Futility analysis in PLIANT study completed and approved by the DSMB
August 18, 2014
PledPharma AB Company Announcement Futility analysis in PLIANT study completed and approved by the DSMB DSMB reports that the futility/safety analysis of the first 30 patients has been completed and that no negative impact on the anticancer effect of the chemotherapy drug has been observed. Stockholm, 2014-08-18 08:30 CEST (GLOBE NEWSWIRE) -- The analysis covers the first 30 patients in the study who have completed four treatment cycles with the chemotherapy mixture FOLFOX after pretreatment with either PledOx® or placebo. The analysis showed that PledOx did not weaken the anticancer effect of FOLFOX. The analysis was conducted and approved by the independent expert panel DSMB (Drug Safety and Monitoring Board). The PLIANT trial can thus proceed with recruitment of patients as planned. ”The safety analysis is important since there has been a concern that the PledOx drug may not only protect healthy cells but also cancer cells against the effects of chemotherapy. The DSMB has therefore had an extra focus on this during the analysis but no negative impact on the anti-cancer effect of the chemotherapy drug has been observed”, says CEO Jacques Näsström. Safety analyzes will be conducted after every additional 30 patients have undergone four treatment cycles with chemotherapy, after pretreatment with either PledOx or placebo. For further information, please contact: Jacques Näsström, CEO +46 737 13 09 79 [email protected] Michaela Gertz, CFO +46 709 26 17 75 [email protected] About PledPharma PledPharma is a Swedish pharmaceutical company that develops new therapies for the treatment of life threatening diseases. The initial objective is to develop a drug, PledOx®, which reduces severe side-effects associated with chemotherapy. The current market for supportive cancer care is some USD 10 billion. PledPharma also evaluates an existing medicines possibility to reduce the damage that occurs on the heart muscle when patients suffer from acute myocardial infarction. In addition to these projects, the company is also evaluating opportunities of using our technology platform in additional areas where there is a significant unmet medical need. PledPharma has the potential to offer patients valuable and unique treatments for serious life-threatening diseases where there is an opportunity for faster registration in the US through "breakthrough therapy" designation. This means that the company has the potential to offer shareholders a good return on their investment. 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
