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The PLIANT study is fully recruited and the final futility analysis approved

October 21, 2014

PledPharma AB
Company Announcement

The PLIANT study is fully recruited and the final futility analysis approved

Stockholm, 2014-10-21 08:30 CEST (GLOBE NEWSWIRE) -- 
All 126 patients have now been included in PledPharma’s colorectal cancer study
PLIANT and results are expected by the end of Q1 next year. 

The DSMB reports that the third and last futility analysis that included 30
patients, in addition to those 60 patients already analyzed, has been completed
and that no negative impact on the anticancer effect of the chemotherapy has
been observed. 

The analysis covers the first 90 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 be concluded as planned. 

" We have now completed the recruitment for the PLIANT study. In the recent
months, the recruitment rate has been high and the last patient needed has been
included in Part 2 of the study. In total 165 patients have been randomized and
have initiated their treatment in the PLIANT study. These patients have in
total received more than 600 doses of PledOx to date. Our plan is to present
the overall study results at the end of the first quarter of 2015. The results
presented will include the effect of PledOx on FOLFOX induced peripheral
neuropathy and other dose-limiting side effects.  One important goal is to
demonstrate that PledOx does not negatively impair the anticancer effect.
Therefore, it is of particular importance that DSMB announced that no further
analysis needs to be carried out on the remaining patients", said CEO Jacques

About the PLIANT study

The PLIANT-study investigates PledOx’s ability to reduce serious FOLFOX-induced
side effects during treatment of colorectal cancer. The primary objective is to
evaluate the reduction of adverse events related to a decrease in white blood
cells (neutrophils) and sensory nerve disorders (neuropathy). The PLIANT study
is divided into two parts with an initial dose-escalation part, in order to
determine the correct dose-level, and a randomized part, with the goal to
establish PledOx’s effect. 

In the randomized part, aiming at roughly 126 patients from approximately 30
centers in Europe and the United States, the patients will be divided into
three equal groups to receive either placebo or PledOx in two different doses
(2 μmol/kg or 5 μmol/kg). For further details please see 

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



Contact us

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

Phone: +46 8 679 72 10