PledPharma receives approval to conduct a clinical phase II study in patients with Acute Myocardial InfarctionAug 13, 2009
PledPharma AB has received approval from the Swedish Medical Products Agency (MPA; Läkemedelsverket) to start a clinical phase II study in patients with Acute Myocardial Infarction.
The trial will be conducted at the County Hospital Ryhov in Jönköping, Sweden, and Dr JanErik Karlsson at the Department of Internal Medicine, will serve as the principal investigator in the trial.
Active reopening of occluded coronary arteries by primary percutaneous coronary intervention (PCI) has led to reduction in infarct size, but there is still a need for improvement.
The aim of the present study is to test whether PP-099, a LowMEM (Low Molecular weight Enzyme Mimetic), further reduces myocardial infarct size in patients undergoing primary PCI. Preclinical studies indicate that PP-099 may reduce myocardial infarct size by more than 50 %.
“I am pleased by the decision of the Swedish MPA”, says Professor Per Jynge, Medical Director in PledPharma AB. “The study might lead to a more effective reduction in infarct size during treatment with PCI, and thereby decrease the incidence and severity of secondary heart failure after Acute Myocardial Infarction.
The principal investigator has to wait for approval from the Local Ethical Committee before the first patient can be enrolled in the study. The decision from the Local Ethical Committee is expected to come within a couple of weeks.
Over the last 30 years mortality in Acute Myocardial Infraction has been reduced from 25% to less than 10%, but due to remaining myocardial injury the number of surviving patients that develop chronic heart failure is rising. It is hence an unmet medical need to find treatments that can further reduce the myocardial injury.
For further information, please contact:
Per Jynge, Medical Director, PledPharma AB, +47 735 115 55
PledPharma AB develops new medicines based on Low Molecular weight Enzyme Mimetics (LowMEM) with an initial candidate PP-095 for oncology. PP-095 protects against dose-limiting side effects during cancer therapy with cytostatic drugs, without diminishing the anticancer effect. PP-095 entered clinical phase II trials in cancer patients in 2008. In addition to cancer treatment, LowMEMs have a wide range of potential indications, e.g., myocardial infarction, stroke and neurodegenerative diseases.
For more information see www.pledpharma.se