- “Diabetic foot”: More than 200 patients accepted into study for current Phase III indication trials
- Independent “Data Safety and Monitoring Board” (DSMB) recommends continuing Phase III study as planned, offering a clear indication that the good results achieved in Phase IIb have been confirmed
- In a scientific consultation, experts at the Federal Institute for Drugs and Medical Devices (BfArM) basically confirm the development plan for the DermaPro® wound healing solution
- Ulcus cruris (leg ulcer): Phase II/III study for the indication started, with patients being screened and recruited
Darmstadt (Germany), July 25, 2014 – DermaTools Biotech GmbH, a subsidiary of CytoTools AG, is very satisfied with the scheduled progress being made with the 2013 launched Phase III study for the “diabetic foot” indication. More than 200 patients have already been accepted into the therapeutic phase of the study in Germany and other European countries. An initial blinded interim analysis based on data evaluated for the first 80 patients completing the study was performed by an independent DSMB on July 23, 2014. The DSMB recommends continuing the study without change. This can be deemed a clear indication that the good results achieved in the European Phase 2b study have been confirmed. An unblinded interim analysis is expected once treatment of the first 160 patients has been completed in the 4th quarter. Here, it will already be possible to provide indications as to the expected effectiveness of DermaPro® in this approval study.
At a meeting held with experts from the BfArM in June 2014, the DermaPro® development plan for achieving approval was basically confirmed. No requirements were stipulated or objections raised that could delay submission of the application for approval in Europe planned for 2015.
Ulcus cruris (leg ulcer)
In parallel, the European clinical Phase II/III for the ulcus cruris indication has begun and the first patients are being recruited. This study is also progressing on schedule. Upon submission, it will be available as a second approval-relevant study. This way, it should be possible to achieve approval for two indications in Europe at the same time.
“Overall, we are currently very satisfied with the progress made with our clinical development program”, remarked Dr. Markus Weissbach, Chief Medical Officer at CytoTools AG. “Clinical development of medical drugs sometimes harbors surprises, but we have managed to avoid these so far. This is due not only to the ongoing excellent safety profile of DermaPro®, but also to the increasing confidence our investigating physicians are placing in the superb effectiveness of our substance and its uncomplicated application”, commented Dr. Weissbach in a statement.
This press release 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 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 (57%) and CytoPharma GmbH (42%).
Contact:
CytoTools AG
Dr. Mark Andre Freyberg
Klappacher Str. 126
D-64285 Darmstadt
Tel.:+49-6151-95158-12
Fax:+49-6151-95158-13
E-Mail: freyberg@cytotools.de
Press and IR contact:
Instinctif Partners
Dr. Robert Mayer/Dorothea Schneider
Rindermarkt 5
80331 Munich
Tel.: +49-89-3090 5189 13
E-Mail: cytotools@instinctif.com
Handelsregister des Amtsgerichts Köln (HRB 50 319) Ust.-Id. DE 227 065 314
Geschäftsführer: Ulrich Stockheim, Carsten Böhme
http://www.instinctif.de/
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