Immunotherapy Firm Gets Green Light for Pivotal Trial From FDA
Research Report


Jason Kolbert, an analyst with Maxim Group, described the study, which enables this biotech's device to be used in patients undergoing heart surgery and will measure its effectiveness in reducing a common post-surgical side effect.

A Dec. 21 Maxim Group research report indicated the FDA has approved CytoSorbents Corp.'s (CTSO:NASDAQ) investigational device exemption application (IDE) to conduct its REFRESH 2 trial. This milestone represents "a critical point for the company," noted analyst Jason Kolbert. "The trial by its nature (IDE) is 'pivotal,' designed to support the use of CytoSorb in cardiac surgery."

Kolbert explained that during surgery, CytoSorb can "capture and broadly reduce different kinds of cytokines and other inflammatory mediators that drive inflammation."

Now having a green light, REFRESH 2 in the United States should start soon, wrote Kolbert. Randomized, controlled and involving multiple centers, the trial aims to determine the effectiveness of CytoSorb blood treatment in reducing acute kidney injury following cardiac surgery, a common adverse side effect.

The study will encompass up to 400 patients who are slated to have "elective, nonemergent, open heart surgery for either valve replacement or aortic reconstruction with hypothermic cardiac arrest," Kolbert reported. All patients, control and treatment, will receive standard of care during surgery. Treatment patients, however, will also receive CytoSorb blood treatment intraoperatively.

Other potential endpoints to be investigated in REFRESH 2 include "time on mechanical ventilation, the use of vasopressors or other hemodynamic support, days in the intensive care unit, reduction in inflammatory mediators and mortality at 30 days," the analyst indicated.

Kolbert also recapped the findings from REFRESH 1, which evaluated the effectiveness of CytoSorb in treating inflammation in both cardiac surgery and critically ill patients. The study showed, with the use of CytoSorb, a statistically significant reduction, 26%, in plasma-free hemoglobin levels at three and a half hours. Levels were an additional 38% lower at four hours.

Maxim Group has a Buy rating and a $12 per share 12-month target price on CytoSorbents Corp., whose stock is currently trading at around $6.65 per share.

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