December 26, 2018 / 11:39 AM / 6 months ago

U.S. drug developer Capricor places Duchenne drug trial on hold

(Reuters) - Capricor Therapeutics Inc said on Wednesday it had put on hold a clinical trial of its drug to treat Duchenne muscular dystrophy (DMD), a muscle-wasting disorder, citing a safety review.

The review follows a severe allergic reaction during infusion of the drug, the company said in a filing here. The patient responded well to medical treatment and is currently asymptomatic.

The company has notified the U.S. Food and Drug Administration and is working with the agency on a mitigation plan, it said.

The trial, named “HOPE-2”, was testing the company’s lead experimental drug CAP-1002, according to California-based Capricor’s website.

DMD is a rare, genetic disorder that hampers muscle movement, mainly in men, affecting one in every 3,500 to 5,000 males. More than 90 percent of patients become wheelchair-bound by age 15.

Reporting by Manas Mishra in Bengaluru; Editing by Anil D'Silva and Shinjini Ganguli

0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below