PledPharma’s PledOx® project moves forward according to plan
June 27, 2012
PledPharma AB Company Announcement PledPharma’s PledOx® project moves forward according to plan Stockholm, 2012-06-27 08:30 CEST (GLOBE NEWSWIRE) -- PledPharma (STO:PLED) today announced that the preparations ahead of the initiation of the phase IIb trial with PledOx® in colorectal cancer patients is moving forward as planned. A clinical trial application to the Swedish Medical Products Agency has been handed in and we expect an approval in August. Moreover, the opportunities to broaden the PledOx patent protection have been strengthened by a composition of matter patent application. The study has been procured in accordance with the budget at a contract research organization and we expect to recruit the first patient in the PledOx study during the third quarter 2012. Professor Bengt Glimelius will be the coordinating Principal Investigator of the study. Professor Glimelius, at Uppsala University Hospital, is a world authority within research and treatment of cancer, especially cancer in the gastrointestinal canal. About 120 patients will be recruited from several clinics in Europe and the US. We expect top line results in the end of 2013. The recent patent application is a composition of matter patent for PledOx, in which we describe an optimized “combination” of PLED substances in one molecule. The application also covers the manufacturing and medical use of PledOx and other similar substances. When these applications are approved, they will give us a broad protection at least until 2032. “We have in a successful manner and in accordance with plan delivered activities preparing the initiation of our exciting PledOx study. I am happy and proud about what we have achieved to date and am very much looking forward to the start of the study. We are also looking forward to working with very experienced and qualified clinics and investigators under the leadership of Professor Glimelius. In addition, we will strengthen our patent protection”, says CEO Jacques Näsström. For further information please contact: Jacques Näsström, CEO, cell: +46 73 713 0979 Erik Kinnman, Investor relations, cell: +46 73 422 1540 About PledPharma PledPharma is a Swedish specialty pharma company that develops a new medicine, PledOx®, for prevention of the severe side effects that patients develop as a consequence of chemotherapy treatment of cancer. Many times the treatment cannot be carried out as planned due to very difficult side effects. The current market for supportive cancer care is some SEK 72 billion. PledOx is a medicine within the patent protected substance class PLED, which protects the body’s normal cells against oxidative stress. Oxidative stress is a condition where an overabundance of harmful oxygen molecules (free oxygen radicals) has been formed. We are also evaluating opportunities with PLED substances for other diseases. PledPharma (STO:PLED) is listed on NASDAQ OMX First North. Erik Penser Bankaktiebolag is the Certified Adviser. For more information, please visit www.pledpharma.se
