PLIANT study starts in the U.S.
January 30, 2013
PledPharma AB Company Announcement PLIANT study starts in the U.S. PledPharma expands recruitment to the dose-escalation phase of PLIANT study with center in the U.S. Stockholm, 2013-01-30 10:55 CET (GLOBE NEWSWIRE) -- To increase recruitment, the study will also include the Cancer Therapy & Research Center at The University of Texas Health Science Center at San Antonio., U.S. for the first part of the study, the dose-escalation phase, together with the three centers in Sweden. On January 18, 2103, PledPharma received an Investigational New Drug (IND) approval from the FDA to conduct its Phase IIb study PLIANT in the U.S. The purpose of the PLIANT study is to investigate PledPharma’s drugs in development, PledOx™, for the ability to reduce the side effects caused by treatment with the chemotherapy FOLFOX in patients with metastatic (spread) colorectal cancer. ”We are excited about evaluating a substance class that in earlier studies has shown promising results in reducing dose-limiting side-effects of chemotherapy,” said Devalingam Mahalingam, M.D., Ph.D., an oncologist at the Cancer Therapy & Research Center at The University of Texas Health Science Center at San Antonio. “If this study shows positive results, it could mean a significant improvement for the large number of patients being treated for the disease,” Dr. Mahalingam said. Swedish MPA approves amendment of PLIANT study in Sweden The Swedish Medicinal Products Agency (MPA) has also recently given its approval for expanding the patient base in the PLIANT study. Now the inclusion criteria include patients receiving FOLFOX also in the second and third line settings. PledPharma applied for a broadening of inclusion criteria because the PLIANT study initially only aimed for treatment in the first line setting with FOLFOX. "We appreciate that the FDA and the MPA quickly gave the authorization. This means that significantly more patients can be recruited to the PLIANT study in hopefully less time,” said Jacques Näsström, CEO PledPharma. PLIANT study The PLIANT study is divided in two parts. The first part is a dose-escalation phase in order to determine the correct dosage level directly followed by a randomized phase with the purpose of establishing PledOx’s effect. In the dose-escalation phase, 6-9 patients are included from three selected medical centers in Sweden, Uppsala University Hospital, Karolinska University Hospital, Solna and Linköping University Hospital. The Cancer Therapy & Research Center at The University of Texas Health Science Center in San Antonio, Tx, USA, will contribute also to the 6-9 patients without bevacizumab as well as add three more in the high dose PledOx in pretreatment of FOLFOX in combination with bevacizumab. In 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 receiving either placebo or PledOx in two different doses. For further details see www.ClinicalTrials.gov . For further information please contact: Jacques Näsström, CEO +46 737 130979 Jacques.email@example.com 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