PledPharma has, in collaboration with the Oncology Clinic at Ryhov County Hospital in Jönköping, conducted a small randomized clinical trial on patients who have had surgery for colorectal cancer and then received chemotherapy.
No serious side effects of the chemotherapy were observed in the patients who received PP-095 (mangafodipir), while several serious side effects (grades 3 and 4 on the 4-point NCI-CTCAE scale) were observed in the patients who received placebo. The difference between the groups is statistically significant.
”Today, serious side effects of chemotherapy treatment are a major problem for patients with colorectal cancer”, says Professor Ursula Falkmer who is in charge of the study. She also says that we now have effective antineoplastic agents for use in the treatment of colorectal cancer but points out that their side effects render their use more difficult. It is therefore desirable that forms of treatment are found that can reduce the side effects and thereby render the chemotherapy more effective.
”This is the first time that we test on patients to establish whether mangafodipir reduces the side effects. Consequently, the study comprises relatively few patients, however the results are unquestionably interesting” Professor Falkmer continues. ”We therefore look forward with great anticipation to continuing with the clinical trials”.
The study was designed to establish whether pre-treatment with the PLED-derivative PP-095 reduces serious FOLFOX6-induced adverse events during adjuvant chemotherapy according to the FOLFOX6 regimen in patients operated for colorectal cancer stage Dukes’ C. Fourteen patients were randomized to receive either pre-treatment with placebo or mangafodipir during 3 FOLFOX6 cycles.
For further information, please contact Jan Olof Karlsson at +46 733 304 624
PledPharma AB develops new pharmaceutical applications based on a clinically approved PLEDderivative with an initial candidate for oncology. PledPharma’s core technology is an omnipotent low molecular weight enzyme mimetic (lowMEM) with SOD mimetic activity that has characteristics to 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, SOD mimetics have a wide range of potential indications, e.g., myocardial infarction, stroke and neurodegenerative diseases.
For more information, please visit www.pledpharma.se