CytoTools AG

  • WKN: A0KFRJ
  • ISIN: DE000A0KFRJ1
  • Land: Deutschland

Nachricht vom 25.07.2014 | 10:48

CytoTools AG: Clinical development of wound healing drug DermaPro(R) progressing on schedule in Europe, with initial analysis offering indications that confirm data from Phase IIb


DGAP-News: CytoTools AG / Key word(s): Miscellaneous

25.07.2014 / 10:48

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Clinical development of wound healing drug DermaPro(R) progressing on
schedule in Europe, with initial analysis offering indications that confirm
data from Phase IIb

- "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(R) 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(R) in this approval study.

At a meeting held with experts from the BfArM in June 2014, the DermaPro(R)
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(R), 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


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Language:    English                                                     
Company:     CytoTools AG                                                
             Klappacher Str. 126                                         
             64285 Darmstadt                                             
             Germany                                                     
Phone:       +49 (0)6151-951 58 12                                       
Fax:         +49 (0)6151-951 58 13                                       
E-mail:      kontakt@cytotols.de                                         
Internet:    www.cytotools.de                                            
ISIN:        DE000A0KFRJ1                                                
WKN:         A0KFRJ                                                      
Listed:      Freiverkehr in Berlin, Düsseldorf, Stuttgart; Frankfurt in  
             Open Market (Entry Standard)                                
 
 
End of News    DGAP News-Service  
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279375 25.07.2014                                                      

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