Apogenix Successfully Completes Patient Recruitment for Glioblastoma Phase II Trial with APG101
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Apogenix Successfully Completes Patient Recruitment for Glioblastoma Phase II
Trial with APG101
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* Recruitment of 83 patients completed
* Final study results expected in the first quarter of 2012
Heidelberg, September 20, 2011 - The biopharmaceutical company Apogenix GmbH
today announced the completion of patient recruitment for the ongoing clinical
phase II trial with APG101 for the treatment of glioblastoma, which started in
December 2009. As a result of an interim analysis for efficacy and safety
evaluation in June 2011, the Data Safety Monitoring Board recommended to
continue the study until completion as planned. Final results of the phase II
trial are expected in the first quarter of 2012.
In the open-label, randomized, controlled study a total of 83 patients with
first or second relapse/progression of Glioblastoma Multiforme (GBM, brain
tumor) were included in 25 centers in Germany, Austria, and Russia. Patients
were either treated with APG101 plus reirradiation or reirradiation only.
Primary endpoint of the study is the 6-month-rate of progression free survival
(PSF6). Secondary endpoints include overall survival, safety and tolerability of
APG101, and parameters measuring the patients' quality of life.
APG101 is a fully human protein and provides an innovative therapeutic approach
for the treatment of GBM. APG101 is the first inhibitor of the CD95 ligand
(CD95L) which is currently in clinical development and which has been granted
orphan drug designation in Europe and the US in 2009.
GBM is the most frequent and aggressive glioma (tumor deriving from glia cells).
The tumor cells are characterized by a high resistance to radio- and
chemotherapy and the disease often has a devastating impact on patients.
Approximately 28,000 new cases of malignant glioblastomas are diagnosed in the
US and EU each year.
Dr. Harald Fricke, CMO of Apogenix, commented: "The completion of the patient
recruitment is an important milestone for Apogenix and our first clinical
development program. The evaluation of the study is being conducted with great
effort by everyone involved and the results are eagerly anticipated. First
results of the preliminary evaluation in June 2011 are encouraging."
The study's lead clinician, Prof. Wolfgang Wick (Clinical Cooperation Unit
Neurooncology, German Cancer Research Center, and Department of Neurooncology,
University Hospital of Heidelberg), added: "This is one of only a few controlled
phase II trials in glioblastoma and scientists, physicians as well as
glioblastoma patients are impatiently awaiting the results. Besides
investigating APG101's innovative mechanism of action, the efficacy of
reirradiation is also studied in a multicenter controlled trial for the first
time."
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 invasive 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. Since its inception in autumn 2005, the company has raised ?43
million and has been awarded public grants totaling of more than ?6 million.
Apogenix is based in Heidelberg, Germany.
About APG101
The company's lead product candidate, APG101, a fully human, soluble 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 has been
recently completed. Apogenix has been granted orphan drug designation for APG101
in 2009 for the treatment of GBM in Europe and the US.
Contact
Dr. Thomas Höger Raimund Gabriel
CEO MC Services AG
Apogenix GmbH Phone: +49 (89) 210 228 30
Phone: +49 (6221) 5 86 08-0 Email: raimund.gabriel(at)mc-services.eu
Email: contact(at)apogenix.com
www.apogenix.com
--- End of Message ---
Apogenix
Apogenix GmbH Heidelberg Germany
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[HUG#1547718]
Unternehmensinformation / Kurzprofil:
Datum: 20.09.2011 - 09:30 Uhr
Sprache: Deutsch
News-ID 67437
Anzahl Zeichen: 5652
contact information:
Town:
Heidelberg
Kategorie:
Business News
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