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PledPharma receives advice from the FDA for the continued development of PledOx®

May 2, 2017

PledPharma AB
Company Announcement

PledPharma receives advice from the FDA for the continued development of PledOx®

Stockholm, 2017-05-02 08:00 CEST (GLOBE NEWSWIRE) -- 

At PledPharma's Annual General Meeting on April 25, the company presented
information that the PledOx® project is in an intense phase, which includes
discussions with regulatory authorities to define the continued development

Today, PledPharma informs about the advice provided by the FDA on April 29,
based on a meeting held on March 30, 2017. This advice provides important
strategic information for the continued development of PledOx® from an US

Together with the FDA, PledPharma has agreed that the next important study for
PledOx® future registration procedure aims to verify the selected primary
endpoint, patient-reported outcome measurement for oxaliplatin-induced
peripheral neuropathy, as well as a longer follow-up period. This will be
performed in a study on patients with incurable metastatic colorectal cancer. 

This study design is well in line with the requirements brought forward by
potential future partners for PledOx®. The FDA wishes to review these data
before a study of adjuvant treatment of colorectal cancer can be conducted in
the United States. This is a discrepancy to the advice previously obtained from
the European Medicines Agency, EMA, that advocated a study in the adjuvant
setting. The final development plan for PledOx® will therefore be decided after
a follow-up with EMA. 

The meeting with the FDA was productive and defined a clear path going forward
for PledOx®, also in the US market. Existing funding from the rights issue in
November is expected to enable the continued development of PledOx® as well as
the recently announced Aladote® study, says Jacques Näsström, CEO PledPharma. 

For further information, please contact:

Jacques Näsström, Chief Executive Officer

Tel. +46 (0)73-713 09 79

About PledPharma

PledPharma develops new drugs that protect the body against oxidative stress –
a potentially debilitating and sometimes life-threatening condition that can be
caused by chemotherapy treatment and following acetaminophen (paracetamol)
overdose. The company's most advanced project PledOx® is being developed to
reduce nerve damage associated with chemotherapy. A phase IIb study has been
conducted and will serve as the basis for the continued development. The drug
candidate Aladote® is being developed to reduce the risk of acute liver failure
associated with acetaminophen poisoning. 

PledPharma (STO: PLED) is listed on Nasdaq First North. Erik Penser Bank is the
company’s Certified Adviser (tel +46 8 463 80 00). For more information, see 

This information is information that PledPharma AB (publ) is obliged to make
public pursuant to the EU Market Abuse Regulation. The information was
submitted for publication, through the agency of the contact person set out
above, at CET 08:00 on May 2, 2017.



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