Red flag forces Cubist to halt Phase II enrollment

Cubist Pharmaceuticals slammed the brakes on enrollment for two mid-stage studies of ecallantide after the safety monitoring board noted a higher death rate among patients taking a high dose of the therapy to reduce bleeding during on-pump cardiac surgery. The move came one day after the FDA approved Dyax's ecallantide--to be marketed as Kalbitor--for hereditary angioedema. Cubist had in-licensed the drug.

The safety board raised the red flag for Cubist's CONSERV-2 trial, which is evaluating a high dose of the drug. Initial review shows mortality observed in the trial was due to a variety of causes typically expected in a high-risk-for-bleed population undergoing cardiac surgery, said the company in a statement. There was no such imbalance detected in the CONSERV-1 trial, also being monitored by the DSMB.

"When we designed Phase II to study ecallantide as therapy to reduce blood loss in on-pump cardiac surgery, we intentionally made it a robust program," said Cubist CEO Mike Bonney. "The CONSERV-2 trial in particular was intended to provide insight on all-cause outcomes in a higher risk cardiac surgery patient population. We will move as quickly as is prudent to analyze all the data from both CONSERV- 1 and CONSERV-2 in the first quarter."

- read Cubist's release
- here's the Reuters story