Phase I clinical study with cancer medicine MGN1703

 

After successful conclusion of all preclinical studies, a phase I clinical study with the innovative cancer medicine MGN1703 started on July 16, 2008 with the admission of the first patient. The study is being conducted at the cancer centers of the university hospitals in Essen and Cologne and will last about six months. In addition to safety and tolerability, the study will also examine the immunological effect of MGN1703 in the treatment of various cancer types. The start of this study marks an important milestone on the way to establishing MGN1703 as a safe and effective medicine for treating the most common cancerous diseases.

 

Important information for patients:

We kindly ask all patients who are interested in participating in this study to directly contact their attending physician. Thank you.

 

General information about clinical studies

 

For the development of new medicines and therapies, clinical studies are essential and prescribed by law. The studies are designed to provide an insight into whether these new medicines or therapies can effectively treat diseases, whether they are safe, and whether they are able to improve the patients' quality of life. All clinical studies are subject to stringent laws and regulations. They are carefully monitored by the regulatory and approval authorities of the respective states, the ethics commissions and the institutions or hospitals in which the studies are conducted. Clinical studies are classified by so-called clinical phases (I-IV) which are defined according to the development progress of the new medicine.

 

Phase I:	Study regarding safety and tolerability of the medicine in healthy volunteers
	and/or patients (also known as "first-in men" )
Phase II:	Study regarding safety, tolerability and efficacy of the medicine in patients;
	review of the therapeutic concept ( "proof of concept" , Phase IIa) and the
	suitable dose ("dose finding" , Phase IIb)
Phase III:	Proof of efficacy and comparison with the 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, marketing authorization may be applied for
Phase IV	Study in regards to possible side effects of medicines already approved for
	the market; these studies are also often used for marketing purposes

 

Before a medicinal product candidate can even be approved for a clinical phase I, it must already have undergone many years of extensive preclinical studies.

 

For further information please contact:
 Arlett Killat

 

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