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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

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 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



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Address: Klara Norra Kyrkogata 26, SE 111 22 Stockholm, Sweden

Phone: +46 8 679 72 10