Date: 2014-11-21
Type of information: Results
phase: 2
Announcement: results
Company: Proteo (USA - NV) Proteo Biotech (Germany)
Product: elafin
Action
mechanism: Elafin is a copy of a naturally occurring human anti-inflammatory substance. It is a natural antagonist of the tissue destroying enzymes (proteases) that participate in the inflammatory mechanism of many diseases. Elafin’s ability to block the enzymes that cause these undesirable effects makes it a promising drug for the treatment of e.g. inflammatory lung diseases and severe reperfusion injury. The tolerability of intravenously administered recombinant Elafin has already been demonstrated convincingly in a Phase I clinical trial. The outcome of a Phase II clinical trial on the treatment of postoperative inflammatory reactions in esophagus carcinoma show that intravenously administered Elafin has a clear positive effect on the period of recovery: 63 percent of the Elafin treated patients required only one day of intensive care. All patients in the placebo group needed several days of postoperative intensive medical care. The Company has already received scientific advice for orphan medicines from the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) for conducting a pivotal clinical trial with Elafin for the prophylactic treatment of acute postoperative complications after resection of esophageal cancer (“POSTCOM TRIAL”).
Disease: prevention of myocardial injury after coronary artery bypass surgery
Therapeutic area: Cardiovascular diseases
Country:
Trial details:
Latest
news: * On November 21, 2014, Proteo and its wholly-owned subsidiary Proteo Biotech announced that the NHS Lothian’s Edinburgh Heart Centre has completed final analysis of data from the investigator initiated Phase II clinical trial (EMPIRE study) with Proteo’s drug candidate Elafin for prevention of myocardial injury after coronary artery bypass surgery (CABG). The EMPIRE study was designed as a randomized, double-blinded and placebo-controlled study on 87 patients to investigate the therapeutic potential of a single preoperative Elafin dose on postoperative myocardial injury. This was measured by troponin I plasma concentration which is released by damaged heart muscle cells and its plasma concentration correlates with overall damage of the heart muscle. It was assumed that this treatment would lower the troponin I release over 48 hours. Publication of the EMPIRE study results is planned in a peer reviewed journal. The study confirmed the favorable safety profile of Elafin. No drug related adverse events and no evidence of excessive bleeding, cardiovascular complications or renal dysfunction was reported in this critical patient population. Statistically significant reduction of the area under the curve for plasma troponin I concentration profile over the first 48 h could not be shown in this trial. Post-hoc analysis identified significantly reduced troponin I plasma concentrations by 41% within the first 6 hours after Elafin treatment. \"An unexpected skewed distribution of troponin I plasma concentrations in the patient groups was observed in the study and consequently the study turned out to be underpowered,\" said principal investigator cardiologist Dr. Peter Henriksen at NHS Lothian\'s Edinburgh Heart Centre. \"This contradicts observations from an earlier UK study in CABG surgery patients which was taken as a reference for the study design and sample size calculation. This study provides sufficient information for design of an adequately powered follow up study with an indication that multiple doses in the postoperative period may be more effective.\" Professor Oliver Wiedow, Director of Proteo, Inc., said: \"I would like to thank the investigators and their co-workers for this proof of concept study initiative. Results from this study contribute to our understanding of the therapeutic potential of Elafin and the time course of reperfusion injury in CABG. The results confirm the favorable safety profile of Elafin and additionally there are indications that Elafin has a beneficial effect on the protection of heart muscle tissue as long as Elafin is present in the blood.\"
