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The sixth patient in the first part of the PLIANT-study approved for continued dosing

October 15, 2013

PledPharma AB
Company Announcement

The sixth patient in the first part of the PLIANT-study approved for continued

PledPharma has been authorized by DSMB to continue dosing with PledOx in the
phase IIb study PLIANT. When the sixth patient has been treated with the third
dose and the DSMB once again concur, then the randomized part of the study with
126 patients from approximately 30 centers in Europe and the United States can
start. If everything goes according to plan, a decision by DSMB to start the
second part can be expected during the week commencing with November 11. 

Stockholm, 2013-10-15 08:30 CEST (GLOBE NEWSWIRE) -- 

DSMB has analyzed the test results from the sixth patient, which was enrolled
in the study two weeks ago. The study is now in the final phase of the first
part, the so-called dose-escalation part. With the approval to proceed with the
study, the sixth and last patient can continue to receive the second cycle of
the higher dose of PledOx. 

When all six patients have completed treatment, the data from this open part
will be analyzed and presented. The result from some 40 treatments with PledOx
is expected to be reported towards the end of the first quarter 2014. 

DSMB stands for Drug Safety Monitoring Board and is an independent panel of

For further information please contact:

Jacques Näsström, CEO PledPharma, phone +46 73 713 09 79

About PledOx®

PledOx (calmangafodipir) is a compound that among other properties prevents the
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 serious side-effects constitute a significant problem. The
side-effects results in that the planned chemotherapy dose can not 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 

About PledPharma
PledPharma is a Swedish specialty pharma company that develops PledOx® 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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