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Positive data from the first part of the PLIANT study

February 12, 2014

PledPharma AB
Company Announcement

Positive data from the first part of the PLIANT study

As expected, the results from the first part of the PLIANT study show that
PledOx® was well tolerated by patients treated with FOLFOX chemotherapy. 

Treatment with FOLFOX often causes severe painful sensory disorders known as
neuropathies. These severe side-effects did not occur in patients who were
pre-treated with PledOx. The lower dose of PledOx also indicated a reduction of
serious white blood cell-related side effects. 

Stockholm, 2014-02-12 08:30 CET (GLOBE NEWSWIRE) -- The first part of the
study, the dose-escalation part (with PledOx® 2 and 10 μmol/kg) in order to
determine tolerability and the correct dose level, has been completed. 

The conclusion from the first part of the study is that the patients have
tolerated both doses of PledOx well. 

The raw data from the dose-escalation part have now been compiled in a
preliminary analysis. One can observe that, unlike during normal FOLFOX
treatment of colorectal cancer, no moderate or serious neuropathies (grade 2 or
higher) were observed despite up to 8 cycles of FOLFOX. This was seen for both
doses of PledOx. The expected outcome without PledOx-treatment is that
approximately 30% of the patients will develop neuropathies of grade 2 or worse
after 8 cycles. 

“What impresses most on the oncologists that we have talked to was the fact
that PledOx seems to reduce the risk of chemotherapy induced sensory nerve
disorders known as neuropathies. The reason for this being that chemotherapy
induced neuropathy is a major clinical problem and the main reason for
discontinuing oxaliplatin-based chemotherapy" says CEO Jacques Näsström. 

In addition, it seems that the low dose in particular appears to have the
potential to reduce serious (grade 3) white blood-related side effects such as
decrease in neutrophils. Neutrophils are an essential type of white blood cells
in defending the body against bacterial infections. 

According to these data, the lower dose of PledOx will give the best effect.
PledPharma has therefore applied to the regulatory authorities for reduction of
the higher dose of 10μmol/kg to 5 μmol/ kg. The reduction is primarily based on
the apparent better effect on white blood cell-related side effects with the
lower dose of PledOx. 

So far the new dose is approved in Sweden and in the U.S.

This change in dose also means that the full number (i.e. 42) randomized
patients must be included in order to be able to statistically evaluate the new
dose, which will result in an expansion of the study and an extension of the
trial period. 

Patients treated with the new dose will, however, replace the majority of
patients that should have be treated with the higher dose of 10 μmol/kg since
the dose change occurs early on in the study. 

The current estimate is that all patients should be included in the study
before the end of 2014 and that overall (top-line) data should be available
towards the end of the first quarter of 2015. 

Currently, all six patients in the dose escalation part have completed their
treatment. Furthermore, all patients being treated with FOLFOX in combination
with bevacizumab have started their treatment and DSMB has now given its
initial approval to continue the treatment with bevacizumab in combination with
FOLFOX. In addition, three patients are included in the second part of the
study (the randomized part) and at the high end of 20 centers are actively
recruiting patients to the study and these centers have identified an
additional handful of candidates to include in the study. 

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 result 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

For further information please contact:

Jacques Näsström, CEO

+46 737 13 09 79

About PledPharma

PledPharma is a Swedish pharmaceutical company that develops new therapies for
prevention of life threatening diseases related to oxidative stress. The
initial objective is to develop a drug, PledOx®, that reduces the serious side
effects associated with chemotherapy. The current market for supportive cancer
care is some USD 10 billion. PledPharma also evaluates an existing medicines
possibility to reduce the damage that occurs on the heart muscle when a patient
suffers from myocardial infarction. In addition to these projects, the company
is also evaluating opportunities of using the technology platform in other
medical areas where there is a significant unmet medical need in other
diseases. PledPharma has the potential to offer patients valuable and unique
treatments for serious life-threatening diseases where there is an opportunity
for "breakthrough therapy" designation. It also means that the company has the
potential to offer shareholders a good return on their investment. 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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