Cervical cancer is one of the most common cancers in women worldwide, with about 450,000 new cases diagnosed each year. In the United States, widespread screening (the Pap smear) has reduced mortality by 70% and reduced incidence to approximately 15,000 new cases annually. Approximately 35% of U.S. patients will develop advanced, metastatic disease, for which treatment results are poor. Specific strains of human papillomavirus (HPV) are known to represent important risk factors in the development of cervical cancer. An experimental vaccine has been developed that involves stimulating dendritic cells from the patient by exposure to two marker proteins from specific strains of HPV. The stimulated cells are injected into the patient, which produces an immune response to the tumor. The vaccine depends on having a reliable supply of the two marker proteins. We plan on applying recombinant DNA technology to induce a genetically modified (GM) strain of canola to produce these proteins in seeds. In this phase, we will develop the methodology for genetically modifying the plants and will prove the presence of E6 and E7 in the seeds. This work will lay the foundation for the eventual development of a commercial route to produce both proteins. The proposed research, if successful, will determine if these two proteins can be produced in a system employing green plants as manufacturing units. These data will form the foundation for future Phase II work, which will be directed at developing a commercially viable purification process for the two proteins from seed matter. Also, data from growing the GM plants in the greenhouse will be used to provide information for growing the GM plants in the field and for controlling the proper variables so that current good manufacturing practices are observed in the field production and purification processes. Phase III research and development will be aimed at scaling the process to enable production of all of the E6 and E7 needed for this particular application. Ultimately, if this project is successful, the production of the two proteins in this manner will make the experimental vaccine for the treatment of cervical cancer widely available. Lastly, the work in this phase will provide data that will be used in the development of plant systems for the production of a pipeline of therapeutic proteins, which ArPharm Biotechnology intends to commercialize. These proteins, many of which are currently being tested as potential treatments, will be directed towards treatments of cancers of the reproductive system and for the treatment of sexually transmitted diseases.
