PledPharma’s PledOx® safety studies positive
July 6, 2012
PledPharma AB Company Announcement PledPharma’s PledOx® safety studies positive Stockholm, 2012-07-06 08:30 CEST (GLOBE NEWSWIRE) -- PledPharma (STO:PLED) today announced positive results from its PledOx® long term pre-clinical safety studies. No unwanted effects on vital organs were detected. The final results have been an important part of the preparations ahead of the phase IIb PledOx study initiation in colorectal cancer patients, and an important part of the PledOx documentation for clinical trial applications. Potential effects of high intravenous doses of PledOx on vital organs (central nervous system, cardiovascular and respiratory system) were evaluated in pre-clinical safety studies. PledOx was given 3 times weekly for 3 months. Total doses were up to more than 185-fold the maximal proposed clinical dose. No effects on blood pressure, heart rate or electrocardiogram (ECG) were observed. The neurologic evaluations did not show any functional changes in the central or peripheral nervous system. Finally, no effects on the respiratory system were noted. “The positive results from these very important complementary long term pre-clinical safety studies validate the use of PledOx as intended in repeated dosing. We have previously shown that PledOx is safe in a shorter pre-clinical safety study, and we know that the clinically used pharmaceutical it originated from does not have clinical safety concerns”, 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
