Date: 2013-10-14
Type of information: Results
phase: 2a
Announcement: results
Company: PledPharma (Sweden)
Product: mangafodipir
Action mechanism:
Disease: patients with acute myocardial infarction undergoing percutaneous coronary intervention (PCI)
Therapeutic area: Cardiovascular diseases
Country:
Trial
details: In the MANAMI study the PLED substance mangafodipir is currently being tested in a small number of patients with acute myocardial infarction. The main purpose of the study is to show that PLED substances do not cause any obvious risk for patients undergoing PCI, and to get an indication if the PLED substances also reduces the damage to the heart - as shown in preclinical studies.
Latest
news: * On October 14, 2013, PledPharma has presented results from the MANAMI study. In this small clinical (feasibility) study recently completed at the Regional Hospital Ryhov in Jönköping, headed by chief physician and assistant professor Jan-Erik Karlsson, mangafodipir was given as an adjunct to balloon dilatation (percutaneous coronary intervention - PCI) in patients with acute myocardial infarction. Ten patients received intravenous infusion of mangafodipir and 10 patients received saline (placebo). All patients experienced their first episode of serious infarction (STEMI). They were transferred to the PCI laboratory for assessment of coronary artery occlusion and reduction of blood flow to the ischemic region. Mangafodipir or saline was given iv over 2-5 min just prior to PCI and reopening of the occluded artery.
Patients tolerated intravenous infusion of mangafodipir well without any side-effects. Magnetic resonance imaging (MRI) at ambulant control showed a tendency of smaller infarcts (26% vs. 32% for the placebo group) and improved cardiac pump function (48% vs. 42% for the placebo group) in those who received mangafodipir. This was in spite of an odd distribution between groups in disfavor of mangafodipir. Thus the mangafodipir group had a significant longer period of chest pain (206 min vs. 144 min for the placebo group) prior to PCI. The complete study results will be presented in forthcoming scientific publications.
In addition to the results in the MANAMI study, promising results have previously also been shown in the oncology study MANFOL. These studies are based on the same substance platform but in two independent diseases. "MANAMI is a small study within a very large and difficult therapeutic area. As PledPharma has previously communicated, we have chosen to focus our resources on the oncology project. However, based on these results we will now evaluate the commercial potential of the myocardial infarction indication”, says CEO Jacques Näsström.
* On April 18, 2013, PledPharma has announced that the MANAMI study is fully recruited. All patients were included in this current small investigator initiated clinical phase IIa trial, which examines a PLED substance in patients with acute myocardial infarction undergoing percutaneous coronary intervention (PCI). Results of the study are expected during 2013. Preclinical studies show that PLED substances reduce permanent damage to the heart that often arises in the context of an acute myocardial infarction. Preclinical data also indicate that the use of PLED drugs in severe heart disease should not pose any safety risk.
