DGAP-News: Apogenix to Present Positive Phase II Results of APG101 in Glioblastoma Multiforme at ASCO
(firmenpresse) - DGAP-News: Apogenix GmbH / Key word(s): Miscellaneous
Apogenix to Present Positive Phase II Results of APG101 in
Glioblastoma Multiforme at ASCO
29.05.2012 / 10:15
---------------------------------------------------------------------
Press Release
Apogenix to Present Positive Phase II Results of APG101 in Glioblastoma
Multiforme at ASCO
- Primary study endpoint of increasing percentage of patients reaching
PFS6 by 100% was exceeded by a factor of five
Heidelberg, Germany, May 29, 2012 - The biopharmaceutical company Apogenix
GmbH announced today that results of the recently completed phase II
clinical efficacy trial with APG101 for the treatment of Glioblastoma
Multiforme (GBM) will be presented at the world's largest oncology congress
ASCO - the Annual Meeting of the American Society of Clinical Oncology - in
Chicago on June 1, 2012. An oral presentation of the data will be held on
Friday, June 1 2012, at 4.30 pm local time (CDT).
In this comparative, randomized, open-label trial, patients were treated
with either a combination of APG101 and radiotherapy or with radiotherapy
alone. The primary endpoint was progression-free survival at six months
(PFS6). In the APG101 study arm, the proportion of GBM patients who
survived progression free for more than six months, improved by five times
compared to the comparison group.
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.
GBM is the most frequent and aggressive brain tumor type. The tumors are
characterized by a high resistance to radiotherapy and chemotherapy. 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.
Information regarding the poster presentation:
Abstract-Nr.: 2034
Abstract Title: APG101_CD_002: A phase II, randomized, open-label,
multicenter study of weekly APG101 plus reirradiation versus reirradiation
in the treatment of patients with recurrent glioblastoma.
Time and place of presentation: Friday, June 1st 2012, 1.00 - 5.00 pm
Chicago local time (CDT), oral presentation at 4.30 pm local time (CDT)
Poster-Session: General Poster Session: Central Nervous System Tumors
Authors: M. Bendszus, J. Debus, W. Wick, G. Kobyakov, T. Martens, O. Heese,
J. Pichler, R. Stupp, C. Kunz, H. Fricke;
The Abstract is available at the ASCO website under the following link:
http://abstract.asco.org/AbstView_114_97870.html.
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 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 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.
ContactEnd of Corporate News
Dr Thomas Höger Raimund Gabriel
CEO/CFO 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
---------------------------------------------------------------------
29.05.2012 Dissemination of a Corporate News, transmitted by DGAP - a
company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.
DGAP's Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de
---------------------------------------------------------------------
171777 29.05.2012
Themen in dieser Pressemitteilung:
Unternehmensinformation / Kurzprofil:
Datum: 29.05.2012 - 10:15 Uhr
Sprache: Deutsch
News-ID 150529
Anzahl Zeichen: 4181
contact information:
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 349 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"DGAP-News: Apogenix to Present Positive Phase II Results of APG101 in Glioblastoma Multiforme at ASCO"
steht unter der journalistisch-redaktionellen Verantwortung von
Apogenix GmbH (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
