Apogenix GmbH, a biopharmaceutical company, has announced that APG101, designed for the 2nd line treatment of glioblastoma multiforme (GBM), has met its primary endpoint 6 months after the follow-up of the last treated patient. The trial’s primary endpoint was determined, as six months progression-free survival (PFS6), with secondary endpoints being overall survival (OS) and tolerance to APG101, including measures of patients’ quality of life (QoL).

There are no approved treatment options available at present for second line GBM patients, with evidential efficacy data from an actively controlled study.

Each year about 28,000 new cases of malignant glioblastomas are diagnosed In the U.S. and EU. GBM, the most frequent and aggressive type of brain tumor, is usually highly resistant to radio- and chemotherapy and often has a devastating impact on the patient’s quality of life and life expectancy.

Dr Harald Fricke, Chief Medical Officer of Apogenix states:

“Current treatment options for GBM are very limited, and the treatment of relapses is predominantly based on experimental approaches. In view of the results of our controlled efficacy study, we are optimistic that APG101 will be of significant patient benefit in this difficult-to-treat disease. Through the support of our investors, we plan to investigate the effect of APG101 in other cancer types.”

Researchers enrolled 83 patients with GBM who had first or second relapses and no longer responded to Temozolomide therapy from 27 German, Austrian and Russian centers in the controlled, randomized, open-label phase II clinical trial. The patients remained in the study until the tumors progressed, and were either treated with APB101 and radiotherapy, or with radiotherapy alone. The researchers observed no drug-related adverse effects after treating patients with APG101 for a period of up to two years.

The trial’s primary goal of increasing the percentage of patients’ reaching PFS6 by 100% was significantly exceeded. The company will present the trial’s data on secondary endpoints later this year at major cancer conferences in the US and in Europe.

Leading researcher, Professor Wolfgang Wick of the Clinical Cooperation Unit Neuro-Oncology, German Cancer Research Center and Department of Neuro-Oncology, University Hospital of Heidelberg, concluded:

“The promising data of a combination therapy of APG101 with radiotherapy in relapsed GBM patients leads to the suggestion that a next development step could be the combination therapy of APG101 with standard radio-chemotherapy in newly diagnosed Glioblastoma patients. The main goal should be to significantly improve the standard therapy by adding APG101.”

Written by Petra Rattue