Apogenix' APG101 Demonstrates Significant Prolongation of Overall Survival in Biomarker-Positive Patients in Phase II Trial for the Treatment of Recurrent Glioblastoma
Apogenix' APG101 Demonstrates Significant Prolongation of Overall Survival in
Biomarker-Positive Patients in Phase II Trial for the Treatment of Recurrent
. Processed and transmitted by NASDAQ OMX Corporate Solutions.
The issuer is solely responsible for the content of this announcement.
Topline Data Will Be Presented at Biotech Showcase
* Identification of a predictive epigenetic biomarker
* Significant increase in median overall survival in biomarker-positive
* Excellent safety profile and very good tolerability of APG101
Heidelberg, Germany, Jan. 13, 2014 - Apogenix, a clinical stage
biopharmaceutical company, announced today the successful completion of its
phase II proof-of-concept trial with APG101 in patients with recurrent
glioblastoma. All endpoints of the randomized controlled trial that compared the
efficacy and safety of a combination therapy of APG101 and radiotherapy versus
radiotherapy alone were achieved or exceeded. During treatment with APG101 for
up to two years, no drug-related serious adverse events were observed,
underlining the excellent safety profile and very good tolerability of APG101.
The study's primary endpoint - progression-free survival at six months (PFS6) -
was met with a statistically significant fivefold improvement in the rate of
patients reaching PFS6, as previously reported. The results demonstrate that
patients having a newly-identified epigenetic biomarker associated with the CD95
ligand - the target of APG101 - experienced the greatest benefit from treatment
with APG101. The trial showed a statistically significant (p=0.003) prolongation
of overall survival in biomarker-positive patients treated with APG101, with a
median overall survival of 16.1 months compared to 6.5 months in patients
treated with radiotherapy alone. This biomarker will be validated in future
clinical trials and in additional indications.
"The results of the trial have exceeded our expectations," said Harald Fricke,
M.D., Chief Medical Officer of Apogenix. "Besides TemodarÂ® and GliadelÂ®, APG101
is the first drug candidate in nearly 20 years that has demonstrated a
substantial increase in overall survival in a randomized controlled phase II
trial. All clinical endpoints show a clear advantage of the treatment group over
the control group and thus demonstrate the clinical efficacy of APG101 in the
treatment of recurrent glioblastoma."
"We are currently developing a companion diagnostic to identify patients who
will most likely respond best to treatment with APG101, so glioblastoma patients
can benefit from a personalized treatment approach. Apogenix is in close
consultation with the regulatory authorities EMA and FDA to agree on a
development strategy toward rapid approval of APG101 for the treatment of
glioblastoma," Harald Fricke added.
The complete data set will be published in a high-impact medical journal. Thomas
Hoeger, Ph.D., Chief Executive Officer of Apogenix, will present a summary of
the results at the Biotech Showcase(TM) in San Francisco. The presentation will
take place on Tuesday, Jan. 14, at 4 p.m. PST at the Parc 55 Wyndham San
Francisco - Union Square.
About the Phase II Trial in Recurrent Glioblastoma
A total of 84 patients at 25 clinical sites in Germany, Austria, and Russia
participated in this randomized controlled phase II efficacy trial in recurrent
glioblastoma. Patients were eligible for inclusion if they suffered from first
or second relapse of glioblastoma and were refractory to standard therapy.
Patients randomized into the APG101 arm were treated until further disease
progression. At this time, there are still seven surviving patients in the
treatment group and one patient in the control group who are being monitored in
order to collect overall survival data.
Apogenix develops protein therapeutics that could transform the treatment of
life-threatening diseases by targeting critical pathways involved in the growth,
migration, and apoptosis of diseased cells. The company's lead drug candidate
APG101 is currently being evaluated in patients with glioblastoma - a disease
with a tremendous need for new and effective therapies. A randomized controlled
phase II trial in recurrent glioblastoma has shown that APG101 prolongs overall
survival and improves quality of life, while exhibiting an excellent safety
profile. Apogenix is also developing a companion diagnostic to identify patients
who may respond best to treatment with APG101.
Since its inception in fall 2005, Apogenix has raised more than 50 million euros
from its investors and was awarded public grants totaling 8.5 million euros. The
company is based in Heidelberg, Germany.
Apogenix' lead drug candidate APG101 is a fully human fusion protein that
consists of the extracellular domain of the CD95 receptor and the Fc portion of
an IgG antibody. The interaction between the CD95 ligand and the CD95 receptor
activates an intracellular signaling pathway that stimulates the invasive growth
and migration of tumor cells, such as glioblastoma cells. APG101 binds to the
CD95 ligand and thus inhibits activation of the CD95 signaling pathway,
resulting in reduced tumor cell growth and migration. APG101's unique mode of
action supports its significant potential for the treatment of other life-
threatening diseases, such as myelodysplastic syndromes as well as solid tumors
beyond glioblastoma. APG101 was granted orphan drug status for the treatment of
glioma in the EU and for the treatment of glioblastoma and myelodysplastic
syndromes in the US.
Thomas Hoeger, Ph.D., CEO/CFO
Phone: +49 (6221) 58 60 80
Martina Schwarzkopf, Ph.D. Raimund Gabriel
Russo Partners, LLC MC Services AG
Phone: +1 (212) 845 4292 Phone: +49 (89) 210 228 30
Press release (PDF):
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Apogenix via GlobeNewswire