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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. Arnie Kuzmak and Tony DeCamp from the Parkinson Pipeline Project will be attending the meeting and plan to comment on it during the 15 min. public comment period. CERE-120 (neurturin) is a neural growth factor, closely related to GDNF. The cliinical trial is expected to begin around the end of the yeear, 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/meetings/Jun2009/FINAL%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_meeting_2006_webcasts.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. " www.pdpipeline.org __._,_.___ Your email settings: Individual Email|Traditional Change settings via the Web (Yahoo! ID required) Change settings via email: Switch delivery to Daily Digest | Switch to Fully Featured Visit Your Group | Yahoo! Groups Terms of Use | Unsubscribe __,_._,___ ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn