Trabedersen

01/01/2008 - "After providing preclinical proof of concept, the safety and efficacy of AP 12009 were assessed in clinical phase I/II open-label dose-escalation studies in recurrent or refractory high-grade glioma patients. "
02/01/2006 - "After providing preclinical proof of concept, we assessed safety and efficacy of AP 12009 in clinical phase I/II open-label dose escalation studies in high-grade glioma patients. "
12/01/2011 - "In patients with high-grade glioma, intratumoral treatment with trabedersen is currently evaluated in a pivotal, randomized and active-controlled phase III study. "
05/01/2011 - "Convection-enhanced delivery of a transforming growth factor-beta2 inhibitor trabedersen for recurrent high-grade gliomas: efficacy real or imagined?, in reference to Bogdahn et al. (Neuro-Oncology 2011;13:132-142)."
01/01/2011 - "Superior efficacy and safety for 10 µM trabedersen over 80 µM trabedersen and chemotherapy and positive risk-benefit assessment suggest it as the optimal dose for further clinical development in high-grade glioma."

01/01/2005 - "This favorable safety profile proves the suitability of AP 12009 for local administration in brain tumor patients from the point of view of toxicology."
01/01/2005 - "In the clinical setting, AP 12009 is administered intratumorally by continuous infusion directly into the brain tumor. "
07/01/2009 - "In a phase IIb trial, improved survival was observed in patients with brain tumors who were intratumorally administered trabedersen, compared with patients receiving standard chemotherapy. "
07/01/2009 - "Trabedersen is indicated for the treatment of malignant brain tumors and other solid tumors overexpressing TGFbeta2, such as those of the skin, pancreas and colon. "

07/10/2012 - "In particular, in the field of immunotherapy, a pilot phase I study tested for first time a carcinoembryonic antigen (CEA)-based vaccine (Abstract #2561) on patients with pancreatic adenocarcinoma and another one the optimal dose and efficacy of trabedersen, an inhibitor of tissue growth factor-beta 2 (TGF-β2) aiming to enhance antitumor immune responses (Abstract #4034). "

07/01/2009 - "Meanwhile, continued research on trabedersen should help to determine the roles of TGFbeta2 in cancer and also further the development of antisense technology."
01/01/2011 - "Prespecified AA subgroup analysis showed a significant benefit regarding the 14-month tumor control rate for 10 µM trabedersen vs chemotherapy (p= .0032). "
12/01/2011 - "In three phase I/II studies and a randomized, active-controlled dose-finding phase IIb study, trabedersen treatment of high-grade glioma patients with recurrent or refractory tumor disease led to long-lasting tumor responses and so far promising survival data. "
01/01/2007 - "Clinically, the antisense compound AP 12009 was assessed in three Phase I/II-studies for the treatment of patients with recurrent or refractory malignant (high-grade) glioma WHO grade III or IV. Although the study was not primarily designed as an efficacy evaluation, prolonged survival compared to literature data and response data were observed, which are very rarely seen in this tumor indication. "
07/01/2009 - "Trabedersen is indicated for the treatment of malignant brain tumors and other solid tumors overexpressing TGFbeta2, such as those of the skin, pancreas and colon. "

06/01/2011 - "Additionally, trabedersen reversed TGF-β2-mediated immunosuppression of pancreatic cancer cells targeted by lymphokine activated killer (LAK) cells, resulting in considerably increased LAK cell-mediated cytotoxicity. "
06/01/2011 - "Here, we report on the antitumor activity of trabedersen in human pancreatic cancer cells and in an orthotopic xenograft mouse model of human metastatic pancreatic cancer. "
06/01/2011 - "Trabedersen reduced TGF-β2 secretion in human pancreatic cell lines with an IC50 in the low μM range without transfection reagent, clearly inhibited cell proliferation, and completely blocked migration of pancreatic cancer cells. "
12/01/2011 - "Intravenous application of trabedersen for the treatment of patients with advanced pancreatic carcinoma, metastasizing melanoma, or metastatic colorectal carcinoma is assessed in a currently ongoing phase I/II dose escalation study."
06/01/2011 - "Moreover, in an orthotopic mouse model of metastatic pancreatic cancer, intraperitoneal (i.p.) treatment with trabedersen significantly reduced tumor growth, lymph node metastasis and angiogenesis. "