FDA Puts Aduro Trial on Clinical Hold after Positive Listeria Tests

Oct 26, 2016

Street Insider

Aduro Biotech has received notice from the FDA that trials with investigational agents based on its LADD (Listeria-based immunotherapy construct) platform have been placed on partial clinical hold to pause new patient enrollment.

The Aduro trials are testing engineered immunotherapy platforms, based on live, attenuated, double-deleted Listeria monocytogenes.

The partial hold was initiated following notification to the FDA that a blood culture sample from an indwelling port of a metastatic pancreatic cancer patient who presented with gastrointestinal symptoms tested positive for Listeria, which is suspected to be CRS-207.

The California-based biotech is working with the FDA to lift the partial hold so as to resume new patient enrollment in its trials.

Read the Street Insider coverage

Show Comments
Hide Comments

Join the discussion

We welcome your thoughtful comments.
All comments will display your user name.

Want to participate in the discussion?

Register for free

Log in for complete access.

Comments

No one has commented on this page yet.

RSS feed for comments on this page | RSS feed for all comments