PledPharma AB Company Announcement First patient included into PledPharma’s PLIANT study PledPharma announces today that the first patient has been enrolled in the phase IIb study, PLIANT. This study will evaluate PledPharma's drug candidate PledOx™ ability to reduce side effects caused by the chemotherapy FOLFOX in patients treated for metastatic colorectal cancer. Stockholm, 2013-02-12 21:02 CET (GLOBE NEWSWIRE) -- The Oncology clinic at Uppsala University Hospital has included the first patient in the study. This is one of four centers in Sweden and the United States that will include patients in the study's first part, the dose-escalation phase. - It is very positive to get started with the PLIANT study and we look forward with confidence to the first results from dose-escalation phase, says Dr. Bengt Glimelius, Professor at the Department of Oncology at Uppsala University Hospital and principal investigator of the PLIANT study. As a second step after the first dose-escalation phase is completed, which is expected to take approximately 4-5 months, the study will expand to include 126 patients from at least 28 centers in Europe and the U.S. - This study will demonstrate PledOx’s ability to reduce serious and some-times life-threatening side effects from chemotherapy. In this way, the patients will receive both a better quality of life, and hopefully an increased survival, says Jacques Näsström CEO PledPharma. Colorectal cancer is the third most common cancer-related cause of death in the Western world. Standard treatment for advanced colorectal cancer is the chemotherapy FOLFOX. However, serious and sometimes life-threatening side effects, such as pathological changes in white blood cell count and painful neurosensory disorders mainly in the hands and feet, lead to that fewer than half of the patients complete the treatment with the initial dose of chemotherapy. Depending on the side effect, a first step before reducing the dose is to postpone next dose chemotherapy once or several times. The side effects affect the patients' quality of life negatively with the risk of long-term symptoms even after stopping the treatment. About PledOx™ PledOx™ (calmangafodipir) is a compound that, among other things prevents the side effects of chemotherapy in cancer treatment. PledOx has been shown in studies to protect against "oxidative stress" - a condition in which the cell's most important protection is not sufficient against the levels of reactive oxygen species generated as a result of the chemotherapy treatment. By mimicking the enzyme superoxide dismutase (SOD), PledOx boosts the cells endogenous protection and thereby prevents side effects that would otherwise arise as a result of the "oxidative stress". About PLIANT-study PLIANT study is divided in two parts. A dose-escalation phase, in order to determine the correct dose level, and a randomized phase, with the goal to establish PledOx’s effect. The dose-escalation phase comprises of 9-12 patients from three selected medical centers in Sweden and one in the U.S. – the Oncology clinic at Uppsala University Hospital, Karolinska University Hospital, Department of Oncology, Linköping University Hospital and the Cancer Therapy & Research Center at The University of Texas Health Science Center in San Antonio , USA. Next phase, the randomized phase, planned for 126 patients from at least 28 centers in Europe and the United States, the patients will be divided into three equal groups to receive either placebo or PledOx in two different doses. For further details please see www.clinicaltrials.gov For further information please contact: Jacques Näsström, CEO +46 737 130979 [email protected] 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 further information, please visit www.pledpharma.se
