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.”
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.
Prof. Peter W. Huebner
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