DGAP-News: MOLOGEN AG / Key word(s): Study results/Study
MOLOGEN AG: Patient enrollment completed for IMPULSE study with
immunotherapy MGN1703 in lung cancer (news with additional features)
30.10.2015 / 13:36
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PRESS RELEASE N 17 / 2015 of 10/30/2015
MOLOGEN AG: Patient enrollment completed for IMPULSE study with
immunotherapy MGN1703 in lung cancer
Berlin, 30 October, 2015 - The biotechnology company MOLOGEN AG (ISIN
DE0006637200; Frankfurt Stock Exchange Prime Standard: MGN) has achieved
the recruitment goal with the inclusion of currently 101 patients for the
IMPULSE clinical study in lung cancer. With this trial, the company aims to
explore the potential of MGN1703 in an indication with high unmet medical
need. The randomized study is designed to evaluate efficacy and safety of
MGN1703 in patients with extensive disease small cell lung cancer. With the
finalization of recruitment, the company reached another milestone in the
clinical study program of its main product, the cancer immunotherapy
MGN1703.
The multinational randomized and controlled IMPULSE trial started at the
end of March 2014 and evaluates the efficacy and safety of MGN1703 for the
treatment of extensive disease small cell lung cancer. Primary endpoint is
overall survival, the strongest possible endpoint that can be applied in
cancer studies. Pre-defined biomarkers are used in this study and may help
to identify those patients who will benefit the most from the treatment
with MGN1703. In Germany, the trial is being conducted in collaboration
with the "Aktion Bronchialkarzinom e.V." (ABC group) - a renowned German
oncologist's network of lung cancer specialists. MOLOGEN plans to start the
analysis by the end of 2016 and present results at the Annual Meeting of
the American Society of Clinical Oncology 2017 (ASCO).
"Lung cancer and especially small cell lung cancer is a cancer indication
for which the benefit of standard treatment is currently very limited. We
are pleased that we finalized patient enrolment within the timeframe
envisaged and we are very excited to learn about the effect of MGN1703 in
this disease", said Dr. Matthias Schroff, CEO of MOLOGEN AG.
The immunotherapy MGN1703 is currently investigated in three clinical
trials. Further to the IMPULSE study, MGN1703 is being tested in the
pivotal IMPALA study for first-line maintenance treatment of metastatic
colorectal cancer (mCRC); recruitment for this trial is currently open.
Furthermore, MGN1703 is also being investigated in phase I study in HIV
(TEACH). The recruitment ended in September 2015 and topline results are
expected in the first half of 2016.
For more information on the trials IMPACT, IMPALA and TEACH please visit
www.clinicaltrials.gov.
IMPULSE small cell lung cancer study
The trial titled "Randomized Clinical Study of Maintenance Therapy with
Immunomodulator MGN1703 in patients with Extensive Disease Small Cell Lung
Cancer after Platinum-Based First-Line Therapy" (IMPULSE study) has overall
survival as the primary endpoint and compares MGN1703 versus best standard
of care. To date, the study has recruited 101 patients who are suffering
from extensive disease small cell lung cancer (SCLC) and whose tumors have
responded after four cycles of standard first line therapy with
chemotherapeutics. Patients in the experimental arm receive treatment with
MGN1703 until renewed progression of the cancer disease.
Small cell lung cancer (SCLC)
Lung cancer is one of the most common cancer diseases. The two main types
are small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC).
SCLC is a fast-growing type of lung cancer that usually spreads more
quickly than NSCLC.
In the US the estimated number of new lung cancer cases per year is around
230,000 (228,000) and in Europe more than 400,000 (410,000). The estimated
number of deaths per year is around 160,000 in the US and more than 350,000
in Europe. The proportion of small cell lung cancer is approximately 15-20%
of all lung cancer cases.
When first diagnosed, approx. 60-80% of the SCLC-patients have already
distant metastases or extensive local involvement. This advanced stage is
called "extensive disease". The prognosis for extensive disease SCLC is
still very poor: median overall survival is less than 12 months and only
few patients survive for more than two years. Thus, there is a high unmet
medical need for new treatment options.
ABC Group ("Aktion Bronchialkarzinom e.V.")
The ABC Group is an association of more than 60 clinics and oncologists in
Germany. The group members have been involved in clinical studies for 13
years with the aim to optimize therapies for patients with lung cancer and
contribute to improving the lives of patients. A well-organized dialog
among the specialists ensures that studies are carried out in accordance
with most modern insights.
MGN1703
MGN1703 is an innovative DNA-based TLR9 agonist developed by MOLOGEN that
broadly activates the immune system. This activation can be utilized to
enable the immune system to increase the recognition and combat of cancer
cells. Due to this mechanism of action, it is predicted that MGN1703 can be
applied to a number of diseases.
MOLOGEN AG
With new and unique technologies and active substances, the biotech company
MOLOGEN is one of the pioneers in the field of immunotherapy. Alongside a
focus on immuno-oncology, MOLOGEN also develops immunotherapies for the
treatment of infectious diseases.
The cancer immunotherapy MGN1703 is the company's lead product and
best-in-class TLR9 agonist. Treatment with MGN1703 triggers a broad and
strong activation of the immune system. Due to this mechanism of action,
MGN1703 has the potential to be applied to various indications. MGN1703 is
currently being developed for first-line maintenance treatment of
colorectal cancer (pivotal study) and small cell lung cancer (randomized
controlled trial). Furthermore it is also being investigated in a phase I
study in HIV.
MOLOGEN's pipeline focus is on new innovative immunotherapies to treat
diseases for which there is a high medical need.
MOLOGEN AG is listed on the stock exchange and its headquarters are located
in Berlin, Germany.
www.mologen.com
Memberships in associations:
Biotechnologieverbund Berlin-Brandenburg (bbb) e.V. | BIO Deutschland e.V.
| DECHEMA - Society for chemical technology and biotechnology e.V. |
German industrial association of biotechnology (DIB) | Association for
the Promotion of Science and Humanities in Germany | Association of
German biotechnology companies (VBU) | Association of researching
manufacturers of pharmaceuticals e.V. (VFA) | Association of the chemical
industry e.V. (VCI)
MIDGE(R), dSLIM(R), EnanDIM(R) and MOLOGEN(R) are registered trademarks of
MOLOGEN AG.
Contact
Claudia Nickolaus
Head of Investor Relations & Corporate Communications
Tel: +49 - 30 - 84 17 88 - 38
Fax: +49 - 30 - 84 17 88 - 50
investor@mologen.com
Note about risk for future predictions
Certain information in this report contains forward-looking statements or
the corresponding statements with negation or versions deviating from this
or comparable terminology. These are described as forward-looking
statements. In addition, all of the information given here that refers to
planned or future results of business areas, key financial figures,
developments of the financial situation or other financial figures or
statistical data, is to be understood as such forward-looking statements.
The company points out to investors that they should not rely on these
forward-looking statements as predictions about actual future events. The
company is not obligated and refuses to accept any liability for the
forward-looking statements and has no obligation to update such statements
in order to accurately reflect the current situation.
+++++
Additional features:
Document: http://n.equitystory.com/c/fncls.ssp?u=MEFLYUFDNA
Document title: MOLOGEN AG: Patient enrollment completed for IMPULSE
study with immunotherapy MGN1703 in lung cancer
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30.10.2015 Dissemination of a Corporate News, transmitted by DGAP - a
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The issuer is solely responsible for the content of this announcement.
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Language: English
Company: MOLOGEN AG
FabeckstraÃe 30
14195 Berlin
Germany
Phone: 030 / 841788-0
Fax: 030 / 841788-50
E-mail: presse@mologen.com
Internet: www.mologen.com
ISIN: DE0006637200
WKN: 663720
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated
Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich,
Stuttgart
End of News DGAP News Service
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407319 30.10.2015
DGAP-News: MOLOGEN AG: Patient enrollment completed for IMPULSE study with immunotherapy MGN1703 in lung cancer (news with additional features)
| Source: EQS Group AG