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The second futility analysis in the PLIANT study completed and approved

September 9, 2014

PledPharma AB
Company Announcement

The second futility analysis in the PLIANT study completed and approved

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

Michaela Gertz, CFO

+46 709 26 17 75

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



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Phone: +46 8 679 72 10