FYI
The NIH Recombinant DNA Advisory committee RAC) will be reviewing the trial protocol for the new CERE-120 clinical trial (Phase I/II) on Wed. , June 17 at 10:30.
You can watch a live web cast of the meeting at :

http://videocast.nih.gov/summary.asp?live=7699

The agenda is below

Wednesday, June 17, 2009 (continued)

"10:50 AM Discussion of Human Gene Transfer Protocol #0904-981: A Phase 1/2 Trial Assessing the Safety and Efficacy of Bilateral Intraputaminal and Intranigral Administration of CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN]) in Subjects with Idiopathic Parkinson’s Disease

PIs: William J. Marks, Jr., M.D., University of California, San Francisco, CA

Mark Stacy, M.D. Duke University, Durham, NC

Sponsor: Ceregene, Inc.

RAC Reviewers: Hildegund C.J. Ertl, M.D.

Robyn S. Shapiro, J.D.

Lee-Jen Wei, Ph.D.

James R. Yankaskas, M.D., M.S.

Ad hoc Reviewers: John D. Elsworth, Ph.D., Yale University, New Haven, CT

Thomas Freeman, M.D., University

of South Florida, Tampa, FL

Tab 2561 Protocol

Tab 2562 OBA Summary

OBA Letter to PI on In-Depth RAC Review and Public Discussion

Reviews from Drs. Elsworth, Ertl, Freeman, Wei, Yankaskas and Ms. Shapiro PI’s Response

12:45 PM Public Comment

http://oba.od.nih.gov/oba/RAC/meetin...INAL%20RAC.pdf



You might also find interesting the earlier RAC meeting for the frirst recently completed CERE-120 phase II trial . It was held on Sept. 20, 2006 and is availab le on the RAC's archive of meetings at:

http://oba.od.nih.gov/rdna/rac_past_...sts.html#sep06

About the RAC

" The RAC is a technical committee whose goal is to consider the current state of knowledge and technology regarding recombinant DNA. This includes review of human gene transfer trials, and an assessment of the ability of DNA recombinants to survive in nature and the potential for transfer of genetic material to other organisms. It also considers hypothetical hazards and methods for monitoring and minimizing risks. Approximately one-third of the 15 members do not have scientific expertise but represent public interests and attitudes. This balance is intended to provide a forum for open public debate of social and scientific issues attendant to recombinant DNA research. The RAC has been overwhelmingly successful in achieving this goal. "