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Re: rfj1862 post# 40092

Tuesday, 01/02/2007 4:18:11 PM

Tuesday, January 02, 2007 4:18:11 PM

Post# of 253597
Re other pipeline RPRX competitors
I'm trying to get the latest on the other SPRM trials to see if they ran into longer term problems that might signal caution to us as investors in RPRX.

I can find nothing later than this on the phase III mifepristone leiomyoma trial.
http://clinicaltrials.gov/ct/show/NCT00133705

Here is a clip that effectively ended the asprisnil P3 trial by Schering/TAP.

"Schering AG and TAP announce extension studies with investigational compound asoprisnil will be amended
Schering
October 12, 2005
Berlin, October 12, 2005

Schering AG, Germany (FSE: SCH, NYSE: SHR) and TAP Pharmaceutical Products Inc. announced today that extension studies performed with asoprisnil, an investigational compound for the management of symptomatic uterine fibroids, will be amended. Asoprisnil is being investigated for its ability to reduce uterine bleeding, shrink the fibroids, as well as reduce pressure symptoms.

Following Phase III controlled trials, patients were able to elect to participate in extension studies which would have extended their total therapy duration for up to four years. During the clinical study program, some patients experienced endometrial changes, which were reversible in most patients after stopping therapy and resulted in additional invasive procedures. In view of these findings, the extension studies will be amended and dosing will be discontinued. Investigators will continue to follow-up with patients as part of the ongoing extension studies.

"Based on Phase II and Phase III data, we believe that asoprisnil may be a promising therapy for the millions of women who suffer from uterine fibroids whose current options remain invasive procedures," said Phil Smits, M.D., Head of Global Business Unit Gynecology&Andrology, Schering AG.

Both companies will continue to discuss submission plans with the U.S. and European regulatory authorities.

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