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PledPharma’s patient study showing reduced number of serious adverse events in chemotherapy treatment published in scientific journal

January 20, 2012

PledPharma AB
Company Announcement

PledPharma’s patient study showing reduced number of serious adverse events in
chemotherapy treatment published in scientific journal

Stockholm, 2012-01-20 09:00 CET (GLOBE NEWSWIRE) -- 
PledPharma (STO:PLED) today announced that the detailed results from the
MANFOL-study in which the PLED-derivative mangafodipir’s preventive effect on
the severe side effects that patients experience during FOLFOX chemotherapy in
colorectal cancer have been published in a scientific journal*. In addition to
fewer serious adverse events, a reduced drop of white blood cells was observed.
These effects were statistically significant. 

During the 3 first of 12 planned chemotherapy cycles in the MANFOL study, 7
patients were randomized to receive mangafodipir and 7 to receive placebo. 5
serious adverse events (2 reductions of white blood cell count (neutropenia), 1
with sensory nerve disturbances (sensory neuropathy), 1 with nausea, 1 with
ileus) were observed in 4 patients in the placebo group, but none in the
mangafodipir group (p<0,05). The total number of white blood cells was
significantly higher in the mangafodipir group compared to the placebo group
(p<0,01) at the last treatment cycle. 

“The results in the MANFOL-study confirms our previous positive pre-clinical
results where side-effects caused by the chemotherapeutic agent oxaliplatin
significantly decreased when PLED-derivative was administrated prior to
oxaliplatin treatment. The combined documentation makes us very optimistic as
we continue the clinical program. We are in the final stages of the ongoing
preparatory work that precedes our phase IIb-study in colorectal cancer
patients and expect the study to start mid 2012”, says CEO Jacques Näsström. 

About PLED-derivatives

PLED-derivatives protect the body’s normal cells against oxidative stress,
which is a condition that occurs when harmful oxygen molecules (oxygen
radicals) are overproduced. Harmful oxygen molecules are produced in various
processes and are usually neutralized by the body’s cells. In different
diseases, e.g. chemotherapy treatment of cancer, cells can not manage this
which leads to the production of more harmful oxygen molecules than cells can
handle (oxidative stress). PLED-derivative reduces oxidative stress by
mimicking the naturally occurring enzyme superoxide dismutase. Side effects
induced by chemotherapy in cancer treatment often cause a reduction of the
planned chemotherapy dose, and may even lead to a discontinuation of the
treatment in the worst case scenario. 

The company’s primary focus is to document the preventive effects of the
PLED-derivative, PledOx®, on side effects induced by the chemotherapy
combination treatment FOLFOX (FOLinate, 5-Fluorouracil (5-FU), and OXaliplatin)
in colorectal cancer treatment. The recent results of a preclinical study
indicate that PledOx protects against white blood cell drop caused by

The clinical phase IIb study will be done in patients with advanced colorectal
cancer, in which FOLFOX is given for life supportive and palliative purposes.
The primary objective will be to evaluate the reduction of side effects related
to a reduction of white blood cells (i.e. neutropenia), and sensory nerve
disturbances (sensory neuropathy). 

For further information please contact:

Jacques Näsström, CEO, cell: +46 73 713 0979

Erik Kinnman, Investor relations, cell: +46 73 422 1540

About PledPharma

PledPharma is a Swedish specialty pharma company, which develops new treatments
of life threatening diseases. PledPharma currently runs two projects in
clinical development phase II with the patented drug substance class,
PLED-derivatives. The preventive effect of PLED-derivatives on adverse effects
of chemotherapy in colon cancer is examined in one trial. Another trial
investigates the ability of PLED-derivatives to reduce reperfusion injuries in
myocardial infarction patients undergoing percutaneous coronary intervention
(PCI). PLED-derivatives protect the body’s normal cells against oxidative
stress, which is a condition due to overproduction of free oxygen radicals.
PLED-derivatives have in previous pre-clinical trials been shown to protect
against oxidative stress. Moreover, the PLED-derivative mangafodipir protected
against the side effects of chemotherapy in colorectal cancer. PledPharma
(STO:PLED) is listed on NASDAQ OMX First North. Erik Penser Bankaktiebolag is
the Certified Adviser. For more information, please visit 

*First clinical experience with the MRI contrast agent and SOD mimetic
Mangafodipir as an Adjunct in Cancer Chemotherapy – a Translational Study.
J.O.G. Karlsson et al., Translational Oncology. 2012: (5) 1, 32-8.



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