PledPharma AB Company Announcement PledPharma’s patient study showing reduced number of serious adverse events in chemotherapy treatment published in scientific journal Stockholm, 2012-01-20 09:00 CET (GLOBE NEWSWIRE) -- PledPharma (STO:PLED) today announced that the detailed results from the MANFOL-study in which the PLED-derivative mangafodipir’s preventive effect on the severe side effects that patients experience during FOLFOX chemotherapy in colorectal cancer have been published in a scientific journal*. In addition to fewer serious adverse events, a reduced drop of white blood cells was observed. These effects were statistically significant. During the 3 first of 12 planned chemotherapy cycles in the MANFOL study, 7 patients were randomized to receive mangafodipir and 7 to receive placebo. 5 serious adverse events (2 reductions of white blood cell count (neutropenia), 1 with sensory nerve disturbances (sensory neuropathy), 1 with nausea, 1 with ileus) were observed in 4 patients in the placebo group, but none in the mangafodipir group (p<0,05). The total number of white blood cells was significantly higher in the mangafodipir group compared to the placebo group (p<0,01) at the last treatment cycle. “The results in the MANFOL-study confirms our previous positive pre-clinical results where side-effects caused by the chemotherapeutic agent oxaliplatin significantly decreased when PLED-derivative was administrated prior to oxaliplatin treatment. The combined documentation makes us very optimistic as we continue the clinical program. We are in the final stages of the ongoing preparatory work that precedes our phase IIb-study in colorectal cancer patients and expect the study to start mid 2012”, says CEO Jacques Näsström. About PLED-derivatives PLED-derivatives protect the body’s normal cells against oxidative stress, which is a condition that occurs when harmful oxygen molecules (oxygen radicals) are overproduced. Harmful oxygen molecules are produced in various processes and are usually neutralized by the body’s cells. In different diseases, e.g. chemotherapy treatment of cancer, cells can not manage this which leads to the production of more harmful oxygen molecules than cells can handle (oxidative stress). PLED-derivative reduces oxidative stress by mimicking the naturally occurring enzyme superoxide dismutase. Side effects induced by chemotherapy in cancer treatment often cause a reduction of the planned chemotherapy dose, and may even lead to a discontinuation of the treatment in the worst case scenario. The company’s primary focus is to document the preventive effects of the PLED-derivative, PledOx®, on side effects induced by the chemotherapy combination treatment FOLFOX (FOLinate, 5-Fluorouracil (5-FU), and OXaliplatin) in colorectal cancer treatment. The recent results of a preclinical study indicate that PledOx protects against white blood cell drop caused by oxaliplatin. The clinical phase IIb study will be done in patients with advanced colorectal cancer, in which FOLFOX is given for life supportive and palliative purposes. The primary objective will be to evaluate the reduction of side effects related to a reduction of white blood cells (i.e. neutropenia), and sensory nerve disturbances (sensory neuropathy). 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, which develops new treatments of life threatening diseases. PledPharma currently runs two projects in clinical development phase II with the patented drug substance class, PLED-derivatives. The preventive effect of PLED-derivatives on adverse effects of chemotherapy in colon cancer is examined in one trial. Another trial investigates the ability of PLED-derivatives to reduce reperfusion injuries in myocardial infarction patients undergoing percutaneous coronary intervention (PCI). PLED-derivatives protect the body’s normal cells against oxidative stress, which is a condition due to overproduction of free oxygen radicals. PLED-derivatives have in previous pre-clinical trials been shown to protect against oxidative stress. Moreover, the PLED-derivative mangafodipir protected against the side effects of chemotherapy in colorectal cancer. 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 *First clinical experience with the MRI contrast agent and SOD mimetic Mangafodipir as an Adjunct in Cancer Chemotherapy – a Translational Study. J.O.G. Karlsson et al., Translational Oncology. 2012: (5) 1, 32-8. http://www.transonc.com/pdf/manuscript/v05i01/neo11277.pdf
