DGAP-News: Apogenix Announces that APG101 Meets Primary Endpoint in a Controlled Phase II Trial with Glioblastoma Patients
(firmenpresse) - DGAP-News: Apogenix GmbH / Key word(s): Miscellaneous
Apogenix Announces that APG101 Meets Primary Endpoint in a Controlled
Phase II Trial with Glioblastoma Patients
08.03.2012 / 10:00
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Apogenix Announces that APG101 Meets Primary Endpoint in a Controlled Phase
II Trial with Glioblastoma Patients
- Study objective of increasing percentage of patients reaching PFS6 by
100% was substantially exceeded
- No drug-related adverse effects observed
Heidelberg, Germany, March 8, 2012 - The biopharmaceutical company Apogenix
GmbH announced today that the phase II clinical efficacy trial with APG101
has met its primary endpoint in the 2nd line treatment of 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). In the controlled, randomized,
open-label trial, patients were treated with APG101 and radiotherapy or
with radiotherapy alone.
The phase II clinical trial recruited 83 patients in 27 centers 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. Currently, there are no approved treatment options
for second line GBM patients with proven efficacy data from an actively
controlled study.
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 in the US
and Europe later this year. During treatment with APG101 for up to two
years, no drug-related adverse effects were observed.
GBM is the most frequent and aggressive brain tumor. The tumors are
characterized by a high resistance to radio- and chemotherapy and the
disease often has a devastating impact on the quality of life and life
expectancy of patients. Approximately 28,000 new cases of malignant
glioblastomas are diagnosed in the US and EU each year.
'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',
said Dr Harald Fricke, Chief Medical Officer of Apogenix. 'Through the
support of our investors, we plan to investigate the effect of APG101 in
other cancer types.'
The principle investigator of the study, Prof Wolfgang Wick of the Clinical
Cooperation Unit Neuro-Oncology, German Cancer Research Center and
Department of Neuro-Oncology, University Hospital of Heidelberg, added:
'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 tosignificantly improve the standard therapy by adding APG101.'
About Apogenix
Apogenix, a spin-out from the German Cancer Research Center (DKFZ), is
developing novel protein therapeutics for the treatment of cancer and
inflammatory diseases based either on the targeted modulation of apoptosis
(programmed cell death) or on blocking the growth of tumor cells. The
company's lead product candidate APG101 is being developed for the
treatment of Glioblastoma Multiforme (GBM), the most common and aggressive
type of primary brain tumor. In 2013, it is planned to initiate a phase II
trial with APG101 for the treatment of Myelodysplastic Syndromes (MDS).
Since its inception in 2005, the company has raised more than EUR 50
million with dievini Hopp BioTech Holding GmbH&Co. KG as main investor,
and has been awarded public grants totaling over EUR 8 million. Apogenix is
based in Heidelberg, Germany.
About APG101
The company's lead product candidate, APG101, a first-in-class, fully human
fusion protein combining the extracellular domain of the CD95 receptor and
the Fc portion of IgG, successfully completed a phase I study in 2009. In
December 2009, Apogenix started a controlled phase II trial with APG101 for
the treatment of Glioblastoma Multiforme. The patient recruitment for this
study was completed in September 2011. The primary endpoint of the trial
was successfully reached in March 2012. Apogenix was granted orphan drug
designation for APG101 in 2009 for the treatment of GBM in Europe and in
the US.
Contact
Dr Thomas Höger
CEO/CFO
Apogenix GmbH
Phone: +49 (6221) 5 86 08-0
Email: contact(at)apogenix.com
www.apogenix.com
Raimund Gabriel
MC Services AG
Email: +49 (89) 210 228 30
Email: raimund.gabriel(at)mc-services.eu
End of Corporate News
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