DGAP-News: MOLOGEN AG: Efficacy of MGN1703 DNA cancer medicine far exceeds expectations
(firmenpresse) - MOLOGEN AG / Miscellaneous
08.06.2010 09:01
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- Data evaluation concluded for clinical phase 1b study
- Stabilization of patients with advanced cancer diseases accomplished
- Presentation of data at the annual conference of the 'American Society of
Gene and Cell Therapy'
Berlin, 08 June 2010. The Berlin based biotechnology company MOLOGEN AG
completed the evaluation of its clinical phase 1b study with the DNA
immunomodulator MGN1703. The evaluation mainly confirmed the preliminary
efficacy data of the DNA-based immunomodulator: The study showed that the
efficacy of MGN1703 clearly exceeded expectations in the treatment of
patients with advanced metastatic tumors: the cancer diseases of several
patients could be stabilized during the course of treatment.
In the phase 1b open-label clinical study, performed at clinics at the
universities of Essen and Cologne, patients were included who had various
types of far-advanced metastatic and progressive solid tumor diseases for
whom no further standard treatment options were available. As part of the
study, patients were treated with MGN1703 in steadily increasing single and
multiple dosage regimens. An accelerated dosage escalation procedure was
selected that enabled dosage levels to increase from 0.25 mg to 60 mg per
application in just five steps.
The investigational medicinal products were firstly examined as a single
treatment within each dosage phase. When tolerability was good, the
patients were then treated, following each single-dosage stage, with the
same dosage twice a week over a period of 6 weeks, i.e. 12 injections.
Following the 6-week period, and when patients responded to MGN1703 with a
demonstrable stabilization of the cancer disease (disease control), they
were then treated with MGN1703 twice a week for a further 6-week period,
i.e. a further 12 injections.
The co-ordinating investigator, Prof Dr Max Scheulen, a specialist for
internal medicine, hematology and oncology at the Clinic for Internal
Medicine (tumor research) at the University Hospital of Essen, said: 'Far
advanced metastatic
tumor diseases are especially difficult to treat when established therapies
have been applied without showing any efficacy. In that respect one could
say that any observed stabilization may be the result of the treatment with
MGN1703. Nonetheless is it necessary to further examine those observations
and to confirm them in a randomized comparison as it is not possible to
predict the natural and individual course of tumor development. At the same
time, MGN1703 is well tolerated and based on the results of the phase Ib
study it is anticipated that MGN1703 has the potential to offer cancer
patients a new treatment option.
Cancer stabilization
A total of 24 patients were included in the initial multiple-dosage part of
the study. The disease stabilized in 9 of these following the first cycle
of treatment. As part of the second 6-week multiple stage, 6 patients were
treated. In 3 of them a continued stabilization of the disease was evident.
Those patients whose advanced tumor disease could be stabilized as part of
the MGN1703 study then had the option to take part in a so-called
compassionate use program and be treated externally to the study with
MGN1703 twice a week for 6 weeks. Depending on the clinical response, this
six-week treatment program was then repeated several times.
A total of 4 patients were included in the compassionate use program. For 3
of these patients, initially advanced cancers could be stabilized over
extended periods. For example, a patient with colorectal cancer was able to
be stabilized for a period lasting 14 months and showed a significant
reduction of the metastases. In another patient with colorectal cancer, the
disease could be stabilized over a 5 month period.
The disease in a patient with advanced lung cancer (non-small cell lung
cancer) has now been stabilized for a total of 21 months. When the disease
began to progress again after 14 months, the patient was re-treated with
MGN1703 with a stabilization of the disease again being evident.
Excellent tolerability
As well as the impressive treatment outcomes for individual patients, the
completed evaluation of data on the safety and tolerability of MGN1703 also
confirmed the existing data to date. The side-effects that could be
associated with MGN1703 were merely minor and common symptoms such as
tiredness, headaches, rashes or an increased temperature. These also
occurred only in individual cases. Side-effects did not cause the study to
be terminated in any patient. None of the examined dosage levels showed any
intolerability. For repeated dosages, no accumulation of MGN1703 in
patients' bodies was observed. In the phase 2 clinical study with patients
with metastatic colorectal cancer, the highest examined dosage levels of 60
mg per application will therefore be used as planned.
MOLOGEN also presented its clinical data for the completed phase 1b study
with MGN1703 at this year's conference of the 'American Society of Gene and
Cell Therapy' (ASGCT) in Washington.
'We are excited about the outcomes of the phase 1b study. Even though
relatively few patients were treated, the results impressively demonstrate
the potential of MGN1703', said Dr. Matthias Schroff, CEO of MOLOGEN AG. 'I
am also very pleased that we were able to actually help some of these
seriously ill patients. I would like to extend my deep gratitude to all the
patients for participating in the study'.
About MGN1703
MGN1703 is based on dSLIM(R) ('Double Stem Loop Immunomodulator'), an
innovative DNA-based TLR9 agonist developed by MOLOGEN. dSLIM(R) activates
the immune system against tumor-associated antigens by targeting various
'danger' sensing receptors on certain immune cells, primarily TLR.
Tumor-associated antigens (TAA) are released by cancer cells as a result of
chemotherapy and radiation therapy. Once activated by dSLIM(R), the immune
system is able to overcome its fatal tolerance toward cancer cells as well
as towards TAA, and attacks them selectively.
The results of the completed phase 1b study demonstrate an excellent safety
profile of MGN1703. Treatment with the investigational medicinal product
was well tolerated and no dose-limiting or serious side-effects were
identified.
Very promising signs of efficacy were also found. MGN1703 was able to delay
the progression of cancer diseases by at least 6 weeks in many cases,
including patients with advanced metastatic tumor diseases with no further
standard treatment options like the ones selected for the phase 1b study.
In some cases it was even possible to delay the progression of the disease
for up to 14 months.
In March 2010, MOLOGEN has received approval from the competent German and
Austrian health authorities to conduct a continuative clinical study with
MGN1703. The study is a phase 2, randomized, placebo-controlled,
double-blind, multicenter clinical study to determine the efficacy and
safety of subcutaneously administered MGN1703 for the treatment of
metastatic colorectal cancer patients who responded to first-line therapy
(IMPACT-study). The study is expected to start soon.
About MOLOGEN
MOLOGEN AG, a biopharmaceutical company based in Berlin, specializes in the
research anddevelopment of innovative medicines based on DNA structures.
Activities focus on product developments for the treatment of cancer and
vaccines for serious infections. MOLOGEN was founded in 1998 and is among
the few biotechnology companies in the world with well-tolerated, DNA-based
cancer treatment in the clinical development stage. MOLOGEN AG shares are
listed in the Prime Standard of Deutsche Börse (ISIN DE 0006637200).
Disclaimer concerning prognoses
Certain statements in this communication contain formulations or terms
referring to the future or future developments, as well as negations of
such formulations or terms, or similar terminology. These are described as
forward-looking statements. In addition, all information in this
communication regarding planned or future results of business segments,
financial classification numbers, developments of the financial situation,
or other financial or statistical data contains such forward-looking
statements. The company cautions prospective investors not to rely on such
forward-looking statements as certain prognoses of actual future events and
developments. The company is neither responsible nor liable for these
forward-looking statements. It is not responsible for updating such
information, which only represents the state of affairs on the day of
publication.
MOLOGEN AG
Contact: Jörg Petrass
Email: investor(at)mologen.com
Telephone: +49-30-84 17 88-13
Fax: +49-30-84 17 88-50
Kirchhoff Consult AG
Dr Kay Baden
Email: baden(at)kirchhoff.de
Telephone: +49 40 60 91 86 39
08.06.2010 09:01 Ad hoc announcement, Financial News and Media Release distributed by DGAP. Medienarchiv atwww.dgap-medientreff.deandwww.dgap.de---------------------------------------------------------------------------
Language: English
Company: MOLOGEN AG
Fabeckstraße 30
14195 Berlin
Deutschland
Phone: 030 / 841788-0
Fax: 030 / 841788-50
E-mail: info(at)mologen.com
Internet: www.mologen.com
ISIN: DE0006637200
WKN: 663720
Listed: Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr
in Berlin, München, Düsseldorf, Stuttgart, Hamburg
End of News DGAP News-Service
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Datum: 08.06.2010 - 09:01 Uhr
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