Press release

 

Berlin, December 9, 2009 - MOLOGEN AG has applied to the responsible authorities and ethics committees in Germany and Austria to carry out a phase 2 clinical study with its cancer drug MGN1703 for the treatment of metastasized colorectal cancer. The application will also be extended to other European countries and Russia.

 

The randomized, placebo-controlled, double-blind, multicenter phase 2 clinical study (IMPACT study) is designed as a licensing-relevant confirmatory study and is intended to verify the efficacy of MGN1703 with statistical significance. The primary objective of the study is to determine the progression-free survival of the patients. Secondary objectives are to determine the overall survival of patients and the elucidation of immunological and pharmacodynamic parameters. A first projection on reaching the study objectives will be available after an interim evaluation only nine to ten months after starting the study. The study might take up to three years in all.

 

The study includes patients who have been treated only with standard chemo-immunotherapy as first-line therapy in the past. In contrast to the patients in the prior phase 1b study the immune system of the patients in this study will not have been previously damaged by multiple lines of therapy and higher tumor burden. It is expected that the patients will therefore respond even better to a treatment with MGN1703.

 

The cancer drug MGN1703 is a DNA-based immunomodulator that is being developed for DNA immunotherapy of patients with metastasized tumor diseases.

 

"Most likely we will be able to start the clinical Phase 2 study with our innovative cancer drug as soon as the first quarter of 2010. The study director, the investigating physicians, and the entire MOLOGEN team are pleased to be able to show the great efficacy potential with proven good tolerability of MGN1703 in the course of this licensing-relevant clinical study," says Dr. Marina Tschaika, Director of Clinical Development at MOLOGEN AG.

The Chairman of the Board Dr. Matthias Schroff explains: "The application for the clinical phase 2 study is an immensely important milestone for our company. When MGN1703 proves its efficacy in the study, which I assume it will, we will be able to contribute very soon an important component for improved treatment of cancer patients."

 

About the clinical study with MGN1703

The study is set up as a randomized, double-blind, placebo-controlled multicenter phase 2 study to examine the efficacy and safety of subcutaneously administered MGN1703 in the treatment of patients with metastasized cancer of the large intestine and rectum (IMPACT study). The dosage of MGN1703 is 60 mg, administered twice a week. The treatment will be continued until the disease progresses.

 

The primary endpoint is determination of the median progression-free survival of patients, based on radiological and clinical parameters. Secondary endpoints include the interpretation of responsiveness of the immune system, the pharmacodynamics, and the safety profile of MGN1703.

 

About MGN1703

MGN1703 is based on the immunomodulator dSLIM® ("Double Stem Loop Immunomodulator") developed by MOLOGEN, an innovative DNA-based TLR9 agonist. The use of dSLIM® activates the immune system against tumor-associated antigens, by targeting various receptors in certain immune cells, primarily TLR9. Tumor-associated antigens (TAA) are released by cancer cells as a result of chemotherapy and radiation therapy. The immune system activated by dSLIM® is able to overcome the fatal tolerance for cancer cells and TAA and to proceed selectively against them.

 

The results of clinical phase 1b studies already carried out show that MGN1703 has an excellent safety profile. Treatment with the investigational medicinal product has been tolerated well, and no dose-limiting and/or serious side effects have been found.

 

About metastasized colorectal cancer

Colorectal cancer is one of the most frequent cancer diseases worldwide, and is the second most frequent cause of death from cancer in western industrialized countries. The number of new cases of the disease, about 500,000 annually, is also one of the highest of all cancer indications.

 

Metastasized colorectal cancer is usually treated in first-line therapy with chemotherapy, combined with the antibodies Bevacizumab or Cetuximab, depending on the baseline condition of the patient. The standard combination therapy makes possible a substantial lengthening of progression-free survival of patients, but is accompanied by severe side effects and resistance problems, and thus detracts from the patient's quality of life. The median overall survival of patients who suffer from metastasized colorectal cancer amounts to about 20-23 months. The median progression-free survival for the first-line therapy amounts to about 9-10 months.