Apogenix: APG101 Exceeds Expectations With Controlled Phase II Clinical Trial in Treatment of Recurrent Glioblastoma
7/26/2012 10:01:36 AM
HEIDELBERG, Germany--(BUSINESS WIRE)--The biopharmaceutical company Apogenix GmbH announced today that the phase II clinical proof of concept trial with APG101 as treatment of recurrent glioblastoma has met and exceeded expectations in the final analysis of the data. In this randomized controlled clinical study the patients were treated either with a combination of APG101 plus radiotherapy (APG101+RT group) or radiotherapy alone (RT group). The primary objective of the trial was to increase the percentage of patients reaching progression free survival for six months (PFS6) by >100%. In addition, all the important secondary endpoints evaluated so far, including safety and tolerability, indicate that APG101 is a potent new treatment option for glioblastoma, with an excellent safety profile. The quality of life (QoL) as measured by a standardized questionnaire was maintained and even improved in 67% of the patients in the APG101+RT group, but worsened in 66% of patients in the RT group. In addition, in more than 50% of the APG101 treated patients medication with corticosteroids could be reduced or even stopped compared to only 28% of patients from the RT group. During treatment with APG101 for up to two years, no drug-related serious adverse events were observed.
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