Phase III clinical trial with 4-month long-acting formulation of triptorelin: Ipsen decides not to perform further administration
- Category: Proteins and Peptides
- Published on Tuesday, 12 June 2007 04:00
- Hits: 1759
PARIS, France | June 11, 2007 | Ipsen (Euronext: FR0010259150; IPN) announced today that the preliminary data from the ongoing phase III study for its investigational 4-month formulation of triptorelin do not support the expected sustainable blood levels of triptorelin for a duration of 4 months in all patients. Therefore, Ipsen has decided not to perform the second administration as planned in the protocol. No safety concerns have been observed throughout the trial. At the end of their respective monitoring period, patients will be switched to appropriate approved treatment.
The 4-month investigational product, one of Ipsen’s new sustained release formulation candidates of triptorelin using one amongst several Ipsen proprietary technologies, has shown an adequate efficacy and safety profile in phase II allowing a move to phase III. Ipsen’s goal remains to have a new formulation of triptorelin available when the current patents of the 3-month formulation of Decapeptyl® expire.
Jacques-Pierre Moreau, Executive Vice-President, Chief Scientific Officer of Ipsen said: “We are taking all appropriate actions to solve the scale-up issues seen during this phase III, which are inherent to advanced formulations based on cutting edge technologies. From the onset, the introduction of an innovative subcutaneous presentation using a new retro-injection device was well received by patients and investigators. Thus, the teams are now focusing their energy and expertise in order to resume phase III as soon as possible. Our advanced drug delivery platform has already been validated through the success of Somatuline® Autogel®, and we are confident in Ipsen’s ability to have a differentiated formulation of triptorelin.”