Clinical Data, Inc announced key milestones in its two late-stage therapeutic development programmes, vilazodone and Stedivaze (apadenoson). The company reported that it has completed enrolment in the second phase-III registration trial of vilazodone for the treatment of major depression. Additionally, Clinical Data recently conducted an end of phase-II meeting with the US Food and Drug Administration (FDA) for its cardiac stress imaging agent, Stedivaze, now poised to enter phase-III studies for cardiac perfusion testing. As a result, the company is well positioned to achieve its anticipated 2009 milestones for both the vilazodone and Stedivaze phase-III clinical programmes.
"We continue to make significant progress in both of our late-stage drug development programmes and believe this reflects the knowledge, expertise and dedication of our clinical teams, as well as our ability to achieve and even exceed drug development goals," said Drew Fromkin, president and CEO of Clinical Data. "We look forward to reporting the results of our second phase-III registration trial of vilazodone in the spring of 2009 and initiating our phase-III programme for Stedivaze in the first half of calendar 2009, as planned."
Clinical Data met with the FDA, as planned, to review the results from phase-II studies of Stedivaze and to discuss the protocol for phase-III trials. Based on the meeting, Clinical Data believes that it has reached agreement with the FDA on the initial design elements for its phase-III studies.
"Our recent meeting with the FDA was very productive in providing us with important information to use in finalizing the design of our phase-III program for Stedivaze," said Carol R Reed, chief medical officer of Clinical Data. "We will continue to work with the Agency, and we remain committed to launch our phase-III programme in the first half of calendar 2009."
Clinical Data is a global biotechnology company unlocking the potential of molecular discovery, From Targeted Science to Better Healthcare.