• Treatment of final patients for three and four-month treatment periods now begun
• Results of phase III diabetic foot study in second half of 2015
• Interim analysis of study on ulcus cruris (venous leg ulcer) and decision by Data Safety and Monitoring Boards (DSMB) by July 2015
Darmstadt, 15 April 2015 All patients needed for the clinical phase III study on the wound healing drug DermaPro® for the diabetic foot (DFU) indication in Europe have now been successfully recruited. For this study, more than 300 patients have been recruited at 36 renowned European diabetics clinics in 7 countries. The three-month treatment period will be followed by an evaluation stage, enabling the study results to be presented in the second half of 2015.
This phase III study is intended to provide final proof of the effectiveness and compatibility of the drug for patients suffering from diabetic foot syndrome. Should the results be consistent with the superb results achieved to date, then European approval will subsequently be sought for the DermaPro product.
Chronic, poorly-healing wounds on legs and feet of the kind resulting in particular from diabetes represent an ever greater medical problem worldwide, one that has to be taken very seriously. According to studies performed by the “International Diabetes Federation”, the total number of people suffering from diabetes worldwide topped the 370 million mark in 2012. Well over 5 million people live with diabetes in Germany alone. Due to circulatory disorders and vasoconstriction, up to 20% of all diabetics contract diabetic foot. Not infrequently, this leads to amputations.
The patients needed for the interim evaluation of the clinical phase II/III study of the wound healing drug DermaPro for the ulcus cruris indication in Europe have also been included in the study. Once treatment of the final patients recruited for this study phase is complete, a blinded interim analysis will be performed by an independent body of experts. Should these experts reach a positive decision concerning the continuation of the study, then there is a very good chance that DermaPro will prove to be superbly effective for this indication as well. The area of application for the drug could then be extended to a very large group of patients.
This study involves a double-blinded multi-centric Phase II/III study for the wound healing drug DermaPro in the ulcus cruris indication. The study is intended to provide proof that DermaPro promotes and accelerates wound healing in the ulcus cruris illness, often referred to as venous leg ulcer, and that it will ideally lead to the complete healing of the chronic ulcer.
Venous leg ulcer is a painful, socially isolating and disabling illness mostly contracted by older people and affecting at least 5% of the population aged over 65.
There is a strong correlation between the chronicity and size of the ulcer and its probability of healing. For wounds larger than 10cm² and older than a year, the probability of the wound fully healing is less than 20%.
Comments Dr. Markus Weissbach, Chief Medical Officer at CytoTools: “The successful recruitment for these two clinical studies on DermaPro reflects patients’ need for an innovative drug for these chronic, poorly healing wounds. Should the results be positive, we will then apply for approval for DermaPro for both indications in Europe.”
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 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 (57%) and CytoPharma GmbH (42%).
Contact:
CytoTools AG
Dr. Mark Andre Freyberg
Klappacher Str. 126
64285 Darmstadt
Tel.: +49-6151-95158-12
Fax: +49-6151-95158-13
E-Mail: freyberg@cytotools.de
Press and Investor Relations:
Instinctif Partners
Dr. Robert Mayer/Dorothea Schneider
Rindermarkt 5
80331 Munich
Tel.: +49-89-3090 5189 13
E-Mail: cytotools@instinctif.com
Help employers find you! Check out all the jobs and post your resume.
• Results of phase III diabetic foot study in second half of 2015
• Interim analysis of study on ulcus cruris (venous leg ulcer) and decision by Data Safety and Monitoring Boards (DSMB) by July 2015
Darmstadt, 15 April 2015 All patients needed for the clinical phase III study on the wound healing drug DermaPro® for the diabetic foot (DFU) indication in Europe have now been successfully recruited. For this study, more than 300 patients have been recruited at 36 renowned European diabetics clinics in 7 countries. The three-month treatment period will be followed by an evaluation stage, enabling the study results to be presented in the second half of 2015.
This phase III study is intended to provide final proof of the effectiveness and compatibility of the drug for patients suffering from diabetic foot syndrome. Should the results be consistent with the superb results achieved to date, then European approval will subsequently be sought for the DermaPro product.
Chronic, poorly-healing wounds on legs and feet of the kind resulting in particular from diabetes represent an ever greater medical problem worldwide, one that has to be taken very seriously. According to studies performed by the “International Diabetes Federation”, the total number of people suffering from diabetes worldwide topped the 370 million mark in 2012. Well over 5 million people live with diabetes in Germany alone. Due to circulatory disorders and vasoconstriction, up to 20% of all diabetics contract diabetic foot. Not infrequently, this leads to amputations.
The patients needed for the interim evaluation of the clinical phase II/III study of the wound healing drug DermaPro for the ulcus cruris indication in Europe have also been included in the study. Once treatment of the final patients recruited for this study phase is complete, a blinded interim analysis will be performed by an independent body of experts. Should these experts reach a positive decision concerning the continuation of the study, then there is a very good chance that DermaPro will prove to be superbly effective for this indication as well. The area of application for the drug could then be extended to a very large group of patients.
This study involves a double-blinded multi-centric Phase II/III study for the wound healing drug DermaPro in the ulcus cruris indication. The study is intended to provide proof that DermaPro promotes and accelerates wound healing in the ulcus cruris illness, often referred to as venous leg ulcer, and that it will ideally lead to the complete healing of the chronic ulcer.
Venous leg ulcer is a painful, socially isolating and disabling illness mostly contracted by older people and affecting at least 5% of the population aged over 65.
There is a strong correlation between the chronicity and size of the ulcer and its probability of healing. For wounds larger than 10cm² and older than a year, the probability of the wound fully healing is less than 20%.
Comments Dr. Markus Weissbach, Chief Medical Officer at CytoTools: “The successful recruitment for these two clinical studies on DermaPro reflects patients’ need for an innovative drug for these chronic, poorly healing wounds. Should the results be positive, we will then apply for approval for DermaPro for both indications in Europe.”
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 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 (57%) and CytoPharma GmbH (42%).
Contact:
CytoTools AG
Dr. Mark Andre Freyberg
Klappacher Str. 126
64285 Darmstadt
Tel.: +49-6151-95158-12
Fax: +49-6151-95158-13
E-Mail: freyberg@cytotools.de
Press and Investor Relations:
Instinctif Partners
Dr. Robert Mayer/Dorothea Schneider
Rindermarkt 5
80331 Munich
Tel.: +49-89-3090 5189 13
E-Mail: cytotools@instinctif.com
Help employers find you! Check out all the jobs and post your resume.
