Stockholm, 2014-09-09 08:00 CEST (GLOBE NEWSWIRE) --
The DSMB reports that the second futility analysis that includes an additional 30 patients has been completed and that no negative impact on the anticancer effect of the chemotherapy drug has been observed.
The analysis covers the first 60 patients in the study who have completed four treatment cycles with the chemotherapy mixture FOLFOX after pretreatment with either PledOx® or placebo. The approval means that PledOx did not weaken the anticancer effect of FOLFOX and that the PLIANT trial can thus proceed with recruitment of patients as planned.
In the PLIANT study the drug PledOx is tested to reduce serious side effects from FOLFOX treatment of colorectal cancer. Many chemotherapy treatments can't be completed as planned due to serious and life-threatening side effects. The primary objective with the PLIANT study is to evaluate the reduction of adverse events related to a decrease in white blood cells (neutrophils) and sensory nerve disorders (neuropathy).
Another futility analysis will be conducted after 90 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
Jacques.nasstrom@pledpharma.se
Michaela Gertz, CFO
+46 709 26 17 75
Michaela.gertz@pledpharma.se
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 fast 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
