Abstract
1514 Background: High-grade gliomas are highly aggressive tumors showing marked transforming growth-factor-beta2 (TGF-β2) overexpression inducing proliferation, metastasis, angiogenesis and in particular immunosuppression. Methods: In 3 phase I/II dose escalation studies adult high-grade glioma patients (WHO III/IV) with recurrent tumor and evidence of tumor progression on MRI were treated with AP 12009, a TGF-β2 specific phosphorothioate antisense oligonucleotide. AP 12009 was administered intratumorally by convection enhanced delivery (CED) in 3 studies in up to 12 cycles. In the 3rd study, an indwelling pump system was used that allowed repeated treatment cycles with a single catheter placement on an out-patient basis. Safety and tolerability were primary endpoints. Secondary endpoint was clinical efficacy. Results: In only 5 of the total 24 patients “possibly” related adverse events were observed, mostly of grade 1 or 2, one was classified as serious. There were no relevant changes in laboratory value...
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