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NW Bio Provides Guidance On Phase III Trial Enrollment Timing: Completion Expected To Be Faster Or More Efficient Than Relevant Comparison Trials
Date:3/7/2013

li>Agenus, Inc. (NASDAQ: AGEN) is conducting a Phase II trial with 55 patients, which began recruiting in Q2, 2009 and stopped recruiting in Q2, 2012.

NW Bio has primarily been enrolling its Phase III trial since Q2 of 2011.  The Company undertook a limited period of enrollment in 2008, and then kept the trial going with the patients already enrolled, but suspended new enrollment due to resource constraints during the worst of the economic downturn, through the end of 2010.  The Company began the process of reactivating clinical trial sites for new enrollment in Q1 2011, and resumed screening in Q2 of 2011.

NW Bio expects to complete enrollment in its phase III trial by Q1 or early Q2 of next year – an overall enrollment period of 14 or 15 calendar quarters, including both the 2008 period and the period since Q2 2011. 

This represents a rate of enrollment that compares as follows with Celldex, IMUC and Agenus: Total Trial

 Enrollment

Enrollment

Period

Pace of Enrollment to

Completion, Based On

Enrollment Period 

NW Bio

Ph. III

 

312 patients

14 quarters or

15 quarters

22.3 patients per quarter or

20.8 patients per quarter 

IMUC

Ph. II

 

124 patients

7 quarters

17.7 patients per quarterCelldex

Ph. III

440 patients

≥16 quarters [est.]

 

27.5 patients per quarter*

 

*[164 clinical trial sites worldwide]

  

Agenus

Ph. II

 

55 patients

12 quarters

4.6 patients per quarterNotably, even if the completion of NW Bio's Phase III trial enrollment were to take substantially longer than the Company's projection of Q1 or early Q2 20
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SOURCE Northwest Biotherapeutics
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