First clinical experience using a 'pathotropic' injectable retroviral vector (Rexin-G) as intervention for stage IV XXXX .

@entity1 @entity788 @entity137 @entity8 @entity390 @entity5 @entity391 @entity33 @entity236 @entity136
Metastatic or non-resectable (stage IV) @entity788 has a rapidly fatal outcome (median survival: 3-6 months), thus making gene therapy a viable therapeutic option. The objectives of the clinical studies are to evaluate the safety/ @entity137 and potential anti- @entity5 response/efficacy of intravenous (i.v.) infusions of a 'pathotropic' retroviral vector bearing a cytocidal gene construct (Rexin-G) as a gene transfer intervention for stage IV @entity788 . An intra- @entity1 dose escalation regimen was used wherein increasing doses of Rexin-G were given i.v. daily for 8-10 days. Completion of this regimen was followed by a one-week evaluation period for @entity137 , after which, the maximum tolerated dose of Rexin-G was administered for another 8-10 days. In a second protocol, i.v. Rexin-G was administered frontline for 6 days followed by 8 doses of weekly @entity136 . The NIH Common @entity137 Criteria Vs.2 was used to assess @entity137 , and the NCI-RECIST criteria and @entity5 volume measurements were used to evaluate potential anti- @entity5 responses. We report the results of the first 3 @entity1 that participated in the studies. Rexin-G arrested @entity5 growth in 3 of 3 @entity1 without experiencing dose-limiting @entity137 . No @entity236 , significant alterations in @entity8 , @entity390 and @entity391 , @entity33 or hair loss were observed. Two @entity1 are alive with stable disease approximately 5 and 14 months from diagnosis, and 1 @entity1 is alive with progressive disease 20 months from diagnosis. The encouraging results of this first clinical experience will guide the design and planning of phase I/II clinical trials to establish the safety and efficacy of Rexin-G as the first targeted injectable gene therapy vector for stage IV @entity788 .
