Ad-Hoc Announcement pursuant to Article 15 of the German Securities Trading Act (WpHG)

 

Successful clinical application of PVP hypericin in the fluorescence diagnosis of bladder cancer

• Phase II study proceeds on track  

 

Vienna, 12 February 2010 – Sanochemia Pharmazeutika AG, listed in the Prime Standard of the Frankfurt Stock Exchange (ISIN AT 0000776307), today announces the first results from a Phase II clinical trial investigating the use of PVP hypericin in the fluorescence diagnosis of superficial tumours in the bladder (PDD):

PVP hypericin has recently been made available for intravesical application in man. Encouraging data obtained in animal models which provided the motivation for developing the substance further have now been confirmed by the initial results from a Phase II clinical trial in human patients - namely the outstanding staining characteristics of Sanochemia’s PVP hypericin in the human bladder.

Based on the current status of the findings, PVP hypericin exhibits at least as effective, partially better, staining properties with respect to bladder tumours than the only other substance approved in this indication, hexaminolevulinate. Furthermore, the instillation times for PVP hypericin prior to the endoscopy appeared to be shorter, something which would be a clear advantage for patients.

This clinical trial, being performed in the urology clinic of the university hospital rechts der Isar of Munich Technical University, is the first to rely on a digital image analysis procedure for measuring the intensity of fluorescence. The subjective impression previously reported by an investigator is therefore replaced by objective values, a factor which itself sets a new benchmark in the photodynamic diagnosis of bladder cancer. Sanochemia expects to receive the closing report from the trial in the third quarter of 2010.

Photodynamic diagnosis is both a precondition for the high sensitivity diagnosis of superficial bladder cancer as well as being necessary in order to be able to regularly monitor patients endoscopically following successful treatment. Bladder carcinomas have a high tendency to recur. This could entail considerable revenue potential for this novel, high quality diagnostic procedure based on Sanochemia’s PVP hypericin. The global turnover in the area of bladder cancer diagnosis amounts to approximately USD 700 million and is increasing at a double-digit growth rate. The USA and Europe are currently the most important sales markets.

 

For further information please contact:

Margarita Hoch

Investor Relations 
Tel. : +43 / 1 / 3191456 / 335
Fax:  +43 / 1 / 3191456/ 344 

m.hoch(at)sanochemia.at