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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

CHICAGO and REGENSBURG, Germany, June 2 /PRNewswire/ -- "A two-year survival rate of more than 80 percent in recurrent or refractory anaplastic astrocytoma suggests a breakthrough in this devastating disease by targeted therapy," commented Prof. Ulrich Bogdahn, Neuro-Oncologist and Coordinating Investigator of the Phase IIb active-controlled dose-finding trial with AP 12009 in recurrent or refractory high-grade glioma, while presenting the data at the 44th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, USA, today. The 24-month survival rate was accepted by the Scientific Advice Working Party (SAWP) at the EMEA as the primary endpoint for the upcoming Phase III study in recurrent or refractory anaplastic astrocytoma patients. Furthermore, 14-month progression rate was accepted as the endpoint for conditional approval.

The drug designed for the targeted treatment of recurrent or refractory high-grade glioma was administered as monotherapy and compared to standard chemotherapy in an international, randomized, active-controlled Phase IIb clinical trial. Efficacy results show that the 10 μM dose of AP 12009, identified in the Phase IIb trial, is superior to standard chemotherapy in anaplastic astrocytoma: Current median survival times in the 10 μM AP 12009 group are 37.2 months compared to 21.7 months in the standard chemotherapy control arm. This translates to a survival benefit of 15.5 months for patients receiving the antisense treatment over chemotherapy. In recurrent or refractory anaplastic astrocytoma, 83.3% of the patients treated with 10 μM AP 12009 survived two years or more, whereas 41.7% survived in the control arm with standard chemotherapy (1).

"The effect of the drug is long-lasting and by far exceeds the period of active treatment," said Prof. Bogdahn, Director of the Department of Neuro-Oncology, University of Regensburg. This is fully supported by a steady increase in overall tumor response rates f
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SOURCE Antisense Pharma GmbH
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