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FDA has approved IND application for clinical trial with PledOx in the U.S.

January 21, 2013

PledPharma AB
Company Announcement

FDA has approved IND application for clinical trial with PledOx in the U.S.

Stockholm, 2013-01-21 08:30 CET (GLOBE NEWSWIRE) -- PledPharma (STO: PLED)
announced today that their PledOx™ Phase IIb clinical trial, PLIANT, is
approved by the U.S. Food and Drug Administration (FDA). The goal of the PLIANT
study is that pretreatment with PledOx reduces serious side effects of the
chemotherapy FOLFOX in patients treated for advanced colorectal cancer. 

Patients will be randomized to receive two different doses PledOx, the compound
developed by PledPharma, or placebo. The estimated number of patients included
in the randomized phase of the study is 126 (42 in each of the 3 groups). The
study is planned to be carried out in several centers in Europe and the U.S.
For further details see 

"We are very pleased with the positive assessment by the FDA. Since the U.S. is
perhaps the single most important market, it is particularly encouraging that
we received approval for our study there. In addition, an Investigational New
Drug (IND) approval by the FDA is a sign of quality and something that is seen
as positive by both other agencies and businesses, "says CEO Jacques Näsström. 

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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Address: Klara Norra Kyrkogata 26, SE 111 22 Stockholm, Sweden

Phone: +46 8 679 72 10