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Clinical Proof of Concept for TGF-beta 2-Inhibitor AP 12009 in Phase Iib EMEA provides Guidance on Phase III Design and Approval Requirements
Date:6/2/2008

xample newly diagnosed, is scheduled to start in 2009," explains Dr. Karl-Hermann Schlingensiepen, Chief Executive Officer of Antisense Pharma.

Literature

(1) Bogdahn, U. et al. "Results of a Phase IIb Active-controlled Study with AP 12009 for Patients with Recurrent or Refractory Anaplastic Astrocytoma", ASCO Annual Meeting, 2008, Abstract ID 2076

(2) Bogdahn, U. et al. "Targeted Therapy with AP 12009 in Recurrent or Refractory Glioblastoma Patients: Results of a Phase IIb Study", ASCO Annual Meeting, 2008, Abstract ID 2018

The Phase IIb study AP 12009-G004

The Phase IIb study AP 12009-G004 is an open-label, randomized, active-controlled, parallel-group dose-finding study to evaluate the efficacy and safety of two doses of AP 12009 in adult patients with recurrent or refractory high-grade glioma. Efficacy endpoints were tumor response assessed by central blinded MRI reading and survival. At 29 international clinical centers, 134 evaluable patients (39 with anaplastic astrocytoma, AA, WHO grade III and 95 with glioblastoma, GBM, WHO grade IV) have been randomized to three arms: AP 12009 10 mM, AP 12009 80 mM and standard chemotherapy (Temozolomide or PCV) as an active control. AP 12009 was administered intratumorally via one catheter as continuous high-flow microperfusion over a 7-day period every other week for up to 6 months on an outpatient treatment basis. Tumor response was assessed according to Macdonald criteria. Post-study follow-up for survival, long-term tumor response, and safety is still ongoing. Analysis of the core phase is completed.

High-Grade Glioma

Anaplastic astrocytoma and glioblastoma are the two most common forms of primary brain tumors, a diagnosis with high unmet medical need. Adults as well as children may be affected, although the age peak is at 45-65 years. Current therapies comprise surgery, radiation and/or chemotherapy. Despite recent advances, the prognosis for these patients is still po
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SOURCE Antisense Pharma GmbH
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