CHICAGO and REGENSBURG, Germany, June 2 /PRNewswire/ -- 'A two-yearsurvival rate of more than 80 percent in recurrent or refractory anaplasticastrocytoma suggests a breakthrough in this devastating disease by targetedtherapy,' commented Prof. Ulrich Bogdahn, Neuro-Oncologist and CoordinatingInvestigator of the Phase IIb active-controlled dose-finding trial with AP12009 in recurrent or refractory high-grade glioma, while presenting the dataat the 44th Annual Meeting of the American Society of Clinical Oncology(ASCO) in Chicago, USA, today. The 24-month survival rate was accepted by theScientific Advice Working Party (SAWP) at the EMEA as the primary endpointfor the upcoming Phase III study in recurrent or refractory anaplasticastrocytoma patients. Furthermore, 14-month progression rate was accepted asthe endpoint for conditional approval.

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

'The effect of the drug is long-lasting and by far exceeds the period ofactive treatment,' said Prof. Bogdahn, Director of the Department ofNeuro-Oncology, University of Regensburg. This is fully supported by a steadyincrease in overall tumor response rates for 10 μM AP 12009 in recurrent orrefractory anaplastic astrocytoma, with up to 42% at 14 months. At the sametime, the initial 25%-overall response rate in the control group fell to zero.

An international, randomized, active-controlled, Phase III study toevaluate the efficacy and safety of AP 12009 as monotherapy in adult patientswith recurrent or refractory anaplastic astrocytoma will start in Q3 2008.The study drug will be compared to standard chemotherapy with eitherTemozolomide or BCNU. Antisense Pharma plans to conduct an interim analysisusing the progression rate at 14 months as the surrogate endpoint. Positiveresults will allow submission for conditional approval by the EMEA.