DGAP-News MOLOGEN AG attains the goals of the renal cancer study with MGN1601 ahead of schedule
0
DGAP-News: MOLOGEN AG / Key word(s): Miscellaneous
MOLOGEN AG attains the goals of the renal cancer study with MGN1601
ahead of schedule
21.11.2011 / 08:01
- Preparation displays good tolerability and safety
- Study goals attained with fewer patients than planned
- Follow-up studies in planning
Berlin, November 21, 2011 - The biotechnology company MOLOGEN AG today
announces that the primary study goals of the phase I/II clinical study
with MGN1601, which involve examining the tolerability and safety of the
novel preparation, have been attained ahead of schedule in full measure.
Hence in coordination with the investigators, the Paul-Ehrlich-Institut and
the responsible ethics commission, it was possible to abandon the
recruitment of further patients.
Very good tolerability
Overall, the observed adverse events that could possibly arise in
connection with treatment with MGN1601 (light fever, edema, skin rash,
itching, joint pains) were merely graded as light (´grade 1´). No kind of
serious side effects or intolerability occurred that would lead to
discontinuation of treatment. Overall, the treatment with MGN1601 was
tolerated exceedingly well.
Promising efficacy data
The first results on the efficacy of MGN1601 are also extremely positive.
The study with MGN1601 involved a total of 19 patients, for whose advanced
renal cancer disease no further currently-approved therapy options were
available. Nine patients completed the full 3-month treatment cycle. In
the case of one patient, the size of the metastases was reduced by more
than 50%, and in two cases, progress of the renal cancer was stopped. Two
patients continued to receive treatment as planned within the framework of
the study´s extension phase. The therapeutic success with these two
patients has now lasted for more than 6 months. In concordance with the
investigators and against a background of all seriously ill participants in
the study, these therapeutic results are viewed as a considerable success
for the preparation MGN1601. One patient is still in the first phase of
therapy.
Due to good tolerability, and in coordination with the investigators
involved, MOLOGEN AG has requested premature cancellation of patient
recruitment. The original plan was to recruit 24 patients. The
Paul-Ehrlich-Institut and the responsible ethics commission have approved
the premature cancellation of patient recruitment. The treatment of all
three patients that are currently still taking part in the study will
continue as planned.
MOLOGEN AG will evaluate further data from the clinical study and plans a
follow-up study to now confirm the efficacy of MGN1601 in the treatment of
renal cancer in patients that are in a much earlier stage of the disease.
Dr. Matthias Schroff, CEO of MOLOGEN AG, comments: ´The good tolerability
of our renal cancer therapy MGN1601 is confirmed by the permission to
prematurely cancel patient recruitment. Our expectations of the study have
been met in full. Hence we have a promising basis for how to approach
further-reaching studies with this preparation in future.´
Therapeutic vaccination
The procedures developed by MOLOGEN AG for cell-based gene therapy against
renal cancer involve a therapeutic vaccination to combat advanced tumors of
the kidneys and the prevention of their reappearance after operations and
medical treatment.
The basis of the therapy is human renal cancer cells. MOLOGEN itself has
established a unique renal cancer cell line for this purpose. These cancer
cells which are foreign (allogenic) for the patient are ´gene-modified´
with the help of MIDGE(R) DNA vectors with additional genetic information
and combined with MOLOGEN´s own DNA immune modulator dSLIM(R) as
effectiveness enhancer (adjuvant).
The active principle of the cell-based gene therapy consists of provoking a
cross-reaction of the immune system of the patients against their own
cancer cells after the immune system has learned by the reaction against
the gene-modified, foreign cancer cells how cancer cells typically appear.
In preclinical investigations, the preparation has already exhibited
outstanding tolerability and effectiveness.
About renal cancer
Renal cancer is the most frequently occurring malignant tumor of the
kidneys with 200,000 incidences annually throughout the world. According to
the Robert Koch Institute, there are 15,000 patients affected with this
illness in Germany alone. Among these patients around 30% already have
distant metastases at the time of initial diagnosis, which significantly
reduces the success of a therapy. The tumor is known for not responding to
radiation or chemotherapy. The use of preparations which are currently
available on the market are accompanied by considerable side effects.
Therefore a great medical need still exists for new, effective medications
with low side effects for the treatment of renal cancer. With MGN1601, this
approach is precisely followed.
Orphan Drug Status
The cell-based gene therapy against renal cancer has received the Orphan
Drug Status from the European Medical Agency (EMA). This allows MOLOGEN AG
to have a 10-year marketing exclusivity of the product within the European
Union. The Orphan Drug Program of the European Union should promote the
development of therapies for rare and serious illnesses.
www.mologen.com.
About MOLOGEN AG
MOLOGEN AG, a German biopharmaceutical company with headquarters in Berlin
specializes in the research and development of innovative medications on
the basis of DNA structures. The activities focus on numerous product
developments which are relevant to the immune system; on the one hand
vaccines against infectious diseases and on the other hand cancer
medications. MOLOGEN AG is globally one of the few biotechnology companies
with well tolerated DNA-based cancer treatment in the clinical development
phase.
The stocks of MOLOGEN AG are listed in the Prime Standard of the German
stock exchange (ISIN DE0006637200).
Memberships in associations:
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) and MOLOGEN(R) are registered trademarks of MOLOGEN AG.
MOLOGEN AG
PRESS SERVICE:
Prof. Peter W. Huebner
Head of Corporate Communications
Tel: +49 - 30 - 84 17 88 - 38
Tel: +49 - 30 - 84 17 88 - 50
huebner@mologen.com
INVESTOR RELATIONS:
Joerg Petrass
Tel: +49 - 30 - 84 17 88 - 13
Tel: +49 - 30 - 84 17 88 - 50
investor@mologen.com
External Investor Relations:
Kirchhoff Consult AG
Sebastian Bucher
T: +49 - 40 - 60 91 86 - 18
F: +49 - 40 - 60 91 86 -16
sebastian.bucher@kirchhoff.de
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..
End of Corporate News
21.11.2011 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
Language: English
Company: MOLOGEN AG
Fabeckstraße 30
14195 Berlin
Germany
Phone: 030 / 841788-0
Fax: 030 / 841788-50
E-mail: info@mologen.com
Internet: www.mologen.com
ISIN: DE0006637200
WKN: 663720
Listed: Regulierter Markt in Frankfurt (Prime Standard);
Freiverkehr in Berlin, Düsseldorf, Hamburg, München,
Stuttgart
End of News DGAP News-Service
147092 21.11.2011
Bewerten Sie diesen Artikel: (
0
Bewertungen)
