ellas Siempre Que Este Aprobada Por un Organismo Oficial o Agencia Sanitaria .
*.- Primero a Nivel de sus Respectivos Laboratorios ... Luego con los Resultados Obtenidos con los 27 Pacientes Tratados en la Fase I-II .
*.- Ahora Toca Elaborar un Articulo Científico con los Resultados Obtenidos en Dicha Fase I-II y Que Algúna Revista Científica de Renombre pueda Publicarlos .
*.- Mientras Ya se Trabaja en el Diseño del Ensayo de Fase III Que Tal y Como Ya Adelanto Fernández Sousa Se llevará a Cabo en Varios Países .
*.- Insiste en Que es una Lástima Que no Se Pueda Administrar de Forma Oral ... Fernandez Sousa Ya Dijo al Respecto Que Esa Idea Estaba Encima de la Mesa Pero Que Por Parte de la Administración No Había Obtenido Ningún Apoyo .
*.- Sastre Concluye Conque Aplidin Pinta Bien ... Pero Aún le Faltan Datos a Demostrar y Eso se Demuestra Realizando una Fase III y en Ello Están .
*.- Uno de los Posibles Problemas en Que se Pueden Encontrar ( a Parte de la Posible Vacunación a Nivel Mundial ) ... Es Que con el Paso de los Días el Numero de Infectados se Redujera Tal y Como Está Ocurriendo Ya en Varios Paises Asiaticos .
*.- Le Preguntan : ¿ Si Usted Mismo se Infectara con el Virus ... se Trataría con Aplidin ?
Sastre : Si Yo me Infectara y Estuviera el Fármaco Aprobado y Siempre Bajo la Prescripción de Mi Medico ... ¡¡¡ Si Me Trataría con Aplidin !!! .
*.- ¡¡¡ Conste Que No Tenemos Acciones de PharmaMar !!! .
*.- Con Más Ensayos Sabremos Donde Puede Encajar Aplidin Y a Que Grupo de Pacientes Puede Ayudar ... Según Carga Viral ... Grupo de Riesgo ... Desarrollo de la Enfermedad ... Todo un Encaje Que la Fase III Tendra Que Demostrar .
*.- Tambien Creo Que Aplidin Podría Valer Para Otros Tipos de Virus ...
*.- Antes Que Aplidin Yo Primero Me Pondría la Vacuna Porque la Vacuna Previene La Enfermedad Mientras Aplidin Serviría Para Tratar la Enfermedad .
*.- Cualquiera Vacuna me Vale Mientras Este Avalada y Aprobada Por un Organismo Oficial y Agencia Sanitaria .
27 noviembre 2020
26 noviembre 2020
AstraZeneca Evalúa Realizar Otro Ensayo Global de Vacuna COVID19 . Reconoce Error en Desarrollo de su Vacuna Contra Covid-19 ( By Bloomberg ) . Se están Realizando Ensayos con las Vacunas Como Si Fuera Algo Muy Sencillo y Rápido de Realizar . Y Tenemos un Buen Ejemplo de Que No es Así : En 40 Años Aún No ha Dado NINGUNA FARMA CON UNA VACUNA PARA EL SIDA
25 noviembre 2020
Jose María Fernandez Sousa Sobre APLIDIN tanto Oncologico como AntiViral . En Corea Boryung en Cualquier Momento Iniciara sus Ensayos Clinicos .
*.- Aprobado en Australia .
*. En Evaluación en algún Pais más .
*.- En Europa tras Haber Ganado el Pleito a la EMA y Haberse Suspendido la Negativa de la EMA ... el Reloj Vuelve a Cero .
Aplidin AntiViral :
*.- Inhibe al Virus del Covid ( EF1a ) .
*.- En Acuicultura ... los Virus son un Gran Problema ... Salmones , Langostinos , Ostras , Invetebrados ... es por ello que muchos han desarrollado defensas frente a los Virus ...
*.- En la Fase I se han Visto Altas a los 8 Días de Ingreso y ser Tratado con Aplidin .
*.- Los resultados de dicho Ensayo se Publicarán en Revista Cientifica .
*.- Se esta Diseñando la Fase III que se realizara en varios paises y en Cuánto este todo listo para empezar ... se comunicara .
*.- Tambien se Testara en otros tipos de Virus RNA .
*.- Con Las Vacunas hay que ir Partido a Partido ... y ya se vera si algúna convence para que nos la Pongamos .
*.- Hemos tenido poca Colaboración de las Entidades Publicas ... este año nos han denegado todas las Ayudas que hemos pedido ... incluido un proyecto para que Aplidin pudiera ser administrado de Forma Oral .
*.- Una diferencia Abismal entre lo que ocurre aqui en España y lo que ocurre en Estados Undidos en relación al Apoyo a la I+D de sus empresas .
*.- Aqui en España ni son Ayudas ... son Prestamos ... Una Tomadura de Pelo . Aqui no nos han ayudado ... nos han Perjudicado .
*.- ¡¡¡ Estamos en un Estado de Entropía !!! .
*.- Lo peor ya ha Pasado ... ahora iremos rapido con ensayos de Fase III en varios Países . Preparando ya el Protocolo de dicho ensayo .
*.- Iremos solos en la I+D .
*.- Si llegara la aprobacion en EEUU ... entonces si buscaríamos licenciar a una CIA Americana para que la Vendan ellos en ese País ... ya que nosotros ahí no tenemos Red de Ventas .
*.- En Corea Cualquier Día Iniciarán sus Ensayos Clinicos ...
*.- Uso Compasivo depende de un médico que considere que Aplidin pueda ser la solución para su Paciente y debe solicitarlo a la Agencia Española del Medicamento .
*.- Nos estan Llamando desde Varios Paises del Mundo interesados en poder realizar el Ensayo Clinico en su Pais .
*.- El Único Problema que puede Haber es que pase esta Ola y volvamos a encontrarnos con pocos Pacientes ... la ventaja es que al realizar el ensayo en varios Países tendremos capacidad de reclutamiento ( esperamos ) .
*.- En el Mar seguro que hay Muy buenos Antivirales ... de ahí que hemos Creado una Unidad de I+D AntiViral .
Esta Vacuna Contra el Cáncer es un Misil Dirigido Hacia el Tumor : 90% de Efectividad . La Vacuna se Encuentra Ya Lista Para Empezar el Estudio en Fase 1 Para Humanos .
Este Tratamiento se Administra en una Dosis en Combinación con un Medicamento para la Inmunoterapia.
Esta Nueva Vacuna se ha Usado Para Combatir el Cáncer de Colón Dando Resultados Satisfactorios en 9 de Cada 10 Animales.
Los Próximos en Testar la Vacuna Serán Pacientes Australianos con Cáncer de Pulmón. ...
24 noviembre 2020
Bamlanivimab By Eli Lilly . Is How The First Specific Drug Against COVID19 Works .
Bamlanivimab Has Already Been Endorsed By The FDA .
November 24, 2020 .
By Francisco Lopez-Muñoz , Camilo José© Cela University and Jose Antonio Guerra Guirao , Complutense University of Madrid .
This therapeutic agent, developed by the pharmaceutical company Eli Lilly, is a monoclonal antibody similar to those that were part of the cocktail of drugs for COVID-19 that was administered to Donald Trump.
What are monoclonal antibodies?
In general, antibodies are large proteins that make up the immune system necessary to identify and neutralize foreign objects in the body, such as bacteria and viruses.
In the specific case of monoclonal antibodies (mAbs, monoclonal antibodies ), these are glycoproteins produced by the clone of a hybrid cell (created from the fusion of a single stem cell of the immune system and a tumor plasma cell) and designed to attack a specific antigen.
Its production is based on the establishment of immortal B lymphocytes modified to produce a specific immunoglobulin. Depending on the level of purity of the immunoglobulin, it can be completely murine, chimeric, humanized or completely human.
Monoclonal antibodies are carefully selected and directed against a specific molecule that plays a key role in a disease process, and they are often used to treat certain diseases such as cancer or rheumatoid arthritis.
What About Neutralizing Antibodies?
Neutralizing antibodies are one of the possible defenses of the immune system against infections.
These antibodies make it possible to counteract and eliminate the effect of invading microorganisms, and their activity is triggered, for example, by proteins located on the surface of viruses, to which they bind to "block" the infection .
In this sense, the scientific community has been studying for some time whether the defensive response through neutralizing antibodies can induce effective and lasting immunity. And, more specifically, it is investigating whether the antibodies generated by patients who have been in contact with the SARS-CoV-2 coronavirus could be used as the basis for new treatments for covid-19 .
However, although neutralizing antibodies are generated when a person suffers an infection and seem to play an important role in the immune response, their specific role in the covid-19 gears has not been fully elucidated.
The studies carried out so far with the SARS-CoV-2 virus indicate that neutralizing antibodies appear about two weeks after beginning the infection, and that their maximum peak of activity would be between weeks 4 and 6. But there are still many unknowns: it has not been confirmed whether all infected patients generate neutralizing antibodies; what factors determine its appearance and activity (age of the patient, severity of infection). Nor if their neutralization levels are always sufficient to confer protection, since these levels are highly variable and are not detected in 10-30% of patients.
The entry of SARS-CoV-2 into cells is initiated by the interaction of the receptor-binding domain (RBD) of the viral Spike (S) glycoprotein with the angiotensin-converting enzyme-2 (ACE2), which acts as a receptor for the virus on the surface of the target cell. The most potent neutralizing mAbs target RBD, and some may act simply by competing with the receptor to bind to protein S.
What is bamlanivimab?
This agent is licensed for the treatment of patients with positive SARS-CoV-2 test results who are 12 years of age or older and weigh at least 40 kilograms and who are at high risk of progressing to severe COVID-19 or hospitalization. . This includes those patients who are 65 years of age or older, or who have certain chronic medical conditions. Bamlanivimab is a drug that must be applied intravenously, so patients must go to a hospital for it to be administered.
While the safety and efficacy of this investigational therapy continues to be evaluated, clinical trials have confirmed that bamlanivimab, compared to placebo, reduces covid-19-related hospitalizations or emergency room visits in patients at high risk of disease progression, within 28 days after starting treatment . For this reason, its use is recommended in the early stages of the disease, preferably in the first 10 days after the onset of symptoms of the disease.
However, Bamlanivimab is not authorized in the case of patients hospitalized for COVID-19 or who require oxygen therapy, since a significant benefit of treatment with this monoclonal antibody has not been demonstrated in hospitalized patients with COVID-19. And indeed, mAbs, such as bamlanivimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 who require high flow oxygen or mechanical ventilation.
With regard to the safety profile, the adverse effects of mAbs , in general, can be grouped into two different types: those derived from the action of the antibody, such as opportunistic infections, common infections or development of autoimmune phenomena; and those derived from the administration of proteins: anaphylactic reactions, cytokine release syndrome and development of antibodies. In the specific case of bamlanivimab, the adverse reactions most frequently reported to the FDA have been nausea, dizziness, headache, pruritus, non-severe immediate hypersensitivity, diarrhea, and vomiting.
In Conclusion
However, the pharmaceutical company responsible for the development, Eli Lilly, must commit to providing more clinical data to supplement the information on the efficacy and safety of the medicine, as the results of ongoing clinical trials are obtained. And only when these data are positive would full and definitive authorization be granted, while, otherwise, the drug would have to be withdrawn from the market.
Bamlanivimab opens a new and promising window in the therapy of covid-19, therefore, unlike other drugs available on the market for other diseases and which have shown some efficacy in this pathology ( Remdesivir , Plitidepsin , Dexamethasone , Hydroxychloroquine , etc.), this is the first medicine specifically developed and authorized for the treatment of covid-19 patients.
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