Theratechnologies to continue phase 3 TH9507 trial

By Elaine Rigoli

Tampa, Fla., July 6 - Theratechnologies said an independent Data and Safety Monitoring Board has recommended that its phase 3 clinical study on TH9507 for the treatment of HIV-associated lipodystrophy be continued as currently being conducted.

The monitoring board is comprised of independent medical experts and is responsible for monitoring the safety aspects of the phase 3 clinical study.

"The [Data and Safety Monitoring Board's] favorable recommendation reinforces our confidence in the safety profile of TH9507. This profile will be an important asset in our commercialization strategy," president and chief executive officer Yves Rosconi said in a news release.

"With 280 patients having now completed 13 weeks of treatment, the trial continues to progress on schedule and we expect the first phase 3 study results around the end of this year," he said in the release.

The recommendation made by the board is based on a recent review of the safety data on 181 patients who have been treated for three months. After reviewing the safety data, the board concluded that the trial should continue as per protocol.

Theratechnologies is a biopharmaceutical company located in Montreal.

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