DGAP-News: Apogenix GmbH: Apogenix: APG101 Exceeds Expectations with Controlled Phase II Clinical Trial in Treatment of Recurrent Glioblastoma
(firmenpresse) - DGAP-News: Apogenix GmbH / Key word(s): Study
Apogenix GmbH: Apogenix: APG101 Exceeds Expectations with Controlled
Phase II Clinical Trial in Treatment of Recurrent Glioblastoma
26.07.2012 / 07:30
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Apogenix: APG101 Exceeds Expectations with Controlled Phase II Clinical
Trial in Treatment of Recurrent Glioblastoma
- Primary endpoint of PFS6 shows significant improvement
- PFS median P-value: 0.0114
- Positive results confirmed by secondary endpoints
Heidelberg, Germany, July 26, 2012 - 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.
APG101 Study Results
APG101+RT RT alone P Value Hazard RatioNotes: PFS6: Progression Free Survival for six months; * Chi2-Test; **
PFS6 (primary endpoint) 20.7% 3.8% 0.0485* N.A.
PFS (median) 19.7 weeks 10.8 weeks 0.0114** 0.46
Cox-Regression
Prof Wolfgang Wick of the Clinical Cooperation Unit Neuro-Oncology, German
Cancer Research Center and Department of Neuro-Oncology, University
Hospital of Heidelberg, the Principle Investigator, said: 'The present
study is an unexpectedly huge step forward in the development of new and
innovative therapeutic concepts for patients with glioblastoma. The
magnitude of the therapeutic effect of APG101 compensated the relatively
small size of the study. More than 20% of relapsed patients being free of
progression after 6 months in a controlled trial was last observed some 10
years ago when temozolomide was introduced into the care of glioblastoma
patients.'
'The immediate patient benefit of APG101 is substantiated by the positive
effect of the compound on the quality of life. This study represents a new
development in the treatment of brain tumors that not only promises a
clinical benefit but proves it in a randomized controlled clinical study
and thus fuels the hope for better patient care,' Prof Wick added.
'The trial was designed as a randomized controlled phase II proof of
concept study in GBM, which is an exception in phase II development, but in
this way it was clearly demonstrated to our investors and potential
licensing partners that APG101 is efficacious and offers a new treatment
option for glioblastoma patients,' said Dr Harald Fricke, Chief Medical
Officer of Apogenix GmbH. 'We will now accelerate discussions with a number
of pharma and biotech companies to decide on the next development steps
plus potential new indications in order to make this innovative drug
available to patients as soon and as widely as possible.'
The phase II, open label, randomized clinical trial recruited 84 patients
in 25 centers throughout Germany, Austria, and Russia. Glioblastoma
patients were eligible for inclusion if they had suffered from a first or
second relapse and if they no longer responded to treatment with
temozolomide. Patients participated in this study until tumour progression.
Apogenix is currently planning a phase II proof of concept trial with
APG101 in Myelodysplastic syndromes (MDS). The trial is expected to begin
in the first half 2013.
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 tumour cells. The
company's lead product candidate APG101 is being developed for the
treatment of glioblastoma, the most common and aggressive type of primary
brain tumour. Since its inception in 2005, the company has raised more than
EUR50 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. 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 glioblastoma in Europe
and in the US.
About Glioblastoma
Glioblastoma is the most frequent and aggressive brain tumour belonging to
the group of gliomas. The tumour cells show a high resistance to radiation
and chemotherapy. They spread and infiltrate the neighbouring tissue so
quickly that eradicative surgery is often impossible. Due to the diffuse
infiltration into brain tissue, recurrence is often experienced within
months of the initial treatment. Approximately 28,000 new cases of
malignant glioma are diagnosed in the US and EU each year (Source: US
National Cancer Registry). The current standard therapy focuses on surgery,
followed by radiotherapy and chemotherapy. The relative survival rate for
adults diagnosed with glioblastoma is less than 30% within one year of
diagnosis, only 3% of patients live longer than five years after primary
diagnosis (Source: Central Brain Tumor Registry of the United States)
showing the high unmet medical need in this indication. Currently, there
are no approved treatment options for second line glioblastoma patients
with proven efficacy data from an actively controlled study.
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
Phone: +49 (89) 210 228 30
Email: raimund.gabriel(at)mc-services.eu
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