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Antisense Pharma: Promising Phase IIb Results of Targeted Therapy,with AP 12009 in Recurrent Anaplastic Astrocytoma

CHICAGO and REGENSBURG - June 21, 2007 - “In anaplastic astrocytoma, AP 12009 as a monotherapy is actually clearly superior to temozolomide,” Prof. Albert Wong, M.D., Stanford University, California, U.S.A. commented on the international Phase IIb study with the TGF-beta 2-inhibitor AP 12009, under development by Antisense Pharma. Prof. Wong discussed the results of the study in the poster discussion session on central nervous system tumors at the 43rd Annual Meeting of the American Society of Clincal Oncology (ASCO) in Chicago, USA, this month.

The Phase IIb study AP 12009-G004 is an open-label, randomized, actively-controlled, parallel-group dose-finding study to evaluate the efficacy and safety of two doses of AP 12009 in adult patients with recurrent 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 ?M, AP 12009 80 ?M and chemotherapy (Temozolomide or PCV) as a 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 (1, 2). Post-study follow-up for survival, long-term tumor response, and safety is still ongoing. Analysis of the core phase for AA patients is completed.

Tumor response was assessed according to Macdonald criteria. The response rate for AP 12009 10 ?M in anaplastic astrocytoma patients steadily increased in the course of 14 months, whereas in the chemotherapy treatment arm a transient peak of the response rate at 6 months was not sustainable and decreased to zero at 14 months. Response rates were higher in the AP 12009 10 ?M group compared to the AP 12009 80 ?M group. The
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