After extensive meeting, Indian regulatory authorities recommend registration of DermaPro®
Clinical phase III trial in Europe for diabetic foot indication shortly before unblinding and final evaluation
In the official protocol of the meeting, made available in October, the contents of the meeting and the positive results are confirmed. The commission gives a clear recommendation to grant permission for the market admission of DermaPro®, and to issue the necessary import approvals. Thus the prerequisites have been fulfilled to receive the approval document very soon and to launch the 'New Chemical Entity' DermaPro® in the large and important Indian market.
The application for registration was already submitted to the Indian authorities at the end of 2013 after Centaur had completed a phase III trial with 310 patients in which the excellent efficacy of DermaPro® was confirmed: Already after 10 weeks, the wound surfaces had at least halved for 92% of the patients, i.e. a continuing healing process had been initiated. For 76% of the patients, a complete closure of the chronic wounds could be achieved after 10 weeks. After the market launch, this new medication will finally be available for the millions of patients in India.
Our Partner, the Centaur Pharmaceuticals company, has already drawn up a detailed marketing concept which, among other measures, also includes scientific symposia in which the medical profession are to be informed about the innovations and the breakthrough in the treatment of chronic wounds.
As already reported, the treatment of patients has been completed in the corresponding European study on diabetic foot. Delays in data transfer from some Hungarian centres means that the data cleansing can be expected by mid November. The final results will be available by the end of November at the latest.
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.
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 (55%) and CytoPharma GmbH (42%).
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