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First patient included into PledPharma’s PLIANT study

February 12, 2013

PledPharma AB
Company Announcement

First patient included into PledPharma’s PLIANT study

PledPharma announces today that the first patient has been enrolled in the
phase IIb study, PLIANT. This study will evaluate PledPharma's drug candidate
PledOx™ ability to reduce side effects caused by the chemotherapy FOLFOX in
patients treated for metastatic colorectal cancer. 

Stockholm, 2013-02-12 21:02 CET (GLOBE NEWSWIRE) -- The Oncology clinic at
Uppsala University Hospital has included the first patient in the study. This
is one of four centers in Sweden and the United States that will include
patients in the study's first part, the dose-escalation phase. 

- It is very positive to get started with the PLIANT study and we look forward
with confidence to the first results from dose-escalation phase, says Dr. Bengt
Glimelius, Professor at the Department of Oncology at Uppsala University
Hospital and principal investigator of the PLIANT study. 

As a second step after the first dose-escalation phase is completed, which is
expected to take approximately 4-5 months, the study will expand to include 126
patients from at least 28 centers in Europe and the U.S. 

- This study will demonstrate PledOx’s ability to reduce serious and some-times
life-threatening side effects from chemotherapy. In this way, the patients will
receive both a better quality of life, and hopefully an increased survival,
says Jacques Näsström CEO PledPharma. 

Colorectal 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.  However, serious and sometimes life-threatening side
effects, such as pathological changes in white blood cell count and painful
neurosensory disorders mainly 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, a first step before reducing the
dose is to postpone next dose chemotherapy once or several times. The side
effects affect the patients' quality of life negatively with the risk of
long-term symptoms even after stopping the treatment. 

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  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 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 a new medicine,
PledOx™, for prevention of the severe side effects that patients develop as a
consequence of chemotherapy treatment of cancer. Many times the treatment
cannot be carried out as planned due to very difficult side effects. The
current market for supportive cancer care is some SEK 72 billion. PledOx is a
medicine within the patent protected substance class PLED, which protects the
body’s normal cells against oxidative stress. Oxidative stress is a condition
where an overabundance of harmful oxygen molecules (free oxygen radicals) has
been formed. We are also evaluating opportunities with PLED substances for
other diseases. PledPharma (STO:PLED) is listed on NASDAQ OMX First North. Erik
Penser Bankaktiebolag is the Certified Adviser. For further information, please



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