June 4, 2013 / 1:50 PM / 6 years ago

Pluristem says FDA puts muscle pain drug study on clinical hold

June 4 (Reuters) - Pluristem Therapeutics Inc said a mid-stage trial of its experimental muscle pain drug was put on clinical hold by the U.S. Food and Drug Administration due to a serious allergic reaction in a patient.

The company, which develops therapies based on placenta-derived stem cells, said the patient required hospitalization after the reaction.

Pluristem said the study consisted of 74 patients and this was the first incident of a serious allergic reaction.

“The patient was discharged from the hospital the following day, following the resolution of all her symptoms,” the Israeli biotechnology company said.

The drug, dubbed IND 15038, aims to treat intermittent claudication or muscle pain.

Under a clinical hold, the FDA can suspend or delay an ongoing study and ask for information from the company. After submitting the data, the regulator has 30 days to respond to the applicant.

Trading was halted on the company’s stock, which was down 3.6 percent at $3.22 in premarket trading on Tuesday.

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