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Pledpharma utvecklar en ny behandling av hjärtinfarkt och var under 2010 i full färd med att rekrytera patienter till sin kliniska fas IIa-studie då Läkemedelsverket satte stopp. Anledningen var att tillverkaren av läkemedelskandidaten, GE Healthcare, hade upphört med tillverkningen.
Pledpharma hade inlicencierat rätten att testa företagets kontrastmedel Teslascan i klinik då medlet visat sig förebygga återflödesskador som uppstår vid bollongvidgningsbehandlingar i samband med hjärtinfarkter. Efter det har kontraktstillverkningsbolaget Recipharm på uppdrag av Pledpharma börjat tillverka en motsvarande produkt, mangafodipir. Som ny produkt på marknaden fick mangafodipir genomgå läkemedelsverkets godkännandeprocess och har nu fått godkänt.
I samband med detta sätts Pledpharmas studie därför i rullning igen. I studien ingår totalt 20 patienter, varav tio kommer att behandlas med Pledpharmas substans och resterande får placebo. Effekten kommer att mätas med hjälp av enzymer och analyseras med magnetkamera. Hittills har åtta patienter rekryterats.
Pledpharma utvecklar läkemedel utifrån substansklassen Pled-derivat, substanser som skyddar kroppens celler mot oxidativ stress. Till sommaren planerar Pledpharma att starta en fas IIb-studie med samma upplägg som den aktuella, fast denna gången med en substans som utvecklats ur Pled-plattformen.
Pledpharma hade inlicencierat rätten att testa företagets kontrastmedel Teslascan i klinik då medlet visat sig förebygga återflödesskador som uppstår vid bollongvidgningsbehandlingar i samband med hjärtinfarkter. Efter det har kontraktstillverkningsbolaget Recipharm på uppdrag av Pledpharma börjat tillverka en motsvarande produkt, mangafodipir. Som ny produkt på marknaden fick mangafodipir genomgå läkemedelsverkets godkännandeprocess och har nu fått godkänt.
I samband med detta sätts Pledpharmas studie därför i rullning igen. I studien ingår totalt 20 patienter, varav tio kommer att behandlas med Pledpharmas substans och resterande får placebo. Effekten kommer att mätas med hjälp av enzymer och analyseras med magnetkamera. Hittills har åtta patienter rekryterats.
Pledpharma utvecklar läkemedel utifrån substansklassen Pled-derivat, substanser som skyddar kroppens celler mot oxidativ stress. Till sommaren planerar Pledpharma att starta en fas IIb-studie med samma upplägg som den aktuella, fast denna gången med en substans som utvecklats ur Pled-plattformen.
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