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Marvel Clinical Research

A Brief Guide to Marvel Clinical Research

During the last several years, marvel clinical research has been able to produce a great deal of useful and interesting information about diseases. This information includes things such as the way diseases develop, how to cure them and what treatments they can use. In fact, the information that has been gathered has helped thousands of people to find out how they can improve their health.

Overview

Listed below is a quick and dirty overview of Marvel clinical research. Hopefully this brief guide provides you with the knowledge to make your own unbiased decision. Marvel is a biotechnology company with a knack for the baffling, and has been known to go overboard on the research and development side. Some of their more exciting programs include the MB-204, a new class of drug that targets the blood brain barrier. The company also has a novel fluorinated form of istradefylline, an FDA approved anti-Parkinson’s disease drug. The company’s research and development team is also hard at work on a new portfolio of drugs.

Results

During the Heart Failure Society of America’s annual meeting held in Boston, Mass., Dr. Thomas Povsic, Assistant Professor of Medicine at Duke University, presented the final results of the MARVEL clinical trial. The trial was conducted in order to find out whether or not the MB-204 cell therapy would be effective in patients suffering from Fabry disease. The cell therapy is believed to treat the disease’s underlying cause, which is the buildup of fat in the cells. The disease is a debilitating inherited disorder that can lead to progressive organ damage and early death.

During the MARVEL trial, patients were given 16 injections of the cell therapy, which is administered directly into the weakened ventricular wall. In most cases, the arrhythmias disappeared completely by six months after treatment. The results are promising, and investigators believe that early detection and management strategies could help reduce the risk of recurrent arrhythmias. In addition, the results of the trial show that the MB-204 cell therapy has low toxicity, which provides the company with confidence to continue its efforts to get the drug approved by the FDA.

Conclusions

MARVEL clinical research is designed to evaluate the safety and effectiveness of an image-guided catheter-based intramyocardial injection of myoblasts in patients with class II-IV heart failure. The study is conducted in accordance with the Declaration of Helsinki and Good Clinical Practice principles. All patients were enrolled in the trial and received informed consent. The study was registered under NCT03330002. MARVEL was approved by the Institutional Review Boards.

The primary safety objective was to demonstrate that the automated enhanced accelerometer-based algorithm did not result in an increase in the number of beats per hour. Secondary objectives included the following: to show that the algorithm was safe for patients with class II-IV HF; to show that the algorithm was safe for patients who had undergone the procedure for the first time; to demonstrate that the algorithm was effective in the treatment of heart failure; and to show that the algorithm could be safely administered.

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