PledPharma receives final approval from the Ethical Committee to start clinical study

Apr 3, 2008

In December 2007 PledPharma AB received approval from the Swedish MPA (Läkemedelsverket) to conduct a phase II clinical trial at Ryhov Hospital in Jönköping.

PledPharma has now received a final approval from the Local Ethical Committee in Linköping to start the study. The study is designed to find out whether pre-treatment with the PLED-derivative PP-095 lowers the frequency and severity of side effects during adjuvant chemotherapy according to the FOLFOX6 regimen in patients operated for colon cancer in stage Dukes’ C. Professor Ursula Falkmer at the Oncology Department, Ryhov Hospital, will serve as the principal investigator in the trial.

Preclinical research has shown that PP-095 protects normal tissues without loss of antitumour activity during chemotherapy. Other advantages are that PP-095 is already approved for use in patients as a contrast agent for magnetic resonance imaging (MRI) of liver.

Assistant Professor Jan Olof G. Karlsson, responsible for R&D in PledPharma AB, says that the final approval from the Local Ethical Committee is an important step for PledPharma.

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PledPharma AB develops new pharmaceutical applications based on a clinically approved PLED-derivative, PP-095, with an initial candidate for oncology entering Clinical Phase II trials in 2008. PledPharma’s core technology is an omnipotent catalytic antioxidant that has characteristics that protect healthy cells during cancer treatment with chemotherapy and/or radiation. When used as an adjunct treatment, it has the potential to improve both clinical outcomes and patient well-being. In addition to cancer treatment, catalytic antioxidants have a wide range of potential indications, e.g., myocardial infarction, stroke and neurodegenerative diseases.