FINAL PROGRAM - American Society of Gene & Cell Therapy

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13 th AnnUAL MEETing | Washington, DC USA May 19-22, 2010 65Program ScheduleFoundation Symposium 3407:00 pm - 10:00 pmRoom: Marriott Ballroom Salons 2 & 3Progress and Prospects for Gene Therapy for CGD and other Primary ImmunodeficienciesSpeakersMary C. Dinauer, MD, PhDGene Therapy for CGD - From Basic Discoveries to the Start of Clinical TrialsAlessandro Aiuti, MD, PhDConditioning Regimens for Haematopoietic Gene TherapyHarry L. Malech, MDUpdate on Gene Therapy Trials for CGDManuel Grez, PhDThe European Experience on GT for CGDAdrian J. Thrasher, MD, PhDUpdate on Clinical Trials for XC1-SCID, ADA and ALDFoundation Symposium 340 is supported by the following ASGCT partner:Friday, May 21 st
66American Society of Gene & Cell TherapyProgram ScheduleSaturday, May 22ASGCT Business Meeting8:00 am - 8:30 amRoom: Delaware SuiteA light continental breakfast will be served at 7:45 am.Scientific Symposium 4008:30 am - 10:30 amRoom: Maryland SuiteLate Stage Industry Clinical TrialsCo-ChairsDouglas J. Jolly, PhD & Thomas TillettSpeakersWilliam W. Li, MDGene Transfer of FGF1 for Critical Limb Ischemia: A Phase III Clinical TrialRobert Sims, MDProgress in the Development of Sipuleucel-T for the Treatment of Men with Metastatic, Castrate Resistant Prostate CancerSipuleucel-T is an autologous cellular immunotherapy designed to elicit an antitumor response against prostate cancer. Sipuleucel-T is manufactured by incubating antigenpresenting cell precursors with a fusion protein composed of prostatic acid phosphatase linked to GM-CSF. Sipuleucel-T is then reinfused into the patient and the process isrepeated every 2 weeks for a total of 3 infusions. It has been evaluated in 3 randomized placebo-controlled Phase 3 studies in men with metastatic castrate-resistant prostatecancer, which have demonstrated clear evidence of prolongation of survival. The presentation will include an update on the regulatory status of sipuleucel-T currentclinical trials, as well as planned future trials.Ryuichi Morishita, MD, PhDDevelopment of HGF Gene Therapy Drug (Collategen)As HGF is a most potent mitogen to stimulate angiogenesis, a multi-center randomized, placebo-controlled, double blind study for critical limb ischemia (CLI) using HGFplasmid DNA was conducted, based on phase I/IIa open label study at Osaka University. Improvement rate was 70.4 % in HGF and 30.8% in placebo in Fontaine III/Rutherford 4 patients (P=0.014). HGF gene therapy achieved a significantly higher improvement rate of ischemic ulcers compared with placebo (100% vs. 40%,P=0.018). No major safety problems were observed. Based on phase III data, NDA was submitted to Japan Regulatory Agency (MHWL) on 2008. In USA, phase IIIstudy using HGF gene therapy will be started in 2010, since phase III USA study obtained SPA from FDA.Sander van Deventer, MD, PhDGlybera for Lipoprotein Lipase DeficiencySaturday, May 22 ndEXHIBITOR PROSPECTUSfinal program
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