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For patients
Thank you for using the following provided information for patients.
We would like to inform you about our clinical studies with the medications developed by MOLOGEN and at the same time introduce our research approach. We are doing this to make our clinical studies more transparent and to inform both you and physicians about the developments at MOLOGEN AG. At this point, we expressly point out that this website cannot replace advice from a doctor or act as any kind of medical recommendation. You, as a patient, should always obtain comprehensive medical advice before you make decisions in regards to your treatment.
So far, none of the medications developed by MOLOGEN AG have received approval from the medical authorities. This means that the medications can currently neither be prescribed nor purchased.
Some of the medications developed by MOLOGEN, however, are used for the treatment of patients within the scope of clinical studies.
MOLOGEN develops new therapies for cancer treatment
MOLOGEN AG focuses its research and development activities on illnesses for which there is a high medical demand: the treatment of cancer and the fight against serious infectious diseases.
The research approach MOLOGEN develops innovative medications and vaccines on the basis of the proprietary platform technologies MIDGE® and dSLIM®. Both technologies are based on DNA structures and, due to their special structure and complexity, they can be used in numerous medical applications – both for therapeutic and prophylactic uses.
With the cancer therapy dSLIM® and cell-based gene therapy, MOLOGEN AG follows two promising approaches that we would like to introduce to you at this point.
Cancer therapy with dSLIM® In a healthy organism, diseased cells are recognized and destroyed by the immune system. With cancer, this defense system no longer works, this means that the body develops a "tolerance” to the tumor cells. The cancer cells are no longer recognized by the immune system and thus, no defense reaction can occur. As a result, the cancer cells can multiply unresisted.
One of the greatest hopes in cancer research deals with finding a way to avoid this tolerance. A key role here is played by different antigens, which are found on the surface of tumor cells. If healthy cells mutate into cancer cells, so-called tumor associated antigens (TAA) are simultaneously formed; they are then expressed on the cell membrane of the tumor cell. If it is possible to influence the immune system to recognize these antigens, then there is hope that an improvement or even healing of the illness can be reached.
The biggest expectations in the area of immune therapies are found in substances that bond on certain receptors, so-called toll-like receptors (TLR). These receptors are components of the innate defense system. They are capable of facilitating the recognition of tumor-associated antigens by activating the immune system. Years of research have shown that particularly the toll-like receptor 9 (TLR9) plays a crucial role in fighting cancer. This is where the research from MOLOGEN is applied: with dSLIM®, the innovative TLR9 agonist developed by MOLOGEN, the invasion of pathogens is simulated. Through this, a wide activation of the immune system is achieved without actually causing an illness. Due to this activation, the immune system is able to recognize the tumor-associated antigens and thus, to fight the cancer cells on its own account.
Cell-based gene therapy against cancer With its cell-based gene therapy against cancer, MOLOGEN is pursuing another innovative approach to cancer treatment, which combines the complex platform technologies of MIDGE® and dSLIM® into a single product. Foreign cancer cells ( so-called allogeneic tumor cells) are used to activate the immune system in order to recognize and fight the patient’s own tumor cells. A prerequisite to that process is that a reaction to the allogeneic cancer cells was previously induced and the immune system learned what typical cancer cells look like. The mechanism of action for this therapeutic concept is based on inducing a cross-reaction of the patient’s immune system against the cancer cells that are produced by the body. The allogeneic tumor cells are genetically modified prior to their injection into the patient using MIDGE® vectors and are then combined with the immunomodulator dSLIM® as an immune booster (so-called adjuvant) in order to maximize the efficacy of this effect.
Cell-based gene therapy is a further promising approach to overcome the immune system's fatal tolerance towards the cancer cells.
Current status of the clinical studies
MGN1703 The cancer medication MGN1703, which shall cause the activation of the immune system based on dSLIM®, is being examined since the middle of June 2010 within the scope of a clinical phase II study. Phase 1, in which the safety and tolerability of the medication was inspected, was completed with a high degree of success: The clinical phase Ib study showed an excellent safety profile for MGN1703. Treatment with the investigational medicinal product was well tolerated and no dose-limiting or serious side-effects were identified. Very promising signs of efficacy were also found. MGN1703 was able to delay the progression of cancer diseases by at least 6 weeks in many cases, including patients with advanced metastatic tumor diseases with no further standard treatment options like the ones selected for the phase 1b study.
The phase II study will investigate the efficacy of MGN1703 in the treatment of patients with metastatic colorectal cancer. The study is being executed at multiple study centers under the guidance of Professor Hans Joachim Schmoll, Director of the
More information about MGN1703-CRC can be found under: http://www.mologen.com/data/Deutsch/03_03_Phase1.shtml
MGN1601 In June 2010, MOLOGEN AG received permission to conduct a phase I/II clinical study with the innovative cancer medication MGN1601 for the treatment of renal cancer. The open, non-randomized phase I/II clinical study shall examine the safety and efficacy of MGN1601 for the treatment of patients with advanced renal cancer. The primary aim of the study is to generate safety and tolerability data about the drug. In addition, efficacy data, including clinical, immunological and radiological parameters of the patients, will also be collected.
The study will be headed by PD Dr. Steffen Weikert, Urological Department Charité - Universitätsmedizin
More information about MGN1601 can be found under: http://www.mologen.com/data/Deutsch/03_04_01klinische_Studien.shtml
Information on the participation in clinical studies
If you would like further information about our clinical studies and/or the possibility of participating in a study, please contact our medical scientist and head of the clinical development department:
Dr. Marina Tschaika Phone (direct line) +49-30-84 17 88-284 Phone (secretariat) +49-30-84 17 88-0 Cell phone +49-163-84 17 888 Email: tschaika@mologen.com
About clinical studies
The execution of clinical studies is indispensible and legally prescribed for the research and development of new medications and therapies. The studies should offer conclusions as to whether this new medication or therapy can effectively treat illnesses, if its application is safe and whether or not it has the potential to improve the patient's quality of life.
All clinical studies are subject to strict laws and regulations. They are carefully monitored by the regulatory and advisory authorities of the respective states, the ethics committees and the institutions or hospitals in which the studies are conducted.
There are different so-called clinical phases (I-IV) within clinical studies; their division is based on the progress of the medication’s development.
Phase I: Investigation of the safety and tolerability of the medication for healthy subjects and/or patients (also known as "first-in-man")
Phase II: Investigation of the safety, tolerability and efficacy of the medication for patients; inspection of the therapy concept (“proof of concept”, phase IIa) and the ideal dosage (“dose finding”)
Phase III: Proof of efficacy and comparison with standard therapy (if available); large patient groups (at least 200 patients) are required in order to be able to make a statistically significant statement; if a therapeutic benefit is proven, a market admission can be applied for by the regulatory authorities.
Phase IV: Investigation of already marketed medications in regards to the possible side effects of the medication
Before an agent or product candidate can even be permitted to participate in a clinical phase I, it must have been subject to years of comprehensive, pre-clinical studies.
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