PledPharma AB Company Announcement Go-ahead for PledPharma to start part 2 of the PLIANT study PledPharma has received approval from the DSMB (Drug Safety Monitoring Board, an independent panel of experts) to start the randomized part of the Phase IIb study PLIANT. The study will evaluate whether pretreatment with PledPharma's drug candidate PledOx® reduces serious side effects caused by the chemotherapy FOLFOX in patients treated for metastatic colorectal cancer. Stockholm, 2013-11-13 08:30 CET (GLOBE NEWSWIRE) -- The approval comes after the DSMB has analyzed the data from the first six patients enrolled in the study. With the green light to go-ahead, the second wider part of the PLIANT study (for details, see below) can start. First out are the centers in Sweden and the United States closely followed by Bulgaria, Denmark and Portugal. Thereafter Germany, Serbia and Georgia will follow. We expect that the majority of centers can begin enrolling patients in November / December. "It's very positive to have passed part 1 without any objections from the DSMB and to now be able to start part 2 of the study, where a greater number of centers in parallel can start recruiting patients. Furthermore, we are now also intensifying our work in the preparations for partnering," says Jacques Näsström, CEO of PledPharma. About PledOx® PledOx (calmangafodipir) is a compound that among other properties prevents severe 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 severe side-effects constitute a significant problem. The side-effects results in that the planned chemotherapy dose cannot 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 For further information please contact: Jacques Näsström, CEO +46 737 130979 [email protected] About PledPharma PledPharma is a Swedish specialty pharma company that develops PledOx® (calmangafodipir) 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
