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 isf35

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Denis
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Nombre de messages : 15772
Date d'inscription : 23/02/2005

MessageSujet: Re: isf35   Mer 10 Juil 2013 - 10:50

Pharmacyclics, Inc, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the investigational oral Bruton's tyrosine kinase inhibitor ibrutinib, for two relapsed/refractory B-cell malignancy indications: mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). The submission was based on data from phase II studies in patients with relapsed/refractory MCL and in patients with relapsed/refractory CLL/SLL.

[b]L'Ibrutinib, un inhbiteur de tyrosine Kinase a été sousmis à l'approbation de la FDA pour deux applications : pour le "lymphome de la cellule avec un manteau " (mantle celle lymphocytic lymphome et la SLL "le petit lymphome lymphocytique " (small lymphocytix lymphome)

With this submission, Pharmacyclics is also requesting Priority Review. If approved, ibrutinib would be the first available agent in a class of oral Bruton’s tyrosine kinase inhibitors. Pharmacyclics is jointly developing ibrutinib with Janssen.

Breakthrough Therapy Designations

The NDA submission follows the receipt of a Breakthrough Therapy designation from the FDA in February 2013 for ibrutinib as a monotherapy for the treatment of patients with relapsed/refractory MCL, and receipt of a second Breakthrough Therapy designation for the treatment of patients with CLL/SLL with deletion of the short arm of chromosome 17 (del 17p). Ibrutinib has also been granted a Breakthrough Therapy designation for the treatment of patients with Waldenström’s macroglobulinemia.

"We are very excited having achieved this major milestone. This first NDA for ibrutinib was made possible in record time because of the continuous support and consultations we received from the FDA," said Urte Gayko, PhD, Senior Vice President of Global Regulatory Affairs, Pharmacyclics. "We look forward to continuing to work with the FDA as they review the application for ibrutinib through the new Breakthrough Therapy designation process," he added.

"The FDA submission is another important milestone for ibrutinib since we formed our strategic partnership with Pharmacyclics just 18 months ago," said Peter F. Lebowitz, MD, PhD, Global Oncology Head, Janssen. "Both companies recognize that there is great unmet need among these patient populations, and together in close collaboration with the FDA, as part of its Breakthrough Therapy designation pathway, we have been able to accelerate the ibrutinib development program for the benefit of patients,” he said.

“Thus far, more than 1,600 patients have been treated in our studies with ibrutinib and we are making excellent progress in the development and preparation for commercialization of this investigational drug,” noted Bob Duggan, CEO and Chairman of Pharmacyclics. “As of today, we have initiated seven phase III studies together with our partner Janssen and have currently registered with the U.S. National Institute of Health 31 clinical trials using ibrutinib.”

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MessageSujet: Re: isf35   Jeu 20 Juin 2013 - 11:09

Le lymphome du manteau et ibrutinib

Les résultats de cette étude de phase II ont montré un taux de réponse global de 68 pour cent, avec 21 pour cent de patients obtenant une réponse complète et 47 pour cent obtention d'une réponse partielle. La survie globale estimée était de 58 pour cent à 18 mois.

«Ce qui est remarquable, parce que le dernier agent approuvé par la Food and Drug Administration pour MCL a eu un taux de réponse de 30 pour cent», explique l'auteur principal Kristie Blum, MD, professeur agrégé de médecine. «Cet essai suggère que ibrutinib pourrait améliorer considérablement le paysage des options de thérapie pour MCL."

MCL est un type de lymphome non hodgkinien, un cancer qui devrait frapper près de 70.000 Américains en 2013. Environ 7 pour cent de ces cas sera cellules B MCL, une de cancer des globules blancs appelés lymphocytes B, ou. Actuellement, les oncologues traitent MCL utilisant une chimiothérapie d'association ou de la chimiothérapie intensive, plus l'immunothérapie, suivie d'une greffe de cellules souches.

L'essai portait sur 111 patients en rechute ou réfractaire MCL qui a pris ibrutinib. L'étude a été menée sur 18 sites. Les participants avaient reçu un à cinq traitements antérieurs, qui pourraient inclure le médicament bortezomib, un agent parfois utilisé pour traiter MCL. La durée de réponse médiane estimée était de 17,5 mois, et estimé la survie sans progression médiane était de 14 mois.

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MessageSujet: Re: isf35   Mer 19 Juin 2013 - 23:27

Chronic Lymphocytic Leukemia and Ibrutinib
Results from this phase Ib/II trial showed an overall response rate (complete and partial) of 71 percent. At 26 months the estimated progression-free survival rate was 75 percent and overall survival was 83 percent.

Les résultats d'un essai de phase Ib/II ont montré un taux de réponses (complète et partielle) de 71 % À 26 mois le taux de survie sans progression était de 75% et la survie général de 83%

"Essentially all CLL patients respond well to ibrutinib, which lacks many of the side effects of chemotherapy and frequently produces long-lasting remissions even in patients with high-risk genetic lesions," says study co-leader John C. Byrd, MD, director of the division of hematology and a CLL specialist at the OSUCCC -- James.

CLL is the most common form of leukemia with an estimated 15,000 Americans diagnosed annually. It is a cancer of B cells, which are a major component of the immune system along with T cells.

Ibrutinib (PCI-32765) is the first drug designed to target Bruton's tyrosine kinase, a protein essential for CLL-cell survival and proliferation. Ibrutinib kills malignant B cells but has little effect on healthy T cells -- unlike other CLL therapies. This leaves an important arm of the immune system largely intact, enabling patients to remain healthier during treatment.

L'ibrutinib est le premier médicament pour cibler la tyrosine kinase Bruton, une protéine essentielle pour la survie de la cellule CLL et sa prolifération. L'ibrutinib tue les cellules B malignes avec peu d'effet sur les cellules saines contrairement aux autres thérapies. Cela laisse aux patients le système immunitaire qui leur permet de rester plus en santé.



The trial involved 85 relapsed CLL patients (median age, 66) who took ibrutinib once daily. Fifty-one patients received a 420 mg dose and 34 patients received an 840 mg dose. Long-term therapy was associated with modest side effects such as diarrhea, fatigue, and infection that usually resolved with no treatment delay.

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MessageSujet: isf35   Ven 7 Nov 2008 - 4:40

(Nov. 7, 2008) — Researchers at the Moores Cancer Center at the University of California, San Diego (UCSD) are conducting clinical trials of a novel therapy aimed at revving up the immune system to combat a particularly difficult-to-treat form of leukemia.

Les chercheurs font des essais pour réveiller le système immunitaire pour combattre une forme de leucémie difficlle à traiter.

The experimental therapy is being offered to patients with chronic lymphocytic leukemia (CLL) whose cancer did not respond or was resistant to initial treatment or harbors a particular chromosomal abnormality called a 17p deletion. In most of these cases, the cancer has failed to respond to further conventional therapy.

cette thérâpie expérimentale a été offerte aux patients avec la leucémie lymphocite chronique dont le cancer ne répond pas ou résiste au traitement initail ou bien a une particularité appelé effacement de 17p.  Dasn ces cas le cancer ne réponds pas bien à la thérapie conventionnelle.

In this clinical trial, patients will receive a vaccine of an immune-boosting molecule, ISF35 (Immune Stimulatory Factor 35) followed by three courses of rituximab, a monoclonal antibody, and the chemotherapy drugs fludarabine and cyclophosphamide (FCR). The trial is termed Phase I, meaning that it is aimed at testing the safety of the combination of repeat infusions of ISF35 and FCR, the latter being considered the standard and best possible CLL treatment.

Dans cette essai clinique, les patients recoivent une molécule qui booste le système immunitaire la ISF35 suivi de 3 traitements de rituximab, un anticorps monoclonal et des médicaments fludarabine et cyclophosphamide. Cet essai en est un de phase I c'est-à-dire pour tester la sécurité de la combinaison des infusions de isf35 et FCR, le traitement considéré comme le meilleur pour le CLL.

"This approach – activating immune cells followed by chemotherapy – may lead to new strategies that could be applied to other cancers," said Januario E. Castro, M.D., assistant clinical professor of medicine at the UC San Diego School of Medicine and the Moores UCSD Cancer Center, who leads the work. The vaccine therapy approach makes it possible to target the cancer cells and activate the immune system by making the cancerous leukemia B cells more visible. The activated immune system can then find and eliminate the cancer cells.


CLL can be especially hard to treat. Though chemotherapy can beat back the disease initially, and patients may do well for years, the disease invariably returns, frequently resistant to further treatment. The American Cancer Society estimates that about 15,100 new cases of CLL will occur this year in the United States, with about 4,390 deaths from the disease.

"Standard strategies for CLL involve drugs and drug combinations that result in serious toxicities, little or no improvement in survival, and poor tolerance by the elderly," Castro said. "Almost all patients eventually experience disease relapse and become less responsive to therapy. Clearly we need novel therapeutic approaches for CLL, and ISF35 therapy represents such an innovation."

According to Castro, the latest study builds on previous trials completed at UCSD and M.D. Anderson Cancer Center in Houston. "Those trials showed remarkable results for ISF35 in patients with high-risk and treatment-resistant CLL," he said, particularly when combined with chemotherapy.

Castro said that ISF35 also has the "potential to treat a range of blood cancers including lymphomas and even certain types of breast and lung cancers and melanoma," adding that future clinical trials are being planned.

Castro a dit que le ISF35 a le potentiel de traiter un grand éventail de cancer du sang incluant le lymphome et même certains types de cancer du :sein:et du


Dernière édition par Denis le Mer 19 Juin 2013 - 23:43, édité 1 fois
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