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 plan. 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 perspective. 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 firstname.lastname@example.org 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 www.pledpharma.se 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.