Antisense Pharma’s Trabedersen in Malignant Brain Tumors: Phase IIb Data Published in Neuro-Oncology
Want to listen to this article for FREE?
Complete the form below to unlock access to ALL audio articles.
Read time: 1 minute
The biopharmaceutical company Antisense Pharma announced that their international, randomized and active-controlled Phase IIb study G004-AP 12009 is published in the official journal of the American Society for Neuro-Oncology (SNO).
The article is already available online on the homepage of the journal. The investigated drug trabedersen (AP 12009) is a gene silencing antisense compound – a phosphorothioate oligodeoxynucleotide – designed to selectively downregulate the production of transforming growth factor-beta 2 (TGF-ß2) at the translational level. The trial revealed encouraging efficacy results.
Based on these data, a pivotal Phase III study in recurrent or refractory AA patients (SAPPHIRE) has already started. "We are very pleased that our Phase IIb results have been published in such an important journal as Neuro-Oncology" said Dr Hubert Heinrichs, Chief Medical Officer at Antisense Pharma. “This scientific publication substantiates the remarkable clinical benefit of trabedersen to fight high-grade glioma."
TGF-ß2 silencing – a promising approach in tumor therapy
The current situation for the treatment of malignant brain tumors is still insufficient: Despite surgical tumor resection, radio- and chemotherapy, the tumor recurs in almost all cases and the patients die within a few months. "Trabedersen fulfills a great demand for medical innovation and could contribute a considerable advance in the treatment of malignant brain tumors“ said Ulrich Bogdahn, MD, Director of the Department of Neurology, University of Regensburg and international head of the Phase IIb study.
Particularly the reversal of TGF-ß2-mediated immunosuppression plays an important role to achieve long-term response effects: "Overexpression of TGF-ß2 sustainably inhibits the activity of practically all types of immune cells, thereby forming an immunosuppressive environment around the tumor." explained Dr Karl-Hermann Schlingensiepen, Chief Executive Officer at Antisense Pharma.
"Furthermore, invasion and metastasis, proliferation and angiogenesis are simultaneously promoted by TGF-ß2 in a variety of malignant tumors, especially brain tumors. Therefore, trabedersen is a targeted multimodal therapy."
The recently published data demonstrate that TGF-ß2 suppression by trabedersen is a promising treatment against high-grade gliomas. Based on these results, a pivotal international Phase III study in recurrent or refractory AA patients has started (SAPPHIRE).
The SAPPHIRE study is currently conducted in about 50 study centers worldwide, 132 patients with recurrent or refractory anaplastic astrocytoma will be included. In July 2010 the FDA has issued an IND-authorisation for clinical studies with trabedersen for patients with highgrade-glioma. Therefore the SAPPHIRE study will also be conducted in US-American clinics soon.
The article is already available online on the homepage of the journal. The investigated drug trabedersen (AP 12009) is a gene silencing antisense compound – a phosphorothioate oligodeoxynucleotide – designed to selectively downregulate the production of transforming growth factor-beta 2 (TGF-ß2) at the translational level. The trial revealed encouraging efficacy results.
Based on these data, a pivotal Phase III study in recurrent or refractory AA patients (SAPPHIRE) has already started. "We are very pleased that our Phase IIb results have been published in such an important journal as Neuro-Oncology" said Dr Hubert Heinrichs, Chief Medical Officer at Antisense Pharma. “This scientific publication substantiates the remarkable clinical benefit of trabedersen to fight high-grade glioma."
TGF-ß2 silencing – a promising approach in tumor therapy
The current situation for the treatment of malignant brain tumors is still insufficient: Despite surgical tumor resection, radio- and chemotherapy, the tumor recurs in almost all cases and the patients die within a few months. "Trabedersen fulfills a great demand for medical innovation and could contribute a considerable advance in the treatment of malignant brain tumors“ said Ulrich Bogdahn, MD, Director of the Department of Neurology, University of Regensburg and international head of the Phase IIb study.
Particularly the reversal of TGF-ß2-mediated immunosuppression plays an important role to achieve long-term response effects: "Overexpression of TGF-ß2 sustainably inhibits the activity of practically all types of immune cells, thereby forming an immunosuppressive environment around the tumor." explained Dr Karl-Hermann Schlingensiepen, Chief Executive Officer at Antisense Pharma.
"Furthermore, invasion and metastasis, proliferation and angiogenesis are simultaneously promoted by TGF-ß2 in a variety of malignant tumors, especially brain tumors. Therefore, trabedersen is a targeted multimodal therapy."
The recently published data demonstrate that TGF-ß2 suppression by trabedersen is a promising treatment against high-grade gliomas. Based on these results, a pivotal international Phase III study in recurrent or refractory AA patients has started (SAPPHIRE).
The SAPPHIRE study is currently conducted in about 50 study centers worldwide, 132 patients with recurrent or refractory anaplastic astrocytoma will be included. In July 2010 the FDA has issued an IND-authorisation for clinical studies with trabedersen for patients with highgrade-glioma. Therefore the SAPPHIRE study will also be conducted in US-American clinics soon.
