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Go-ahead for PledPharma to start part 2 of the PLIANT study

November 13, 2013

PledPharma AB
Company Announcement

Go-ahead for PledPharma to start part 2 of the PLIANT study

PledPharma has received approval from the DSMB (Drug Safety Monitoring Board,
an independent panel of experts) to start the randomized part of the Phase IIb
study PLIANT. The study will evaluate whether pretreatment with PledPharma's
drug candidate PledOx® reduces serious side effects caused by the chemotherapy
FOLFOX in patients treated for metastatic colorectal cancer. 

Stockholm, 2013-11-13 08:30 CET (GLOBE NEWSWIRE) -- 

The approval comes after the DSMB has analyzed the data from the first six
patients enrolled in the study. With the green light to go-ahead, the second
wider part of the PLIANT study (for details, see below) can start. First out
are the centers in Sweden and the United States closely followed by Bulgaria,
Denmark and Portugal. Thereafter Germany, Serbia and Georgia will follow. We
expect that the majority of centers can begin enrolling patients in November /

"It's very positive to have passed part 1 without any objections from the DSMB
and to now be able to start part 2 of the study, where a greater number of
centers in parallel can start recruiting patients. Furthermore, we are now also
intensifying our work in the preparations for partnering," says Jacques
Näsström, CEO of PledPharma. 

About PledOx®
PledOx (calmangafodipir) is a compound that among other properties prevents
severe side-effects of chemotherapy in cancer treatment. PledOx has been shown
to protect against "oxidative stress" - a condition in which the cell's most
important protection is not sufficient against the levels of reactive
oxygen/nitrogen species generated as a result of the chemotherapy treatment. By
mimicking the enzyme manganese superoxide dismutase (MnSOD), PledOx boosts the
cells endogenous protection and thereby prevents side-effects that otherwise
would arise as a result of the "oxidative stress". 

About colorectal cancer
Colorectal cancer is the third most common cancer related cause of death in the
western world. Annually 450,000 people become ill in colorectal cancer on the
seven largest markets in the western world. First line treatment in colorectal
cancer is a combination treatment called FOLFOX (FOLinate, 5-Fluorouracil
(5-FU), and OXaliplatin). FOLFOX gives rise to a better outcome than previous
treatments, but severe side-effects constitute a significant problem. The
side-effects results in that the planned chemotherapy dose cannot be
administered. Less than half of the patients do not receive the prescribed
dose. Consequently, there is a huge medical need to reduce the side-effects of

About the PLIANT-study
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. The dose-escalation part comprises of 6
patients (3 on low dose and 3 on high dose). Another 3 patients are evaluated
with FOLFOX in combination with the antibody Avastin. In the next part, the
randomized part, aiming at 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. For further details
please see 

For further information please contact:
Jacques Näsström, CEO

 +46 737 130979

About PledPharma
PledPharma is a Swedish specialty pharma company that develops PledOx®
(calmangafodipir) for prevention of severe chemotherapy-induced side effects in
cancer patients. Due to these side effects optimal treatment cannot be carried
out. The current market for supportive cancer care is some SEK 72 billion.
PledOx protects normal cells against oxidative stress. It belongs to a group of
compounds named lowMEM (low Molecular Enzyme Mimetics), and mimics the enzyme
Manganese SuperOxide Distmutase (MnSOD) – the most important endogenous
cellular protectant against devastating oxidative stress. Oxidative stress is a
condition caused by harmful oxygen/nitrogen molecules, e.g., as a result of
chemotherapy treatment. The company is also evaluating opportunities of using
PLED substances in other diseases. 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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