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"The phase II clinical trial is a major milestone for Action Pharma andwe are very impressed with the efficient and professional team atRigshospitalet headed by chief consultant, professor Daniel Steinbruchel asprincipal investigator", says S0ren Nielsen, MD, DMSci, CEO of Action Pharma"Many patients in the USA and Europe undergo major thoracic surgery everyyear, and approximately 10-20% of these patients experience various degreesof kidney injury which again is associated with increased mortality,co-morbidity and prolonged hospitalization. Thus, in this indication there isa major unmet medical need."
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The clinical trial investigating AP214 in cardiac surgery is conducted atRigshospitalet, Department of Cardiac and Thoracic Surgery is a randomized,double-blind placebo-controlled dose-finding phase II trial in patientsundergoing cardiac surgery. A total of 42 patients will be enrolled in thetrial. Dosing of the first patient was initiated in June 2009 and dosing ofthe first cohort was completed in August 2009.
"AP214 is a new first in class drug candidate with novel mode of actionand mediates its action through new pharmacological targets, the melanocortinreceptors. AP214 is expected to reduce the inflammatory response as well aspost-surgical reperfusion injuries, factors known to cause kidney injury,"says Thomas Jonassen, MD, CSO of Action Pharma. "We have completed part of aphase II study conducted in the US at Shands Hospital in Gainesville, Floridaand a phase Ib clinical trial at AKH in Vienna investigating the effect ofAP214 in the setting of experimentally induced inflammation in humanvolunteers with positive results. Based on these studies and preclinicalstudies we conclude that AP214 is safe and well tolerated and is a verypotent drug candidate to treat or prevent organ injury," adds Dr Jonassen.
The Action Pharma team has significant scientific expertise in the areasof cardiovascular pharmacology, kidney function and kidney diseases with morethan 250 published scientific papers within these areas. Action Pharma isdedicated to the discovery, research and development of novel drugs targetingmelanocortin receptors. In addition to prevention of kidney injury,stimulation of melanocortin receptors has shown promise as a treatment fortype 2 diabetes, obesity and inflammatory diseases. The current pipeline of 4compounds in development provides outstanding business development potentials.
About Action Pharma A/S
Action Pharma is a privately owned Danish biotech company. The mainstrategy of Action Pharma is to develop novel drug candidates targetingmelanocortin receptors and bring these to clinical proof of concept forsubsequent partnering. The drug candidates are first in class and exploitnovel mode of action profiles with efficacy that is superior compared to thecurrent market. Action Pharma has a pipeline of several patent protected drugcandidates of which two currently are in clinical development and two in latepreclinical development.
AP1030, the lead compound within the company's small molecule program,has potent pre-clinically documented anti-diabetic and anti-obesity effects.AP1030 is currently in clinical development in obese individuals in a twoweek clinical trial. AP1030 has the potential to be superior to otheranti-diabetics including GLP-1 analogues, DPP-4 inhibitors and glitazones.AP1030 can be administered orally in contrast to GLP-1 analogues. The markedweight reducing effects observed in non-clinical pharmacodynamic modelscontrast the absence of weight reduction by other orally availableantidiabetics (DPP-4 inhibitors and others). Thus, this makes AP1030 highlyattractive in the market for Type II diabetes associated with obesity. Themode of action of AP1030, first in class, involves a central melanocortintype 4 receptor mediated effect, thereby modulating appetite and centralregulation of glucose metabolism plus a systemic anti-inflammatorymelanocortin type 1 receptor mediated anti-diabetic effect aimed at revertinglow grade inflammation in fatty tissue and thereby reducing peripheralinsulin resistance.
Action Pharma is developing AP214 to prevent post-surgical kidney injuryafter major thoracic surgery. AP214 is currently being tested in a phase IIclinical trial in the USA and Denmark investigating the effect of AP214 onorgan protection in patients undergoing cardiac surgery, who are at increasedrisk of kidney injury. More than 150,000 patients in the USA and EU undergomajor thoracic surgery every year. Approximately 10-20% of these patientsexperience various degrees of kidney injury which again is associated withincreased mortality, morbidity and prolonged hospitalization. AP214 mediatesits potent effect via the type 1 and type 3 melanocortin receptors. Initialresults from an earlier phase II clinical trial in the US and from a phase IBtral in human volunteers subjected to LPS-induced inflammation revealedpositive effects of AP214.
In addition, Action Pharma develops AP1189 which is targeted for oraladministration for treatment of systemic inflammatory diseases such asrheumatoid arthritis and inflammatory bowel diseases. Similarly, AP405 isdeveloped for topical treatment of inflammatory skin diseases, such as atopicdermatitis.
Action Pharma has a strong investor base of leading European investorsincluding Sunstone Capital, Global Life Science Ventures, InnovationsKapital,SLS Venture, Inventure Capital, and Oestjysk Innovation. For moreinformation, please visit http://www.actionpharma.comFor further information, please contact: Soren Nielsen CEO, Action Pharma A/S Dronninggaards Alle 136 DK-2840 Holte, Denmark [email protected] Phone: +45-23244533
SOURCE Action Pharma
