Guilford Pharmaceuticals Restarts Aquavan Clinical Development Program

Guilford Pharmaceuticals has met with the FDA and reached an agreement on a revised clinical development strategy for the company's lead product candidate, Aquavan injection (GPI 15715), a novel sedative/hypnotic being developed for use in procedural sedation.

Under the revised strategy, Guilford will immediately reinitiate its previously planned studies for ICU sedation and potential drug interactions. The design of the dose-ranging trial in colonoscopy is being finalized in consultation with the FDA.

Based on the findings of this study, Guilford expects to commence two pivotal trials, one in colonoscopy and the other in minor surgical procedures. Guilford continues to expect to file its new drug application for Aquavan during the second half of 2006.