KLH™ protein and will provide technical and regulatory support to Araclon.
The agreement requires Stellar to deliver the first batch of Stellar KLH™ to Araclon by December 31, 2014. Araclon and Stellar have entered into a mutually exclusive contract for the supply of KLH for Araclon's beta amyloid peptide in the Alzheimer's space throughout the term of the agreement for use in Araclon's upcoming clinical trials with an active immunotherapy against Alzheimer's disease at agreed prices. Stellar and Araclon have agreed upon first negotiation rights for the exclusive supply of Stellar KLH™ in connection with the potential future commercialization by Araclon of its beta amyloid-targeting immunotherapy products. The agreement has an initial five-year term, which may be renewed by Araclon, if necessary, for additional one-year periods.
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"An agreement with Stellar Biotechnologies is very important to Araclon. A stable supply of GMP grade KLH is needed to advance in our Alzheimer's immunotherapy program through Phase II and III clinical trials," commented a source at Araclon.
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Janssen Reveals New Drug in the Pipeline for Treatment of Advanced Soft Tissue Sarcoma .
December - 10 - 2014 . Ilana Jacqueline .
The FDA recieved a New Drug Application from Janssen Research & Development LLC this month. The drug, Yondelis (trabectedin) is a new treatment for patients with advanced soft tissue sarcoma (STS)– this includes liposarcoma and leiomyosarcoma subtypes, who have received prior chemotherapy including an anthracycline.
“We are particularly proud of this filing, as it represents our commitment to YONDELIS and the people it may help,” said Peter F. Lebowitz, M.D., Ph.D., Global Oncology Head, Janssen. “The advanced soft tissue sarcoma treatment landscape has been relatively stagnant for decades and it’s our hope that YONDELIS will be a new treatment option for people living with this aggressive disease.”
Janssen also announced plans to amend the protocol for the Phase 3 randomized, open-label study ET743-SAR-3007, on which the NDA submission is based. The protocol will be revised to offer patients who were randomized to the dacarbazine comparator arm the option of receiving trabectedin treatment at their physician’s discretion. This trial is evaluating the safety and efficacy of trabectedin versus dacarbazine for the treatment of advanced liposarcoma and leiomyosarcoma, the most common types of STS in adults, in more than 500 patients previously treated with an anthracycline and ifosfamide, or an anthracycline followed by one additional line of chemotherapy. Results of the study will be presented at a future date.
“Today, we are one step closer to our goal of making another treatment option available for people living with advanced soft tissue sarcoma,” said Denise Reinke, President and CEO of Sarcoma Alliance for Research through Collaboration. “People living with this type of cancer are in urgent need of new options to help treat their disease, and we welcome new medicines that may help make a difference in their lives.”
In related news, Janssen will be revising the current U.S. trabectedin expanded access program (EAP), ET743-SAR-3002, to allow entry of eligible patients with liposarcoma and leiomyosarcoma. The program was developed to provide trabectedin to eligible patients with previously treated STS who cannot be expected to benefit from limited currently available therapeutic options. Patient enrollment will be extended to those with liposarcoma or leiomyosarcoma as soon as the protocol amendment is implemented at participating sites. Interested patients should discuss the option of accessing trabectedin through the EAP with their physician to understand if this is an appropriate option for them.
Barcelona, Europa Press 10/dic/14 . eldia.es
El Director del Programa de Epigenética y Biología del Cáncer del Instituto de Investigación Biomédica de Bellvitge (Idibell), Manel Esteller, ha establecido los patrones epigenéticos del cáncer de mama y también sus consecuencias clínicas.
El hallazgo, que se publica en la revista 'Molecular Oncology', ha permitido establecer una nueva clasificación epigenética del cáncer de mama, el más frecuente en mujeres, ha informado este miércoles el Idibell en un comunicado.
"Hemos analizado las alteraciones epigenéticas, concretamente la señal química del ADN en 500 tumores de mama, y hemos comparado los patrones obtenidos con el comportamiento clínico de estos cánceres", ha explicado explica Esteller en relación a la estrategia de la investigación.
El equipo de Esteller ha observado que existen dos subgrupos de tumores de mama, según su epigenoma: el llamado Epi-Basal, caracterizado por la pérdida de marcas epigenéticas que causa roturas en los cromosomas, y el Epi-Luminal B, que presenta una inactivación epigenética de genes importantes que deberían proteger del cáncer.
Lo más destacado del hallazgo es que el subtipo Epi-Luminal B "se comporta de forma especialmente agresiva, y está asociado a una supervivencia menor de las pacientes", ha concretado Esteller, que ha destacado la utilidad de este descubrimiento para recomendar que en estos tumores se administre quimioterapia complementaria.
"En aquellos tumores con patrón epigenético más benigno, la cirugía podría por sí sola ser curativa; evitando así los efectos secundarios de la quimioterapia", ha precisado.
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EFE // FUTURO.-
El Científico Manel Esteller ha lamentado la fuga de cerebros y que cada vez vengan menos jóvenes extranjeros a España, y ha recalcado que ”no se tiene que concebir la investigación como un lujo, sino como una necesidad”.
En la rueda de prensa celebrada para anunciar los premios del Consejo Social y de la Fundación Bosch i Gimpera de la Universidad de Barcelona (UB), el director del programa de Epigenética y Biología del Cáncer del Instituto de Investigaciones Biomédicas de Bellvitge (IDIBELL), Manel Esteller, ha aplaudido que alumnos de éxito de la UB puedan seguir investigando.
El investigador ha subrayado que “cada vez hay menos margen para crecer y tomar decisiones adecuadas para hacer investigaciones de calidad”.
“No debemos congelar la investigación, debemos crecer aunque sea poco”, ha comentado Esteller, y ha añadido que “es importante que no perdamos ningún talento por motivos económicos”.
El científico ha asegurado que “no se tiene que concebir la investigación como un lujo, sino como una necesidad”.