Over a million women each year are diagnosed with cervical dysplasia. The only effective treatment is surgery which removes a significant portion of the cervix and can decrease childbearing potential. An NIH panel concluded that effective therapies for human papilloma virus associated cervical dysplasia are likely to be immune mediators. The therapeutic described in this application is designed to activate CTL responses that will eliminate virally infected cells and lead to regression of the cervical lesions. The drug consists of a plasmid DNA encoding HPV specific CTL epitopes. Plasmid DNA is non-integrating, non-replicating and has proven to be safe in clinical trials thus far. The plasmid is encapsulated in a novel polymeric biodegradable compound that has previously been approved by the FDA for use in humans. Encapsulation in the polymer serves to protect the DNA and target it to professional antigen presenting cells. These characteristics should increase the effectiveness of plasmid DNA vaccination for this and other diseases. The goal of this research is to optimize the polymer drug delivery system and DNA encapsulation procedures. The formulations will be tested for their ability to elicit CTL responses in animals. Pharmacokinetic parameters will be studied to support filing with the FDA.
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