MOLOGEN AG: First evaluation data on clinical trial with MGN1601 ? results for renal cancer therapy considerably better than anticipated

- Compound shows very good tolerability and safety
- Efficacy data much better than expected

Berlin, 29th August 2011 – Today, MOLOGEN AG published the first results from the phase I/II clinical trial with the cell-based renal cancer therapy MGN1601. The primary goal of this study is the investigation of safety and tolerability of the medicament.

According to the investigators safety and tolerability has to be assessed as very positive up to now. The tolerability of MGN1601 proved to be very good without exception. No adverse events that could be classified as serious were observed. Only in singular cases did patients report fatigue or mild fever; signs that might rather indicate activation of the immune system.

In addition, the first efficacy data have been collected using clinical, immunological and radiological patient parameters.
These are very promising: for example, two patients have responded in part very well to the cell-based cancer therapy MGN1601. In one case, progress of the renal cancer was halted and in the case of the other patient, the size of the metastases was reduced by more than 50 %.

At the same time the state of health of the patients is a challenge: the trial only accepts patients whose tumor growth could not be halted with medicaments that are currently available. The patients are initially treated with MGN1601 over a time period of three months. Those patients who respond to the treatment with MGN1601 are treated further during an extension phase. The clinical trial will be conducted at three study centers in Berlin, Hanover and Bonn.

“I am very pleased that two patients have responded so positively to our innovative cell-based cancer therapy. Of course, these are isolated cases in the first instance. But they are incredible, because in this study we are solely dealing with seriously ill people for whom, often after very long courses of therapy, the currently available meds are no longer showing any effect”, comments Dr. Matthias Schroff, CEO of MOLOGEN AG, on the intermediate results. “We are therefore optimistic about the further progress of the trial. At the same time, we will continue to plan a more in depth clinical trial to confirm the efficacy of MGN1601.”

Following the presentation last year of very promising efficacy data for the DNA cancer therapy MGN1703, collected during a phase Ib clinical trial, the cell-based cancer therapy MGN1601 is now also showing the first very good efficacy data. As the leading research company in DNA medicine and cell-based medicine, MOLOGEN AG is thus consistently pursuing its goal of developing highly-effective and safe medicaments for the treatment of cancer.

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® DNA vectors with additional genetic information and combined with MOLOGEN's own DNA immune modulator dSLIM® 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.


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®, dSLIM® and MOLOGEN® 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:

MOLOGEN AG
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
Janina Schumann M.A.
T: +49 - 40 - 60 91 86 - 50
F: +49 - 40 - 60 91 86 -16
janina.schumann@kirchhoff.de


 

Posted: August 2011

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