DermaTools Biotech GmbH starts the new European clinical trial for the wound healing medication DermaPro® on the diabetic foot syndrome indication

  • Application documents submitted for a clinical trial on the diabetic foot syndrome indication

  • Up to 200 patients to be treated at 15 prestigious European centers

  • Patient recruiting will most probably be completed already in 2018

Darmstadt, 21st December 2017 - With the submission of the application documents for the approval of a dose-finding clinical study, the DermaTools Biotech GmbH, a subsidiary of the CytoTools AG, has taken an important step in the further development of their wound healing active substance DermaPro®.

In this trial, evidence should be provided for the optimum dosage, regarding efficacy and tolerance of the active substance, for patients with diabetic foot syndrome. In this connection, the corresponding application documents were submitted to the responsible local health authorities.

Within the scope of this study designed for implementation on a European scale, up to 200 patients are to be treated at 15 prestigious European centers.

With the results of this dose-finding study, and the immediately following pivotal phase III trial, a robust and reliable data base should established for a successful new drug registration. With the corresponding results of the planned dose-finding study, and the subsequent phase III trial, this could lead to a direct registration application and the market launch in Europe.

Chronic and poorly healing wounds on the legs and feet, as often occur as a result of diabetes (diabetic foot syndrome), are a very serious medical problem which is increasing worldwide.

According to recent surveys by the "International Diabetes Federation", the total number of diabetics worldwide in 2016 exceeded the figure of 380 million people. In Germany alone, there are 6 million diabetics.

In order to finance the clinical trials, the CytoTools AG has concluded a framework agreement with the American investor Yorkville Advisors Global. Under the agreement, up to 15 million euros will be available over three years. With this, all clinical plans can be realized without further delay. Dr. Dirk Kaiser added: "At last, the important clinical program for the new drug development of DermaPro ® by the DermaTools Biotech GmbH in Europe can be restarted. We are confident that the results will provide us with in a new drug approval in Europe, corresponding to the NDA for India."

This information contains specific future oriented statements. These reflect the opinion of CytoTools on the date of this release. The actual results achieved by CytoTools could substantially deviate from the future-oriented statements made. CytoTools is not obligated to update these future-oriented statements.

About CytoTools

CytoTools AG is a German biotechnology company focused on translating fundamental biology research on the mechanisms of cell growth and programmed cell death into unique therapies that are designed to treat the cause of the disease rather than the symptoms. The Company has developed a robust and diverse pipeline of disease modifying therapies that comprise proprietary small molecules and biologics. These have the potential to provide new treatment options in dermatology, cardiology and angiology, urology and oncology. CytoTools AG is structured as an investment and holding company and as such holds investments in its subsidiaries DermaTools Biotech GmbH (58%) and CytoPharma GmbH (47%).

Contact:

CytoTools AG

Dr. Mark-André Freyberg Klappacher Str. 126 D-64285 Darmstadt

Tel.: +49-6151-95158-12 Fax: +49-6151-95158-13 E-Mail:freyberg@cytotools.de

CytoTools AG published this content on 07 February 2018 and is solely responsible for the information contained herein.
Distributed by Public, unedited and unaltered, on 07 February 2018 09:29:08 UTC.

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