UNASSIGNED: 161 Background: A new @entity5 therapeutic gene; @entity5977 was found in Okayama university in 2000. In vivo experiments have demonstrated outstanding @entity5 -selective apoptosis effects and anti- @entity5 immunoactivity against various types of @entity5 . With these positive experimental results, a phase I/II study of @entity17472 -mediated @entity5977 gene therapy for @entity263 was initiated from January 2011 in Okayama university hospital. METHODS: Two major inclusion criteria category were set up; A: A recurrence of @entity263 following definitive endocrine therapy with/without metastasis, B: A @entity263 which was considered high risk of recurrences following radical surgery according to a nomogram reported by Kattan et al. Replication-defective @entity17472 vector expressing @entity5977 (Ad- @entity5977 ) was injected directly into the prostate (or metastatic lesion in @entity1 who received prostatectomy) in escalating doses from 1.0*10(10) to 1.0*10(12) viral particle (vp). Each @entity1 in category A received total of 2 times viral injections every 4 weeks. @entity1 in category B also received total of 2 times viral injections every 2 weeks, then received radical prostatectomy 6 weeks after second viral injection. RESULTS: Three @entity1 in category A, and 9 @entity1 in category B were entered the present study. No significant side effects were observed. In category B, signs of immunological responses in surgically removed specimens (apoptosis induction of @entity5 cells in TUNEL staining and infiltration of CD8 positive cells (CTL) in immunohistochemical staining) were observed in second dose. These responses were remarkably observed in the third dose. CONCLUSIONS: This initial and preliminary report suggests the favorable safety profile and positive clinical responses in a clinical trial of Ad- @entity5977 gene therapy for @entity263 .

A phase I/II study of @entity17472 -mediated reduced expression in immortalized cells ( @entity5977 ) gene therapy for XXXX : An interim report.

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients', 'patient'] @entity263 :: ('MESH:D011471', 'Disease') :: ['localized prostate cancer', 'prostate cancer'] @entity5 :: ('MESH:D009369', 'Disease') :: ['malignant tumors', 'cancer'] @entity5977 :: ('27122', 'Gene') :: ['REIC', 'REIC/Dkk-3'] @entity17472 :: ('10535', 'Species') :: ['adenovirus']
@entity263 :: (MESH:D011471,Disease) :: ['prostate cancer']
