Tuesday, May 12, 2009 8:18:15 AM
http://seekingalpha.com/article/137082-fda-clinical-trial-calendar-updates-astrazeneca-announces-phase-iii-results?source=yahoo
ImmunoGen (NASDAQ:IMGN)
T-DM1: This TAP compound comprises ImmunoGen's DM1 cell-killing agent linked to the HER2-binding antibody, trastuzumab. It is in development by Roche (RHHBY.PK) through its acquisition of Genentech. Patient enrollment was completed in March 2009 in the Phase 2 trial evaluating T-DM1 as a third-line treatment for HER2-positive metastatic breast cancer. Enrollment in this 100-patient, multi-center study began in July 2008. Genentech expects final study data by 1Q10 and has stated that, if the data from this study are compelling, it will discuss an earlier approval path with the FDA.
Final results from the 100-patient "second-line plus" Phase II trial for T-DM1 will be reported at the upcoming ASCO annual meeting. Patient enrollment in this trial began in mid-2007 and was completed by mid-2008. ASCO is the American Society of Clinical Oncology Annual Meeting being held May 29 - June 2, 2009.
IMGN901: This ImmunoGen TAP compound is in clinical testing for the treatment of CD56-positive multiple myeloma (Study 003) and solid tumors (Study 002). Both Studies 003 and 002 are Phase 1 dose-escalation trials, with IMGN901 given as a single agent to patients whose cancer has progressed on the approved treatments for their disease. Dose escalation has completed in Study 003, a key step to establishing the maximum tolerated dose (MTD).
This study includes an expansion phase in which additional patients will receive IMGN901 at the MTD. Data from Study 003 are expected to be reported at a clinical conference during 4Q09. Dose escalation is ongoing in Study 002, with data presentation expected during 4Q09.
IMGN242: This ImmunoGen anticancer compound is in Phase 2 testing for the treatment of CanAg-expressing gastric cancer that failed first-line treatment. Early data from this trial will be reported in an abstract at the ASCO annual meeting and IMGN expects to determine in 2009 whether this study will be expanded or concluded.
ImmunoGen (NASDAQ:IMGN)
T-DM1: This TAP compound comprises ImmunoGen's DM1 cell-killing agent linked to the HER2-binding antibody, trastuzumab. It is in development by Roche (RHHBY.PK) through its acquisition of Genentech. Patient enrollment was completed in March 2009 in the Phase 2 trial evaluating T-DM1 as a third-line treatment for HER2-positive metastatic breast cancer. Enrollment in this 100-patient, multi-center study began in July 2008. Genentech expects final study data by 1Q10 and has stated that, if the data from this study are compelling, it will discuss an earlier approval path with the FDA.
Final results from the 100-patient "second-line plus" Phase II trial for T-DM1 will be reported at the upcoming ASCO annual meeting. Patient enrollment in this trial began in mid-2007 and was completed by mid-2008. ASCO is the American Society of Clinical Oncology Annual Meeting being held May 29 - June 2, 2009.
IMGN901: This ImmunoGen TAP compound is in clinical testing for the treatment of CD56-positive multiple myeloma (Study 003) and solid tumors (Study 002). Both Studies 003 and 002 are Phase 1 dose-escalation trials, with IMGN901 given as a single agent to patients whose cancer has progressed on the approved treatments for their disease. Dose escalation has completed in Study 003, a key step to establishing the maximum tolerated dose (MTD).
This study includes an expansion phase in which additional patients will receive IMGN901 at the MTD. Data from Study 003 are expected to be reported at a clinical conference during 4Q09. Dose escalation is ongoing in Study 002, with data presentation expected during 4Q09.
IMGN242: This ImmunoGen anticancer compound is in Phase 2 testing for the treatment of CanAg-expressing gastric cancer that failed first-line treatment. Early data from this trial will be reported in an abstract at the ASCO annual meeting and IMGN expects to determine in 2009 whether this study will be expanded or concluded.

