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Go-ahead for PledPharma to proceed with PLIANT study patient recruitment

February 26, 2013

PledPharma AB
Company Announcement

Go-ahead for PledPharma to proceed with PLIANT study patient recruitment

PledPharma has received green light from the DSMB (Drug Safety Monitoring
Board), an independent panel of experts) to continue patient recruitment for
the phase IIb study PLIANT. The study will evaluate whether pretreatment with
PledPharma's drug candidate PledOx™ reduces the severe side effects caused by
the chemotherapy FOLFOX in patients treated for metastatic colorectal cancer. 

Stockholm, 2013-02-26 09:42 CET (GLOBE NEWSWIRE) -- DSMB has analyzed the test
results from the first patient that was enrolled in the study two weeks ago.
The study is in the initial stage, the so-called dose-escalation phase. The
dosages of PledOx follow a strict protocol for when evaluating a new compound
for the first time in a clinical trial. With the approval to proceed with the
study, the first patient is to receive the second dose of PledOx, while the
next two patients to be included in the study in parallel can receive the first
low dose of PledOx. When all three patients received at least one cycle of
therapy, and the first patient received three cycles DSMB will re-evaluate the
data to give approval for this procedure to be repeated for the higher dose of

It is the Department of Oncology at Uppsala Academic Hospital which has
included the first patient in PLIANT study. This is one of four centers in
Sweden and the United States that include patients for dose-escalation phase.
As a second step after the dose-escalation phase is completed, which is
expected to take approximately 4-5 months, the study will be scaled up and
include 126 patients from at least 28 centers in Europe and the U.S. 

About PledOx™

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

About colorectal cancer

Colon cancer is the third most common cancer-related cause of death in the
Western world. Standard treatment for advanced colorectal cancer is the
chemotherapy FOLFOX but severe and sometimes life-threatening side effects such
as reductions in the white blood cell count and painful peripheral sensory
nerve disorders especially in the hands and feet, lead to that fewer than half
of the patients complete the treatment with the initial dose of chemotherapy.
Depending on the side effect, the first step before reducing the chemotherapy
dose is to postpone next dose once or several times. The adverse events affect
the patients' quality of life negatively, with the risk of long-term symptoms
even after stopping treatment. 

About PLIANT-study

PLIANT study is divided in two parts, a dose-escalation phase, in order to
determine the correct dose level and a randomized phase with the goal to
establish PledOx’s effect. The dose-escalation phase comprises of  9-12
patients from three selected medical centers in Sweden and one in the U.S. –
the Oncology clinic at Uppsala University Hospital, Karolinska University
Hospital, Department of Oncology, Linköping University Hospital and the Cancer
Therapy & Research Center at The University of Texas Health Science Center in
San Antonio, USA. Next phase, the randomized phase, planned for 126 patients
from at least 28 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 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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