Hayward, CA-based Anthera Pharmaceuticals ($ANTH) announced this morning that it is suspending dosing and enrollment in a Phase IIb study of its experimental lupus drug after a clinical investigator discovered that some of the vials containing the drug were cracked. A visit to the drug store room led researchers to conclude that the cracking was "not an isolated problem."
"The safety of our patients and the trust of the healthcare professionals involved in our clinical trials are of the utmost importance to Anthera so we have voluntarily placed PEARL-SC on hold until we can satisfactorily address the vial cracking that has been reported," said Paul Truex, CEO of Anthera Pharmaceuticals. "Getting to the root of this issue and resuming the clinical program for A-623 is a top priority. We believe that A-623 represents a promising therapeutic option for patients with autoimmune diseases and remain committed to working as quickly as possible to resolve this issue and discuss our plans with the FDA. We intend to provide a further update once those plans are in place."
As Xconomy reports this morning, Anthera has had its ups and downs over its five-year history. This week was intended to end on a high note as Truex and other company officials journeyed to the AHA meeting in Chicago to make their case for the potential of the developer's lead drug, A002, which is designed to prevent heart attacks and strokes by tamping down on excess inflammation.
Anthera is at the AHA meeting to tout plans for a pivotal trial of A002--their lead drug licensed from Eli Lilly and Shionogi--which will need up to 6,500 patients to provide the data it needs for an approval.
- see the Anthera release
- read the Xconomy story on Anthera