The sixth patient in the first part of the PLIANT-study approved for continued dosing
October 15, 2013
PledPharma AB Company Announcement The sixth patient in the first part of the PLIANT-study approved for continued dosing PledPharma has been authorized by DSMB to continue dosing with PledOx in the phase IIb study PLIANT. When the sixth patient has been treated with the third dose and the DSMB once again concur, then the randomized part of the study with 126 patients from approximately 30 centers in Europe and the United States can start. If everything goes according to plan, a decision by DSMB to start the second part can be expected during the week commencing with November 11. Stockholm, 2013-10-15 08:30 CEST (GLOBE NEWSWIRE) -- DSMB has analyzed the test results from the sixth patient, which was enrolled in the study two weeks ago. The study is now in the final phase of the first part, the so-called dose-escalation part. With the approval to proceed with the study, the sixth and last patient can continue to receive the second cycle of the higher dose of PledOx. When all six patients have completed treatment, the data from this open part will be analyzed and presented. The result from some 40 treatments with PledOx is expected to be reported towards the end of the first quarter 2014. DSMB stands for Drug Safety Monitoring Board and is an independent panel of experts For further information please contact: Jacques Näsström, CEO PledPharma, phone +46 73 713 09 79 About PledOx® PledOx (calmangafodipir) is a compound that among other properties prevents the side-effects of chemotherapy in cancer treatment. PledOx has been shown to protect against "oxidative stress" - a condition in which the cell's most important protection is not sufficient against the levels of reactive oxygen/nitrogen species generated as a result of the chemotherapy treatment. By mimicking the enzyme manganese superoxide dismutase (MnSOD), PledOx boosts the cells endogenous protection and thereby prevents side-effects that otherwise would arise as a result of the "oxidative stress". About colorectal cancer Colorectal cancer is the third most common cancer related cause of death in the western world. Annually 450,000 people become ill in colorectal cancer on the seven largest markets in the western world. First line treatment in colorectal cancer is a combination treatment called FOLFOX (FOLinate, 5-Fluorouracil (5-FU), and OXaliplatin). FOLFOX gives rise to a better outcome than previous treatments, but serious side-effects constitute a significant problem. The side-effects results in that the planned chemotherapy dose can not be administered. Less than half of the patients do not receive the prescribed dose. Consequently, there is a huge medical need to reduce the side-effects of FOLFOX. About the PLIANT-study The PLIANT-study is divided into two parts with an initial dose-escalation part, in order to determine the correct dose level, and a randomized part, with the goal to establish PledOx’s effect. The dose-escalation part comprises of 6 patients (3 on low dose and 3 on high dose). Another 3 patients are evaluated with FOLFOX in combination with the antibody Avastin. In the next part, the randomized part, aiming at 126 patients from approximately 30 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 About PledPharma PledPharma is a Swedish specialty pharma company that develops PledOx® for prevention of severe chemotherapy-induced side effects in cancer patients. Due to these side-effects optimal treatment cannot be carried out. The current market for supportive cancer care is some SEK 72 billion. PledOx protects normal cells against oxidative stress. It belongs to a group of compounds named lowMEM (low Molecular Enzyme Mimetics), and mimics the enzyme Manganese SuperOxide Distmutase (MnSOD) – the most important endogenous cellular protectant against devastating oxidative stress. Oxidative stress is a condition caused by harmful oxygen/nitrogen molecules, e.g., as a result of chemotherapy treatment. The company is also evaluating opportunities of using PLED substances in 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
