Article Excerpt:
TWST: We'd like to begin with a brief historical sketch of GenVec and a picture of the things you are doing at the present time.Dr. Fischer: GenVec was founded in 1993 to explore the promise of using genes to produce proteins where they are needed in the body to treat or prevent disease. Over the course of the last 10 to 12 years, we have looked at a number of different applications of our technology, but the most promising and furthest along are in cancer and vaccines. Our technology works the same way in both cases. For vaccines, the protein that needs to be produced tends to be a foreign protein, such as a protein from a virus or a pathogen, and the idea is to stimulate the body to launch an immune response against that protein. A unique advantage of our adenovector-based platform technology is that tests conducted to date indicate that it triggers a robust antibody and cellular response, which is key to many of the new approaches for vaccines. For cancer, we use the same adenovector-based platform technology to cause the production of a therapeutic protein called tumor necrosis factor, or TNF. TNF is known to destroy the vasculature of tumors and also turns on an immune response. At this time, our investigational drug for cancer, TNFerade, is being tested in the Phase II/III PACT trial in patients with locally advanced, unresectable pancreatic cancer. We've done earlier-stage studies of TNFerade in patients with esophageal and other cancers, and TNFerade is also being tested for the treatment of rectal cancer, metastatic melanoma, and head and neck cancer. So we will have a chance to build value in that program through expanded indications. Our work to date in pancreatic cancer has been very encouraging. This is a very difficult cancer to treat. However, during the dose-finding portion of our Phase II study in locally advanced, unresectable pancreatic cancer, we saw a greater percentage of tumor shrinkage in the patients treated at the Maximum Tolerated Dose (MTD) compared with the average response reported in ten recent studies, better survival in patients treated at the MTD, and encouraging results in a number of parameters that suggested a dose-dependent increase in clinical benefit to study patients receiving TNFerade in combination with standard therapy versus standard therapy alone. This led us to advance TNFerade into the randomized controlled Phase II/III PACT study, where we are again using the investigational drug in combination with standard therapy, which in this case is radiation therapy and Fluorouracil. Patients in the PACT trial also get the standard maintenance chemotherapeutics, Gemcitabine and/or Tarceva. We are very excited to see this drug candidate advance into a late-stage clinical trial. Our vaccine program has also made great progress and today we have a number of collaborations with leading researchers in infectious disease. Our HIV vaccine collaboration with the Vaccine Research Center, or VRC, of the National Institute of Allergies and Infectious Disease at the National Institutes of Health is focused on generating an immune response against the HIV virus and preventing viral infection. The VRC is testing our adenovector-based vaccine in conjunction with its trial consortium partners. Today there are approximately 1,000 people participating in a variety of Phase I and Phase II studies that are being conducted by the VRC and its clinical trial consortium, which expects to start a 10,000-subject international multi-center HIV vaccine study in the first quarter of next year. This will be conducted in areas of the world where there is a high HIV infection rate and where we should be able to assess the vaccine's impact on disease protection and transmission. The VRC is also conducting a small Phase I study to test whether the HIV vaccine can be used to treat HIV- positive patients. So we are very excited about that program. We also have collaborations with the U.S. Navy and the Malaria Vaccine Initiative to develop malaria vaccines, and with the U.S. Department of Agriculture in a program funded by the Department of Homeland Security to develop a prevention strategy for foot and mouth disease in livestock. So, at this point, GenVec's technology is being widely tested in a variety of different disease settings or in volunteers as we move forward in the vaccine studies.
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