News | News By Subject | News by Disease News By Date | Search News
Get Our FREE
Industry eNewsletter
email:    
   

Mirna Reports Third Quarter 2016 Financial Results And MRX34 Clinical Program Updates



11/11/2016 1:22:46 PM

  Life Sciences Jobs  
  • Newest Jobs - Last 24 Hours
  • California Jobs
  • Massachusetts Jobs
  • New Jersey Jobs
  • Maryland Jobs
  • Washington Jobs
  View More Jobs

AUSTIN, Texas--(BUSINESS WIRE)--Mirna Therapeutics, Inc. (Nasdaq: MIRN), a biopharmaceutical company focused on microRNA-based oncology therapeutics, today reported financial results for the third quarter of 2016 and provided an update on recent developments.

“We were disappointed with the outcome of our Phase 1 study, however, our first priority in developing innovative therapeutics is the safety of patients”

MRX34 CLINICAL PROGRAM

In September 2016, the Company voluntarily halted the ongoing Phase 1 trial of its first product candidate, MRX34, following multiple immune-related serious adverse events (SAEs) observed in patients dosed with MRX34 over the course of the trial. Three of these immune-related events resulted in the patient’s death. Subsequently, the U.S. Food and Drug Administration (FDA) notified the Company that the Investigational New Drug (IND) Application for MRX34 has been placed on full clinical hold. Among other comments, the FDA requested a final clinical study report be submitted and noted that a risk-benefit summary with sufficient justification for the continued development of MRX34 would be necessary if the Company requested removal of the clinical hold.


Read at BioSpace.com


comments powered by Disqus
   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES