Telecon #2, November 9, 2009 - Laviv

• 11/4/2009       11am-Noon                         
• RE:       Isolagen Clinical Tissue Biopsy Study (Premarketing)  
• Participants:

AC Panel member-Lynn Drake, MD  (Dermatologist/Dermatopathologist)
  FDA-Changting Haudenschild, Bruce  Schneider, Yoa-Yao Zhou, Agnes Lim, Wilson Bryan, and (Dr. Eriko Fukuda, Japan  PMDA-guest observer)

FDA asked Dr. Drake whether or not definition for scars  needs to be pre-defined in the post-injection biopsy study (20 subjects) that  was discussed in the last teleconference (10.20.09).

Dr. Drake’s response: These cannot be defined prospectively. In  general, tissues should be stained to look at collagens, for the sponsor to  show that the product is safe and to answer the question “What happens after it  is injected?” Dermatopathologist and general pathologists can tell if it is a  scar or not, and can distinguish minimum scars from extensive scars as well as  to see if there are granulomas or necrosis.

Will biopsy in 20 subjects give information that can tell us  accurately whether the product is safe or not?

Dr. Drake’s response: To see if the study is adequately powered would  need input from a statistician. In a small 20 subject study, the results can be  presented in descriptive languages. This would provide useful information in  the labeling.

Bruce agreed that information obtained in a biopsy study in  20 subjects would provide useful information, and gave an example where a  similar small study was conducted for Fosamax.

Addition  recommendations from Dr. Drake were as follows:

• Biopsies  should be done in an area with motion, e.g. in the forearm.  
• Subjects  should be in their 40s and 50s, not in the elderly.  
• Include  stains for collagen and elastin.