PAION initiates Phase II trial with its anesthetic/sedative CNS 7056
- Program moved from pre-clinical to Phase II in 10 months
- Completion expected by year end 2009
Aachen (Germany), 15 April 2009 – The biopharmaceutical company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange, Prime Standard: PA8) today announces the commencement of the initial Phase II study with CNS 7056, a new short-acting intravenous anesthetic/sedative. The study will enroll 100 patients undergoing diagnostic endoscopy of the upper gastrointestinal tract. The Phase II trial is a randomized, double blind study examining three doses of CNS 7056 compared with midazolam in one hundred patients undergoing a diagnostic endoscopy of the upper gastrointestinal tract. The study is being conducted in multiple sites in the U.S. It is designed to evaluate the safety of CNS 7056 and the success of the sedation, as well as the time to full recovery and discharge, in comparison to the 'gold-standard' agent, midazolam. The study is expected to complete before the end of 2009. A successful proof-of-concept Phase I study of CNS 7056 reported results in January of this year. "The rapid progression from a pre-clinical program to a Phase II trial in 10 months is the result of our focused development approach," commented Wolfgang Söhngen, CEO of PAION. "We at PAION are focused on turning CNS 7056 into a key value driver. We are hopeful that the current study will confirm that CNS 7056 is a valuable alternative for procedural sedation. The growing number of out-patient interventions requires a rapid recovery while avoiding the potential for prolonged or overly deep sedation. A product of this profile has the potential to improve patient well-being and reduce cost through reducing resources needed for supervision."
Published: 15th Apr 2009 - 08:37:10
Modified: 15th Apr 2009 - 08:38:31