APG101 (Apogenix) meets primary endpoint in Phase II trial for Glioblastoma Multiforme - 10-Mar-2012

The Phase II clinical efficacy trial with APG101, from Apogenix, has met its primary endpoint in the 2nd line treatment of a common form of Brain Cancer, Glioblastoma Multiforme (GBM), following a six month follow up of the last patient treated. The primary endpoint of the trial was the six-month-rate of progression-free survival (PFS6) and secondary endpoints include overall survival (OS), safety and tolerability of APG101, plus parameters assessing the patients’ quality of life (QoL). Patients were treated with APG101 and radiotherapy or with radiotherapy alone. The trial recruited 83 patients in 27 centres throughout Germany, Austria, and Russia. Patients were eligible for inclusion if they had suffered from first or second relapses and if they no longer responded to treatment with Temozolomide. GBM patients participated in this study until tumor progression. The primary objective of the trial was to increase the percentage of patients reaching PFS6 by 100%. This objective was exceeded substantially. Data on secondary endpoints including OS and QoL are expected within the next few months and will be presented at major cancer conferences. Currently, there are no approved treatment options for second line GBM patients with proven efficacy data from an actively controlled study.